Phase 3
Completed N=268
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
Source: ClinicalTrials.gov NCT02201901 ↗Enrolled (actual)
268
Serious AEs
17.6%
Results posted
Dec 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 83.3; 94.3; 87.8 percentage of participants — p=<0.001
◆ Published Evidence
Highly cited
809citations · ~74 / year
Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis.
Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.
Linked Publications (3)
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Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis.
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Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis.
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Patient-reported outcomes with sofosbuvir and velpatasvir with or without ribavirin for hepatitis C virus-related decompensated cirrhosis: an exploratory analysis from the randomised, open-label ASTRAL-4 phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
83.3; 94.3; 87.8 | <0.001 sig |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
1.1; 16.1; 4.4 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
92.2; 95.4; 90.0; 83.3; 94.3; 87.8 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 |
2.2; 14.9; 11.1; 34.4; 49.4; 39.3 | — |
| SECONDARY Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 |
-3.51; -3.63; -3.72; -4.24; -4.17; -4.38 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
12.2; 3.4; 8.9 | — |
| SECONDARY Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score |
55.1; 49.3; 50.7; 20.3; 25.3; 21.7 | — |
| SECONDARY Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score |
44.9; 53.3; 63.8; 43.5; 37.3; 27.5 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide written informed consent
- HCV RNA > 10^4 IU/mL at screening
- Chronic HCV infection (≥ 6 months)
- Confirmed CPT class B (7-9) at screening
Exclusion Criteria
- Current or prior history of solid organ transplantation, significant pulmonary disease, significant cardiac disease, or porphyria
- Inability to exclude hepatocellular carcinoma (HCC) by imaging within 6 months of baseline/Day 1
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Screening ECG with clinically significant abnormalities
- Prior exposure to SOF or any other nucleotide analogue HCV nonstructural protein 5B (NS5B) inhibitor or any HCV NS5A inhibitor
- Laboratory results outside of acceptable ranges at screening
Data sourced from ClinicalTrials.gov (NCT02201901) 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.