Chronic Hepatitis C, Hepatitis C Virus
Conditions
Keywords
Hepatitis C Virus (HCV), Hepatitis C, Chronic Hepatitis C, interferon free, Hepatitis C Genotype 2, Hepatitis C Genotype 3, Hepatitis C Genotype 4, Hepatitis C Genotype 5, Hepatitis C Genotype 6
Brief summary
The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) in chronic HCV genotype 2 (GT2-), genotype 3 (GT3-), genotype 4 (GT4), genotype 5 (GT5-), or genotype 6 (GT6-) infected participants with or without cirrhosis.
Detailed description
The study consisted of four independent parts with treatment and post-treatment periods of enrollment. Parts 1 and 2 were the supportive/ exploratory parts (phase 2) of the study and part 3 and 4 were the confirmatory/ registrational parts (phase 3) of the study. In parts 1 and 2 of the study, ABT-493 and ABT-530 were co-administered as separate tablets. However, in parts 3 and 4 of the study, the ABT-493/ABT-530 co-formulated tablets were administered.
Interventions
Tablet
Tablet
Tablet
Tablet; ABT-493 co-formulated ABT-530
Sponsors
Study design
Eligibility
Inclusion criteria
* Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection. * Chronic HCV infection. * Participant had to be either HCV treatment-naïve or treatment-experienced. * Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).
Exclusion criteria
* History of severe, life-threatening or other significant sensitivity to any drug. * Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study. * Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. * Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). * HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 12 weeks after the last actual dose of study drug | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. |
| Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control | 12 weeks after the last actual dose of study drug | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 4 weeks after the last actual dose of study drug | SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 4 weeks after the last dose of study drug. |
| Percentage of Participants With On-treatment Virologic Failure | Up to end of treatment (treatment week 8, 12 or 16 depending on arm) or premature discontinuation from treatment | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment; confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. |
| Percentage of Participants With Post-treatment Relapse | From the end of treatment through 12 weeks after the last dose of study drug | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment, excluding reinfection. |
Participant flow
Recruitment details
Enrollment into arms H, I, K, M and N was not opened by AbbVie.
Pre-assignment details
Intent-to-treat population: all participants who received at least 1 dose of study drug
Participants by arm
| Arm | Count |
|---|---|
| Arm A ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 2 (GT2) -infected treatment naïve and treatment experienced participants without cirrhosis. | 25 |
| Arm B ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis. | 24 |
| Arm C ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided twice daily (BID) for 12 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis. | 25 |
| Arm D ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV genotype 3 (GT3) -infected treatment naïve and treatment experienced participants without cirrhosis. | 30 |
| Arm E ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis. | 30 |
| Arm F ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and weight-based ribavirin (RBV) divided BID for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis. | 31 |
| Arm G ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (40 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve and treatment experienced participants without cirrhosis. | 30 |
| Arm J ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT2 -infected treatment naïve and treatment experienced participants without cirrhosis. | 54 |
| Arm L ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 8 weeks in HCV GT3 -infected treatment naïve and for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis. | 53 |
| Arm O ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in HCV GT3 -infected treatment naïve participants with compensated cirrhosis and for 16 weeks in HCV GT3 -infected treatment-experienced participants with compensated cirrhosis. | 28 |
