Hepatitis C, Hepatitis C, Chronic
Conditions
Brief summary
Treatment compliance is a key success factor in obtaining the full benefit of Pegetron (peginterferon alfa-2b \[PegIFN-2b\] plus ribavirin combination) therapy for patients. Treatment-naïve patients with chronic hepatitis C (CHC) in Canada to whom Pegetron Redipen was prescribed will receive Pegetron Redipen therapy in accordance with approved labeling. The study will assess the effect of the newly approved Pegetron Redipen on treatment compliance and its effect on sustained virologic response rates. Sustained virologic response is defined as negative hepatitis C virus ribonucleic acid (HCV-RNA) six months post-treatment.
Interventions
BIOLOGICALPegIFN-2b
PegIFN-2b powder for solution adminstered subcutaneously using the newly approved Redipen. Dosing per approved labeling
DRUGRibavirin
Ribavirin capsules administered orally. Dosing in accordance with approved labelling.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Treatment-naïve patients with chronic hepatitis C * Adults (\>18 years of age) * Prescribed Pegetron Redipen * Must meet all requirements for treatment with Pegetron Redipen * Must be able to obtain reimbursement of medication through private or provincial coverage
Exclusion criteria
* Active hepatitis B virus (HBV) infection (hepatitis B surface antigen \[HBsAg\] positive) * HIV antibody positive * Post liver transplant patients * Any other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1) | Up to 72 weeks | This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid \[HCV-RNA\]) at either of the follow-up evaluation time points (12 weeks \[window 10-14 weeks\] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1) | Up to 62 weeks | This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1) | Up to 72 weeks | This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving SVR (Stage 2) | Up to 72 weeks | SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response no. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1) | Up to 62 weeks | Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no. |
| The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1) | Up to 72 weeks | SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no. |
| The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) | Up to 62 weeks | Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals. |
| The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1) | Up to 62 weeks | Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \[scarred\] and connects with other scarred areas, and F4 = severe damage \[cirrhosis\] and liver no longer functions properly). |
| Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1) | Up to 72 weeks | SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 = significant liver damage, the liver is fibrotic \[scarred\] and connects with other scarred areas, and F4 = severe damage \[cirrhosis\] and liver no longer functions properly). |
| Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) | Up to 72 weeks | SVR was defined as HCV-RNA negative at ≥22 weeks following EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals. |
| Number of Participants Achieving SVR by Viral Load (Stage 1) | Up to 72 weeks | SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (\<100,000 Iu/mL). |
| Number of Participants Achieving SVR by Weight (Stage 1) | Up to 72 weeks | SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Up to 72 weeks | SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \[scarred\] and connects with other scarred areas, and F4 = severe damage \[cirrhosis\] and liver no longer functions properly). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals. |
| Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Up to 72 weeks | SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (\<100,000 Iu/mL). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals. |
| Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Up to 72 weeks | SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals. |
| Number of Participants Achieving EVR (Stage 1) | From Week 10 to Week 14 | EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving SVR by EVR Type (Stage 1) | Up to 72 weeks | EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving SVR by Gender (Stage 1) | Up to 72 weeks | SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving SVR by Race (Stage 1) | Up to 72 weeks | SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1) | Up to 72 weeks | SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. |
| Number of Participants With End of Treatment (EOT) Response (Stage 1) | Up to 48 weeks | EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as not done then EOT was set to no. |
| Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1) | Up to 72 weeks | EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV-RNA Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as not done then EOT was set to no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals. |
| Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1) | Week 12 | EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at TW12. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals. |
| Relapse Rate by HCV Genotype (Stage 1) | Up to 48 weeks | The relapse rate was calculated with these parameters: EOT yes, EVR evaluation valid, and ≥22 weeks of follow-up data. There were no imputations for EOT or SVR. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals. |
| Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1) | Up to 48 weeks | An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals. |
| Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2) | Week 4 | RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving EVR (Stage 2) | Week 12 | EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving RVR by Race (Stage 2) | Week 4 | RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving EVR by Race (Stage 2) | Week 12 | EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving SVR by Race (Stage 2) | Up to 72 weeks | SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving RVR Who Achieved SVR (Stage 2) | Week 4 | RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving EVR Who Achieved SVR (Stage 2) | Week 12 | EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) | Week 4 | RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \[scarred\] and connects with other scarred areas , and F4 = severe damage \[cirrhosis\] and liver no longer functions properly). |
| Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) | Week 12 | EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \[scarred\] and connects with other scarred areas , and F4 = severe damage \[cirrhosis\] and liver no longer functions properly). |
| Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) | Up to 72 weeks | SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \[scarred\] and connects with other scarred areas , and F4 = severe damage \[cirrhosis\] and liver no longer functions properly). |
| Number of Participants Achieving RVR by Weight (Stage 2) | Week 4 | RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving EVR by Weight (Stage 2) | Week 12 | EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving SVR by Weight (Stage 2) | Up to 72 weeks | SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Week 4 | RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype. |
| Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Week 12 | EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype. |
| Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Up to 72 weeks | SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype. |
| Number of Participants Achieving RVR by Gender (Stage 2) | Week 4 | RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving EVR by Gender (Stage 2) | Week 12 | EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving SVR by Gender (Stage 2) | Up to 72 weeks | SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving RVR by HIV Status (Stage 2) | Week 4 | RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response no. |
| Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2) | Up to 48 weeks | An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment |
| Number of Participants Achieving SVR by HIV Status (Stage 2) | Up to 72 weeks | SVR was defined as HCV-RNA negative at six months following EOT. Participants with no viral response information were considered viral response no. |
| Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2) | Up to 72 weeks | Compliance was defined as participants taking ≥80% versus \<80% of their doses; compliance ≥80% was derived from participants who answered always or most of the time to Questions 4 (How often do you stick to your medication schedule for your Ribavirin?) and 5 (How often do you stick to your medication schedule for your Redipen \[peginterferon\] injections?) of the 6-question compliance questionnaire. Percentages are based on the total number of participants within each compliance category. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving EVR by HIV Status (Stage 2) | Week 12 | EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1) | Up to 72 weeks | Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1) | Up to 62 weeks | Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no. |
| Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1) | Up to 72 weeks | SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stage 1 Participants Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites. | 1,302 |
| Stage 2 Participants Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites. | 1,128 |
| Total | 2,430 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 76 | 142 |
| Overall Study | Assigned shorter treatment | 0 | 2 |
| Overall Study | Financial reasons | 0 | 2 |
| Overall Study | Geographic reasons | 0 | 11 |
| Overall Study | Incarceration | 0 | 9 |
| Overall Study | Lack of virologic response | 94 | 202 |
| Overall Study | Lost to Follow-up | 0 | 52 |
| Overall Study | Patient choice | 0 | 26 |
| Overall Study | Reason not specified | 193 | 7 |
| Overall Study | Substance abuse | 0 | 3 |
| Overall Study | Unknown, missing data | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Stage 1 Participants | Stage 2 Participants | Total |
|---|---|---|---|
| Age, Customized 24 to < 40 years | 275 Participants | 217 Participants | 492 Participants |
| Age, Customized <25 years | 23 Participants | 12 Participants | 35 Participants |
| Age, Customized 40 to < 55 yeats | 783 Participants | 671 Participants | 1454 Participants |
| Age, Customized >55 years | 221 Participants | 228 Participants | 449 Participants |
| Sex: Female, Male Female | 432 Participants | 346 Participants | 778 Participants |
| Sex: Female, Male Male | 870 Participants | 782 Participants | 1652 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)
This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT population)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1) | 638 Participants |
Primary
Number of Participants Achieving SVR (Stage 2)
SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR (Stage 2) | 468 participants |
Primary
Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)
This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response no.
Time frame: Up to 62 weeks
Population: All participants who took at least one dose of study medication (ITT population)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1) | 660 Participants |
Primary
Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)
This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid \[HCV-RNA\]) at either of the follow-up evaluation time points (12 weeks \[window 10-14 weeks\] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1) | 685 participants |
Secondary
Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.
Time frame: Week 12
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Genotype 1a (n=176) | 106 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Genotype 1b (n=74) | 51 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Genotype unknown (n=850) | 518 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Genotype mixed (n=14) | 8 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Could not be determined (n=14) | 7 participants |
Secondary
Number of Participants Achieving EVR by Gender (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no.
