Hepatitis C, Hepatitis C, Chronic
Conditions
Brief summary
The objective of the study is to evaluate the costs associated with peginterferon alfa-2b (PegIntron) plus ribavirin (Rebetol) treatment for chronic hepatitis C in the Czech Republic. Only costs associated with rescue medication, concomitant therapy, disease monitoring, and medical intervention costs recognized by the treating institution as treatment-related expenses will be included in the analysis. The study will also evaluate the correlation between hepatitis C virus (HCV) therapy-related costs with ribavirin dosing and participant history.
Interventions
BIOLOGICALpeginterferon alfa-2b
Peginterferon alfa-2b administered in accordance with approved labeling, ie, 1.5 μg/kg weekly SC for 48 weeks for participants with hepatitis C virus (HCV) genotype 1 or for 24 weeks for participants with HCV genotype 2, 3.
DRUGribavirin
Ribavirin administered in accordance with approved labeling, ie, 800 mg/day for participants \<65 kg, 1000 mg/day for participants \>65 to \<85 kg, and 1200 mg/day for participants \>=85 kg, administered orally for 48 weeks for participants with HCV genotype 1 or for 24 weeks for participants with HCV genotype 2, 3.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with chronic hepatitis C * At least 18 years old * Eligibility determined based on the diagnosis and medical judgment only.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category | From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3 | SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Cost Per Participant With SVR Stratified by Ribavirin Dosage | From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3 | SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values. |
| Average Cost Per Participant With SVR Stratified by Prior Treatment Status | From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3 | SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peginterferon Alfa-2b and Ribavirin Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants \<65 kg, 1000 mg/day for participants \>65 to \<85 kg, and 1200 mg/day for participants \>=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3. | 698 |
| Total | 698 |
Baseline characteristics
| Characteristic | Peginterferon Alfa-2b and Ribavirin |
|---|---|
| Age, Continuous | 38 years |
| Sex: Female, Male Female | 300 Participants |
| Sex: Female, Male Male | 398 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category
SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.
Time frame: From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3
Population: Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Peginterferon Alfa-2b and Ribavirin | Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category | <= 64 kg (n=182) | 28,271 Czech Crown |
| Peginterferon Alfa-2b and Ribavirin | Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category | 65-85 kg (n=334) | 31,429 Czech Crown |
| Peginterferon Alfa-2b and Ribavirin | Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category | >= 85 kg (n=182) | 34,782 Czech Crown |
Secondary
Average Cost Per Participant With SVR Stratified by Prior Treatment Status
SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.
Time frame: From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3
Population: Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Peginterferon Alfa-2b and Ribavirin | Average Cost Per Participant With SVR Stratified by Prior Treatment Status | Treatment-Naive (n=543) | 30,109 Czech Crown |
| Peginterferon Alfa-2b and Ribavirin | Average Cost Per Participant With SVR Stratified by Prior Treatment Status | Previously Treated (n=155) | 37,486 Czech Crown |
Secondary
Average Cost Per Participant With SVR Stratified by Ribavirin Dosage
SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.
Time frame: From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3
Population: Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Peginterferon Alfa-2b and Ribavirin | Average Cost Per Participant With SVR Stratified by Ribavirin Dosage | 800 mg/day (n=167) | 31,119 Czech Crown |
| Peginterferon Alfa-2b and Ribavirin | Average Cost Per Participant With SVR Stratified by Ribavirin Dosage | 1000 mg/day (n=333) | 29,306 Czech Crown |
| Peginterferon Alfa-2b and Ribavirin | Average Cost Per Participant With SVR Stratified by Ribavirin Dosage | 1200 mg/day (n=198) | 35,621 Czech Crown |