| Arm P ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD and RBV (800 mg) QD for 12 weeks in HCV GT3-infected treatment naïve and treatment-experienced participants with compensated cirrhosis. | 27 |
| Arm Q1 ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment naïve participants with cirrhosis. | 40 |
| Arm Q2 ABT-493/ ABT-530 (300 mg/ 120mg ) once daily (QD) for 12 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis. | 22 |
| Arm R1 ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants without cirrhosis. | 22 |
| Arm R2 ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 16 weeks in HCV GT3 -infected treatment experienced participants with cirrhosis. | 47 |
| Arm S1 ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT2 infected treatment naïve and treatment experienced participants without cirrhosis. | 145 |
| Arm S2 ABT-493/ ABT-530 (300 mg/ 120 mg) QD for 8 weeks in HCV GT4-6 infected treatment naïve and treatment experienced participants without cirrhosis. | 58 |
| Total | 691 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Enrolled into a Re-treatment Study | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 1 | 2 |
| Overall Study | Randomized but did'nt receive study drug | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Arm Q2 | Arm R1 | Arm R2 | Arm S1 | Arm A | Total | Arm S2 | Arm B | Arm C | Arm D | Arm E | Arm F | Arm G | Arm J | Arm L | Arm O | Arm P | Arm Q1 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized < 65 years | 18 participants | 19 participants | 39 participants | 128 participants | 21 participants | 616 participants | 49 participants | 21 participants | 22 participants | 28 participants | 29 participants | 30 participants | 28 participants | 44 participants | 52 participants | 26 participants | 24 participants | 38 participants |
| Age, Customized >= 65 years | 4 participants | 3 participants | 8 participants | 17 participants | 4 participants | 75 participants | 9 participants | 3 participants | 3 participants | 2 participants | 1 participants | 1 participants | 2 participants | 10 participants | 1 participants | 2 participants | 3 participants | 2 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 4 Participants | 11 Participants | 1 Participants | 65 Participants | 2 Participants | 2 Participants | 4 Participants | 4 Participants | 3 Participants | 5 Participants | 5 Participants | 6 Participants | 2 Participants | 4 Participants | 2 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 22 Participants | 43 Participants | 134 Participants | 24 Participants | 626 Participants | 56 Participants | 22 Participants | 21 Participants | 26 Participants | 27 Participants | 26 Participants | 25 Participants | 48 Participants | 51 Participants | 24 Participants | 25 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 11 Participants | 84 Participants | 9 Participants | 293 Participants | 21 Participants | 11 Participants | 7 Participants | 11 Participants | 16 Participants | 12 Participants | 15 Participants | 21 Participants | 21 Participants | 13 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 36 Participants | 61 Participants | 16 Participants | 398 Participants | 37 Participants | 13 Participants | 18 Participants | 19 Participants | 14 Participants | 19 Participants | 15 Participants | 33 Participants | 32 Participants | 15 Participants | 18 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 25 | 0 / 24 | 0 / 25 | 0 / 30 | 0 / 30 | 0 / 31 | 0 / 30 | 0 / 54 | 0 / 53 | 0 / 28 | 1 / 27 | 0 / 40 | 0 / 22 | 0 / 22 | 0 / 47 | 1 / 145 | 0 / 58 |
| other Total, other adverse events | 12 / 25 | 11 / 24 | 22 / 25 | 19 / 30 | 20 / 30 | 23 / 31 | 18 / 30 | 26 / 54 | 40 / 53 | 20 / 28 | 21 / 27 | 30 / 40 | 12 / 22 | 13 / 22 | 31 / 47 | 78 / 145 | 32 / 58 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 | 1 / 25 | 0 / 30 | 0 / 30 | 2 / 31 | 0 / 30 | 1 / 54 | 1 / 53 | 2 / 28 | 2 / 27 | 1 / 40 | 1 / 22 | 1 / 22 | 3 / 47 | 1 / 145 | 1 / 58 |
Outcome results
Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.
Time frame: 12 weeks after the last actual dose of study drug
Population: All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control | 98.5 percentage of participants |
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.