Time frame: Week 12
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving EVR by Gender (Stage 2) | Female (n=346) | 227 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Gender (Stage 2) | Male (n=782) | 463 participants |
Secondary
Number of Participants Achieving EVR by HIV Status (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no.
Time frame: Week 12
Population: This analysis was not done.
Secondary
Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \[scarred\] and connects with other scarred areas , and F4 = severe damage \[cirrhosis\] and liver no longer functions properly).
Time frame: Week 12
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) | F0 (n=66) | 49 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) | F1 (n=144) | 95 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) | F2 (n=212) | 133 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) | F3 (99) | 62 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) | F4 (n=110) | 53 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) | Could not be determined (n=463) | 280 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) | Other (n=34) | 18 participants |
Secondary
Number of Participants Achieving EVR by Race (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no.
Time frame: Week 12
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving EVR by Race (Stage 2) | Aboriginal peoples/Metis (n=13) | 6 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Race (Stage 2) | Asian (n=54) | 42 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Race (Stage 2) | Black (n=20) | 8 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Race (Stage 2) | Caucasian (n=1002) | 609 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Race (Stage 2) | Hispanic (n=4) | 4 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Race (Stage 2) | Other (n=35) | 21 participants |
Secondary
Number of Participants Achieving EVR by Weight (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no.
Time frame: Week 12
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving EVR by Weight (Stage 2) | 40 to <50 kg (n=16) | 9 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Weight (Stage 2) | 50 to <64 kg (n=127) | 87 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Weight (Stage 2) | 64 to <75 kg (n=250) | 164 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Weight (Stage 2) | 75 to <85 kg (n=238) | 143 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Weight (Stage 2) | >=85 kg (n=490) | 283 participants |
| Stage 1 Participants | Number of Participants Achieving EVR by Weight (Stage 2) | Weight unknown (n=7) | 4 participants |
Secondary
Number of Participants Achieving EVR (Stage 1)
EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. Participants with no viral response information were considered viral response no.
Time frame: From Week 10 to Week 14
Population: The EVR analysis population comprised participants with HCV Genotypes 1, 4, and 6 only, who took at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | Number of Participants Achieving EVR (Stage 1) | 473 participants |
Secondary
Number of Participants Achieving EVR (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response no.
Time frame: Week 12
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | Number of Participants Achieving EVR (Stage 2) | 690 participants |
Secondary
Number of Participants Achieving EVR Who Achieved SVR (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no.
Time frame: Week 12
Population: All participants who took at least one dose of study medication and achieved EVR
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | Number of Participants Achieving EVR Who Achieved SVR (Stage 2) | 399 participants |
Secondary
Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)
RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response no.
Time frame: Week 4
Population: The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2) | 56 participants |
Secondary
Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)
RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.
Time frame: Week 4
Population: The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Genotype mixed (n=11) | 1 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Genotype 1a (n=147) | 17 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Genotype 1b (n=56) | 9 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Genotype unknown (n=160) | 26 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Could not be determined (n=14) | 3 participants |
Secondary
Number of Participants Achieving RVR by Gender (Stage 2)
RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response no.
Time frame: Week 4
Population: The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving RVR by Gender (Stage 2) | Female (n=122) | 19 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Gender (Stage 2) | Male (n=266) | 37 participants |
Secondary
Number of Participants Achieving RVR by HIV Status (Stage 2)
RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response no.
Time frame: Week 4
Population: This analysis was not done.
Secondary
Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)
RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \[scarred\] and connects with other scarred areas , and F4 = severe damage \[cirrhosis\] and liver no longer functions properly).
Time frame: Week 4
Population: The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) | F0 (n=28) | 4 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) | F1 (n=30) | 9 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) | F2 (n=49) | 8 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) | F3 (n=14) | 2 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) | F4 (n=27) | 1 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) | Could not be determined (n=206) | 29 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) | Other (n=34) | 3 participants |
Secondary
Number of Participants Achieving RVR by Race (Stage 2)
RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response no.
