Phase 3 N=268 Randomized Treatment

Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis

Hepatitis C Virus Infection

Bottom Line

View on ClinicalTrials.gov: NCT02201901 ↗

Enrolled (actual)

268

Serious AEs

17.6%

Results posted

Dec 2016

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: SOF/VEL (Drug); RBV (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gilead Sciences
Primary completion: Aug 2015

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	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT02201901). 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.