Time frame: 12 weeks after the last actual dose of study drug
Population: All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 96.0 percentage of participants |
| Arm B | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 100.0 percentage of participants |
| Arm C | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 100.0 percentage of participants |
| Arm D | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 93.3 percentage of participants |
| Arm E | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 93.3 percentage of participants |
| Arm F | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 93.5 percentage of participants |
| Arm G | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 83.3 percentage of participants |
| Arm J | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 98.1 percentage of participants |
| Arm L | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 94.3 percentage of participants |
| Arm O | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 96.4 percentage of participants |
| Arm P | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 100.0 percentage of participants |
| Arm Q1 | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 97.5 percentage of participants |
| Arm Q2 | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 90.9 percentage of participants |
| Arm R1 | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 95.5 percentage of participants |
| Arm R2 | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 95.7 percentage of participants |
| Arm S1 | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 97.9 percentage of participants |
| Arm S2 | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 93.1 percentage of participants |
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment; confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
Time frame: Up to end of treatment (treatment week 8, 12 or 16 depending on arm) or premature discontinuation from treatment
Population: All participants who received at least 1 dose of study drug (ITT population) with evaluable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm B | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm C | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm D | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm E | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm F | Percentage of Participants With On-treatment Virologic Failure | 3.2 percentage of participants |
| Arm G | Percentage of Participants With On-treatment Virologic Failure | 3.3 percentage of participants |
| Arm J | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm L | Percentage of Participants With On-treatment Virologic Failure | 1.9 percentage of participants |
| Arm O | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm P | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm Q1 | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm Q2 | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm R1 | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm R2 | Percentage of Participants With On-treatment Virologic Failure | 2.1 percentage of participants |
| Arm S1 | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
| Arm S2 | Percentage of Participants With On-treatment Virologic Failure | 0 percentage of participants |
Percentage of Participants With Post-treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment, excluding reinfection.
Time frame: From the end of treatment through 12 weeks after the last dose of study drug
Population: All participants who received at least 1 dose of study drug (ITT population) with evaluable data, completed treatment, and had HCV RNA \<LLOQ at the final treatment visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Percentage of Participants With Post-treatment Relapse | 0.0 percentage of participants |
| Arm B | Percentage of Participants With Post-treatment Relapse | 0.0 percentage of participants |
| Arm C | Percentage of Participants With Post-treatment Relapse | 0.0 percentage of participants |
| Arm D | Percentage of Participants With Post-treatment Relapse | 3.4 percentage of participants |
| Arm E | Percentage of Participants With Post-treatment Relapse | 6.7 percentage of participants |
| Arm F | Percentage of Participants With Post-treatment Relapse | 0.0 percentage of participants |
| Arm G | Percentage of Participants With Post-treatment Relapse | 7.1 percentage of participants |
| Arm J | Percentage of Participants With Post-treatment Relapse | 0.0 percentage of participants |
| Arm L | Percentage of Participants With Post-treatment Relapse | 2.0 percentage of participants |
| Arm O | Percentage of Participants With Post-treatment Relapse | 3.6 percentage of participants |
| Arm P | Percentage of Participants With Post-treatment Relapse | 0.0 percentage of participants |
| Arm Q1 | Percentage of Participants With Post-treatment Relapse | 0 percentage of participants |
| Arm Q2 | Percentage of Participants With Post-treatment Relapse | 9.1 percentage of participants |
| Arm R1 | Percentage of Participants With Post-treatment Relapse | 4.5 percentage of participants |
| Arm R2 | Percentage of Participants With Post-treatment Relapse | 2.2 percentage of participants |
| Arm S1 | Percentage of Participants With Post-treatment Relapse | 1.4 percentage of participants |
| Arm S2 | Percentage of Participants With Post-treatment Relapse | 0 percentage of participants |
Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)
SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 4 weeks after the last dose of study drug.
Time frame: 4 weeks after the last actual dose of study drug
Population: All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 96.0 percentage of participants |
| Arm B | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 100.0 percentage of participants |
| Arm C | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 100.0 percentage of participants |
| Arm D | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 93.3 percentage of participants |
| Arm E | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 93.3 percentage of participants |
| Arm F | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 93.5 percentage of participants |
| Arm G | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 93.3 percentage of participants |
| Arm J | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 98.1 percentage of participants |
| Arm L | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 96.2 percentage of participants |
| Arm O | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 96.4 percentage of participants |
| Arm P | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 100.0 percentage of participants |
| Arm Q1 | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 97.5 percentage of participants |
| Arm Q2 | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 95.5 percentage of participants |
| Arm R1 | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 95.5 percentage of participants |
| Arm R2 | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 95.7 percentage of participants |
| Arm S1 | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 97.9 percentage of participants |
| Arm S2 | Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) | 98.3 percentage of participants |