Time frame: Week 4
Population: The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving RVR by Race (Stage 2) | Aboriginal peoples/Metis (n=10) | 0 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Race (Stage 2) | Asian (n=19) | 6 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Race (Stage 2) | Black (n=8) | 0 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Race (Stage 2) | Caucasian (n=343) | 47 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Race (Stage 2) | Hispanic (n=1) | 0 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Race (Stage 2) | Other (n=7) | 3 participants |
Secondary
Number of Participants Achieving RVR by Weight (Stage 2)
RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response no.
Time frame: Week 4
Population: The RVR analysis population comprises 388 participants who took at least one dose of study medication and were evaluated for RVR
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving RVR by Weight (Stage 2) | 40 to <50 kg (n=3) | 0 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Weight (Stage 2) | 50-<64 kg (n=40) | 8 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Weight (Stage 2) | 64 to <75 kg (n=83) | 9 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Weight (Stage 2) | 75 to <85 kg (n=86) | 11 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Weight (Stage 2) | >=85 kg (n=169) | 27 participants |
| Stage 1 Participants | Number of Participants Achieving RVR by Weight (Stage 2) | Weight unknown (n=7) | 1 participants |
Secondary
Number of Participants Achieving RVR Who Achieved SVR (Stage 2)
RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no.
Time frame: Week 4
Population: Participants who achieved RVR
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | Number of Participants Achieving RVR Who Achieved SVR (Stage 2) | 35 participants |
Secondary
Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2)
SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Genotype 1a (n=176) | 58 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Genotype 1b (n=74) | 37 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Genotype Unknown (n=850) | 364 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Genotype mixed (n=14) | 5 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2) | Could not be determined (n=14) | 4 participants |
Secondary
Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \[scarred\] and connects with other scarred areas, and F4 = severe damage \[cirrhosis\] and liver no longer functions properly). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 1 (n=757) | 21 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 2 (n=172) | 4 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 3 (n=348) | 8 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 4 (n=21) | 0 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 6 (n=2) | 0 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Unknown Genotype (n=2) | 0 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 2 (n=172) | 17 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 4 (n=21) | 0 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Unknown Genotype (n=2) | 0 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 1 (n=757) | 55 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 3 (n=348) | 13 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 6 (n=2) | 0 participants |
| Stage F2 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Unknown Genotype (n=2) | 0 participants |
| Stage F2 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 6 (n=2) | 0 participants |
| Stage F2 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 4 (n=21) | 0 participants |
| Stage F2 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 3 (n=348) | 13 participants |
| Stage F2 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 1 (n=757) | 64 participants |
| Stage F2 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 2 (n=172) | 13 participants |
| Stage F3 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 4 (n=21) | 0 participants |
| Stage F3 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 2 (n=172) | 9 participants |
| Stage F3 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 3 (n=348) | 10 participants |
| Stage F3 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Unknown Genotype (n=2) | 0 participants |
| Stage F3 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 6 (n=2) | 2 participants |
| Stage F3 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 1 (n=757) | 28 participants |
| Stage F4 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 1 (n=757) | 25 participants |
| Stage F4 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 6 (n=2) | 0 participants |
| Stage F4 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 2 (n=172) | 2 participants |
| Stage F4 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 3 (n=348) | 9 participants |
| Stage F4 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 4 (n=21) | 2 participants |
| Stage F4 | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Unknown Genotype (n=2) | 0 participants |
| Unknown Stage | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 4 (n=21) | 3 participants |
| Unknown Stage | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 3 (n=348) | 154 participants |
| Unknown Stage | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 6 (n=2) | 0 participants |
| Unknown Stage | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Unknown Genotype (n=2) | 0 participants |
| Unknown Stage | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 2 (n=172) | 81 participants |
| Unknown Stage | Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) | Genotype 1 (n=757) | 105 participants |
Secondary
Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks following EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) | Genotype 1 (n=757) | 298 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) | Genotype 2 (n=172) | 126 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) | Genotype 3 (n=348) | 207 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) | Genotype 4 (n=21) | 5 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) | Genotype 5 (n=0) | 0 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) | Genotype 6 (n=2) | 2 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) | Genotype missing (n=2) | 0 participants |
