Phase 2
Completed N=38
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
Source: ClinicalTrials.gov NCT01565889 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7 — 867.5; 627.6; 2269.4; 1421.5 h*ng/mL
Summary
This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics of sofosbuvir (GS-7977; PSI-7977) and its metabolites in participants with HIV and hepatitis C virus (HCV) coinfection. Part B, the Phase 2 treatment study, will investigate the efficacy and safety of sofosbuvir, pegylated interferon alpha (PEG) and ribavirin (RBV) in participants with HIV/HCV coinfection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7 |
867.5; 627.6; 2269.4; 1421.5; 1687.1; 95094.4 | — |
| PRIMARY Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7 |
635.0; 285.1; 1228.9; 828.2; 1189.2; 5423.8 | — |
| PRIMARY Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
91.3 | — |
| PRIMARY Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
0; 0; 0; 0; 0; 8.7 | — |
| SECONDARY Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
91.3; 91.3 | — |
| SECONDARY Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse |
0; 8.7 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy according to medical history and physical examination with exception of HCV and HIV diagnoses
- Confirmation of Chronic HCV infection
- Confirmation of Chronic HIV-1 infection
- On a stable protocol approved HIV antiretroviral (ARV) regimen with undetectable HIV-RNA
- Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
- Subjects must be naive to treatment for chronic HCV infection
Exclusion Criteria
- Known or suspected cirrhosis
- History of any other clinically significant chronic liver disease
- A history consistent with decompensated liver disease.
- Use of any prohibited medications as defined by the protocol
- Pregnant or nursing female or male with pregnant female partner
- Contraindication to PEG or RBV therapy (for Part B)
- Clinically relevant drug or alcohol abuse
Data sourced from ClinicalTrials.gov (NCT01565889). 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. Informational only — not medical advice.