Phase 4
N=6
Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C
Hepatitis C, Chronic · HIV
Bottom Line
View on ClinicalTrials.gov: NCT01925183 ↗Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Feb 2017
Primary outcome: Primary: Proportion of Subjects With Sustained Virologic Response (SVR12) — 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pegylated interferon alpha-2a (Drug); Ribavirin (Drug); Boceprevir (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Markus Peck-Radosavljevic
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With Sustained Virologic Response (SVR12) |
3; 2 | — |
| PRIMARY Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
3; 3; 0; 1 | — |
Summary
Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed treatment duration of 48 weeks is used.
The aim of this study is to assess efficacy and safety of response-guided triple-therapy with BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.
Eligibility Criteria
Inclusion Criteria
- Confirmed HIV infection (anti-HIV1/2 antibody positive).
- Chronic HCV infection (anti-HCV positive, HCV-RNA detectable for >6 months).
- HCV-GT 1 infection.
- Age ≥18 years and ≤65 years.
- No prior treatment with BOC/PEGIFN/RBV.
- CD4+ cell count >200 cells/µL.
- Stable antiretroviral therapy (ART) including tenofovir/emtricitabine (Truvada®, Gilead) and raltegravir (Isentress®, MSD) with HIV-RNA 12.3 kPa) with decompensated liver disease (Child-Pugh stage B/C).
- Chronic liver diseases other than hepatitis C virus infection (hepatitis B virus infection: HBsAg positivity, nonalcoholic steatohepatitis, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, cystic fibrosis).
- Significant cardiac disease (ejection fraction 1.5 mg/dL).
- Subjects taking medication(s) that is/are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events such as but not limited to, orally administered midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine).
- Contraindications for boceprevir (Victrelis®, MSD), pegylated interferon alpha-2a (Pegasys®, Roche) or ribavirin (Copegus®, Roche), as listed in section 4.3 of the respective summary of product characteristics (SmPCs).
- Ongoing alcohol abuse (average daily alcohol consumption >50g).
- Ongoing illicit drug abuse.
- Unwillingness to give written informed consent.
- Pregnancy and breastfeeding.
- Women wishing to become pregnant.
Data sourced from ClinicalTrials.gov (NCT01925183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.