Secondary
Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (\<100,000 Iu/mL). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Genotype 1 (n=757) | 222 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Genotype 2 (n=172) | 53 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Genotype 3 (n=348) | 74 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Genotype 4 (n=21) | 2 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Genotype 6 (n=2) | 2 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Unknown Genotype (n=2) | 0 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Unknown Genotype (n=2) | 0 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Genotype 1 (n=757) | 42 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Genotype 4 (n=21) | 3 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Genotype 6 (n=2) | 0 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Genotype 2 (n=172) | 4 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Genotype 3 (n=348) | 14 participants |
| Stage F2 | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Genotype 2 (n=172) | 69 participants |
| Stage F2 | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Genotype 3 (n=348) | 119 participants |
| Stage F2 | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Unknown Genotype (n=2) | 0 participants |
| Stage F2 | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Genotype 4 (n=21) | 0 participants |
| Stage F2 | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Genotype 1 (n=757) | 34 participants |
| Stage F2 | Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) | Genotype 6 (n=2) | 0 participants |
Secondary
Number of Participants Achieving SVR by EVR Type (Stage 1)
EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: The EVR analysis population comprised participants with HCV Genotypes 1, 4, 5, and 6 who took at least one dose of study medication. No participants had Genotype 5.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by EVR Type (Stage 1) | EVR by ≥2 log reduction from baseline (n=78) | 15 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by EVR Type (Stage 1) | EVR by HCV-RNA negative (n=389) | 253 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by EVR Type (Stage 1) | EVR missing (n=6) | 2 participants |
Secondary
Number of Participants Achieving SVR by Gender (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by Gender (Stage 1) | Female (n=432) | 241 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Gender (Stage 1) | Male (n=870) | 397 participants |
Secondary
Number of Participants Achieving SVR by Gender (Stage 2)
SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by Gender (Stage 2) | Female (n=346) | 167 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Gender (Stage 2) | Male (n=782) | 301 participants |
Secondary
Number of Participants Achieving SVR by HIV Status (Stage 2)
SVR was defined as HCV-RNA negative at six months following EOT. Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: This analysis was not done.
Secondary
Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1) | HIV status not done (n=216) | 92 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1) | HIV positive (n=11) | 3 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1) | HIV negative (n=1075) | 543 participants |
Secondary
Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)
SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \[scarred\] and connects with other scarred areas , and F4 = severe damage \[cirrhosis\] and liver no longer functions properly).
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) | Could not be determined (n=463) | 187 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) | F1 (n=144) | 72 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) | F0 (n=66) | 36 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) | F2 (n=212) | 94 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) | F3 (n=99) | 35 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) | F4 (n=110) | 35 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) | Other (n=34) | 9 participants |
Secondary
Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 = significant liver damage, the liver is fibrotic \[scarred\] and connects with other scarred areas, and F4 = severe damage \[cirrhosis\] and liver no longer functions properly).
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1) | F0 (n=59) | 33 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1) | F1 (n=159) | 85 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1) | F2 (n=216) | 90 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1) | F3 (n=128) | 49 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1) | F4 (n=111) | 38 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1) | Fibrosis stage unknown (n=629) | 343 participants |
Secondary
Number of Participants Achieving SVR by Race (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by Race (Stage 1) | Asian (n=78) | 59 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Race (Stage 1) | Black (n=18) | 9 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Race (Stage 1) | Caucasian (N=1110) | 524 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Race (Stage 1) | Hispanic (n=11) | 4 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Race (Stage 1) | Other (n=85) | 42 participants |
Secondary
Number of Participants Achieving SVR by Race (Stage 2)
SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by Race (Stage 2) | Aboriginal peoples/Metis (n=13) | 4 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Race (Stage 2) | Asians (n=54) | 37 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Race (Stage 2) | Black (n=20) | 5 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Race (Stage 2) | Caucasian (n=1002) | 407 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Race (Stage 2) | Hispanic (n=4) | 4 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Race (Stage 2) | Other (n=35) | 11 participants |
Secondary
Number of Participants Achieving SVR by Viral Load (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (\<100,000 Iu/mL).
