Phase 3
Completed N=107
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
Source: ClinicalTrials.gov NCT02480712 ↗Enrolled (actual)
107
Serious AEs
1.9%
Results posted
Jun 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 95.3 percentage of participants
◆ Published Evidence
Highly cited
160citations · ~18 / year
Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study.
Summary
The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.
Linked Publications
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Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
95.3 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
1.9 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
95.3; 95.3 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment |
25.7; 68.0; 92.2; 99.0; 100.0; 100.0 | — |
| SECONDARY HCV RNA Change From Baseline/Day 1 |
-4.47; -4.97; -5.15; -5.18; -5.17; -5.17 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
1.9 | — |
| SECONDARY Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment |
94.4; 97.1; 100; 96.3; 97.1; 100 | — |
| SECONDARY Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12 |
0.09; 0.04; 0.00; 0.04; 0.02; -0.06 | — |
Eligibility Criteria
Key Inclusion Criteria
- HCV RNA ≥ 10^4 IU/mL at screening
- HCV genotype 1, 2, 3, 4, 5, 6
- Cirrhosis determination, a fibroscan or liver biopsy may be required
- HIV-1 infection
- Use of protocol specified method(s) of contraception
- Screening laboratory values within defined thresholds
Key Exclusion Criteria
- Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
- Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC) or other malignancy (with the exception of certain resolved skin cancers)
- Screening ECG with clinically significant abnormalities
- Pregnant or nursing female or male with pregnant female partner
- Infection with hepatitis B virus (HBV)
- Use of any prohibited concomitant medications as described in the protocol
- Chronic use of systemically administered immunosuppressive agents
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02480712) and the linked publication. 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.