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by Viral Load (Stage 1) | Viral load high (n=836) | 353 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Viral Load (Stage 1) | Viral load low (n=109) | 63 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Viral Load (Stage 1) | Viral load missing (n=357) | 222 participants |
Secondary
Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 1 (n=757) | 4 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 2 (n=172) | 5 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 3 (n=348) | 1 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 4 (n=21) | 0 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 6 (n=2) | 0 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype unknown (n=2) | 0 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 6 (n=2) | 1 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype unknown (n=2) | 0 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 1 (n=757) | 39 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 3 (n=348) | 31 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 4 (n=21) | 0 participants |
| Stage 2 Participants | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 2 (n=172) | 11 participants |
| Stage F2 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 4 (n=21) | 2 participants |
| Stage F2 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 6 (n=2) | 1 participants |
| Stage F2 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 1 (n=757) | 76 participants |
| Stage F2 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 3 (n=348) | 53 participants |
| Stage F2 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 2 (n=172) | 26 participants |
| Stage F2 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype unknown (n=2) | 0 participants |
| Stage F3 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 4 (n=21) | 3 participants |
| Stage F3 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 2 (n=172) | 26 participants |
| Stage F3 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 3 (n=348) | 47 participants |
| Stage F3 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype unknown (n=2) | 0 participants |
| Stage F3 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 6 (n=2) | 0 participants |
| Stage F3 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 1 (n=757) | 61 participants |
| Stage F4 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 6 (n=2) | 0 participants |
| Stage F4 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 3 (n=348) | 75 participants |
| Stage F4 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 2 (n=172) | 58 participants |
| Stage F4 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype unknown (n=2) | 0 participants |
| Stage F4 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 4 (n=21) | 0 participants |
| Stage F4 | Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) | Genotype 1 (n=757) | 118 participants |
Secondary
Number of Participants Achieving SVR by Weight (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by Weight (Stage 1) | 40 to <50 kg (n=21) | 10 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Weight (Stage 1) | 50 to <64 kg (n=160) | 82 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Weight (Stage 1) | 64 to <75 kg (n=297) | 158 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Weight (Stage 1) | 75 to <85 kg (n=283) | 137 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Weight (Stage 1) | >85 kg (n=541) | 251 participants |
Secondary
Number of Participants Achieving SVR by Weight (Stage 2)
SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR by Weight (Stage 2) | >=85 kg (n=490) | 193 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Weight (Stage 2) | Weight unknown (n=7) | 2 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Weight (Stage 2) | 40 to <50 kg (n=16) | 6 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Weight (Stage 2) | 50 to <64 (n=127) | 59 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Weight (Stage 2) | 64 to <75 kg (n=250) | 115 participants |
| Stage 1 Participants | Number of Participants Achieving SVR by Weight (Stage 2) | 75 to >85 kg (n=238) | 93 participants |
Secondary
Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: Participants in the ITT population with EVR evaluation at Treatment Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1) | 638 Participants |
Secondary
Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)
Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no.
Time frame: Up to 62 weeks
Population: Participants in the ITT population with EVR evaluation at Treatment Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1) | 660 Participants |
Secondary
Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)
Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: Participants in the ITT population with EVR evaluation at Treatment Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1) | 685 Participants |
Secondary
Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Time frame: Up to 48 weeks
Population: All participants who took at least one dose of study medication (ITT population); no participants had Genotype 5
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1) | Genotypes 1, 4, and 6 (n=780) | 52 Participants |
| Stage 1 Participants | Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1) | Genotype 2 and 3 (n=520) | 24 Participants |
Secondary
Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment
Time frame: Up to 48 weeks
Population: All participants who took at least one dose of study medication (ITT Population)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2) | 76 participants |
| Stage 2 Participants | Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2) | 142 participants |
Secondary
Number of Participants With End of Treatment (EOT) Response (Stage 1)
EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as not done then EOT was set to no.
Time frame: Up to 48 weeks
Population: All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | Number of Participants With End of Treatment (EOT) Response (Stage 1) | 800 participants |
Secondary
Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)
EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV-RNA Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as not done then EOT was set to no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Time frame: Up to 72 weeks
Population: All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1) | Genotype 1, 4, and 6 (N=780) | 405 particpants |
| Stage 1 Participants | Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1) | Genotype 2 and 3 (n=520) | 395 particpants |
| Stage 1 Participants | Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1) | Genotype missing (n=2) | 0 particpants |
Secondary
Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)
EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at TW12. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Time frame: Week 12
Population: The EVR analysis population comprised participants with HCV genotypes 1, 4, and 6 only, who took at least one dose of study medication; no participants had Genotype 5
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1) | Genotype 1 (n=757) | 461 Participants |
| Stage 1 Participants | Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1) | Genotypes 1,4, and 6 (n=780) | 473 Participants |
Secondary
Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2)
Compliance was defined as participants taking ≥80% versus \<80% of their doses; compliance ≥80% was derived from participants who answered always or most of the time to Questions 4 (How often do you stick to your medication schedule for your Ribavirin?) and 5 (How often do you stick to your medication schedule for your Redipen \[peginterferon\] injections?) of the 6-question compliance questionnaire. Percentages are based on the total number of participants within each compliance category. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: Participants who completed the MAQ questionnaire during the study and achieved SVR
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2) | Compliance < 80% (n=10) | 40.0 percentage of participants |
| Stage 1 Participants | Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2) | Compliance ≥80% (n=304) | 39.1 percentage of participants |
Secondary
Relapse Rate by HCV Genotype (Stage 1)
The relapse rate was calculated with these parameters: EOT yes, EVR evaluation valid, and ≥22 weeks of follow-up data. There were no imputations for EOT or SVR. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Time frame: Up to 48 weeks
Population: All participants who took at least one dose of study medication (ITT population) and had EOT yes and valid EVR evaluation ; no participants had Genotype 5
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | Relapse Rate by HCV Genotype (Stage 1) | Genotype 6 (n=2) | 0 Percentage of Participants |
| Stage 1 Participants | Relapse Rate by HCV Genotype (Stage 1) | Genotype 1 (n=251) | 11.5 Percentage of Participants |
| Stage 1 Participants | Relapse Rate by HCV Genotype (Stage 1) | Genotype 2 (n=123) | 3.2 Percentage of Participants |
| Stage 1 Participants | Relapse Rate by HCV Genotype (Stage 1) | Genotype 3 (n=217) | 9.7 Percentage of Participants |
| Stage 1 Participants | Relapse Rate by HCV Genotype (Stage 1) | Genotype 4 (n=5) | 40.0 Percentage of Participants |
Secondary
The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no.
Time frame: Up to 72 weeks
Population: Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1) | 612 participants |
Secondary
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)
Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response no. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Time frame: Up to 62 weeks
Population: All participants who took at least one dose of study medication (ITT population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) | Genotype 1 (n=757) | 308 Participants |
| Stage 1 Participants | The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) | Genotype 2 (n=172) | 129 Participants |
| Stage 1 Participants | The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) | Genotype 3 (n=348) | 215 Participants |
| Stage 1 Participants | The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) | Genotype 4 (n=21) | 6 Participants |
| Stage 1 Participants | The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) | Genotype 5 (n=0) | 0 Participants |
| Stage 1 Participants | The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) | Genotype 6 (n=2) | 2 Participants |
| Stage 1 Participants | The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) | Genotype unknown (n=2) | 0 Participants |
Secondary
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)
Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response no. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic \[scarred\] and connects with other scarred areas, and F4 = severe damage \[cirrhosis\] and liver no longer functions properly).
Time frame: Up to 62 weeks
Population: All participants who took at least one dose of study medication (ITT population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1 Participants | The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1) | F0 (n=59) | 34 Participants |
| Stage 1 Participants | The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1) | F1 (n=159) | 89 Participants |
| Stage 1 Participants | The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1) | F2 (n=216) | 95 Participants |
| Stage 1 Participants | The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1) | F3 (n=128) | 51 Participants |
| Stage 1 Participants | The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1) | F4 (n=111) | 40 Participants |
| Stage 1 Participants | The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1) | Fibrosis stage unknown (n=629) | 351 Participants |
Secondary
The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)
Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response no.
Time frame: Up to 62 weeks
Population: Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1 Participants | The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1) | 679 Participants |