Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis

Hepatitis C Virus Infection Clinical Trial

Official title:

A Multicenter, Randomized, Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Decompensated Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996682
• Other study ID #: GS-US-342-4019
• Status: Completed
• Phase: Phase 3
• Start date: December 26, 2016
• Est. completion date: May 8, 2018

Study information

• Verified date: February 2019
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 8, 2018
• Est. primary completion date: February 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Key Inclusion Criteria:

• Chronic HCV-infected males and non-pregnant/non-lactating females

• Treatment naive or treatment experienced individuals

• Child-Pugh-Turcotte Score 7-12 at screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Communicable Diseases
• Fibrosis
• Hepatitis
• Hepatitis C
• Hepatitis C Virus Infection
• Infection
• Liver Cirrhosis
• Virus Diseases

Intervention

Drug:
• SOF/VEL
400/100 mg FDC tablet administered orally once daily
• RBV
Capsules administered orally in a divided daily dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Takehara T, Kurosaki M, Tanaka Y, Tatsumi T, Ikeda F, Takikawa Y, et al. Sofosbuvir/Velpatasvir with or without Ribavirin for 12 Weeks in HCV-Infected Japanese Subjects with Decompensated Cirrhosis [Presentation]. 54th Annual Meeting of Japan Society of H

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Primary	Percentage of Participants Who Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event		Up to 12 weeks
Secondary	Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)	SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.	Posttreatment Week 4
Secondary	Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)	SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.	Posttreatment Week 24
Secondary	Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment		Up to 12 weeks
Secondary	Change From Baseline in HCV RNA		Baseline and up to 12 weeks
Secondary	Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score	MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. "No change" was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; "Decrease" was assigned for differences that were less than or equal to -2; and "Increase" was assigned for values that were greater than or equal to 2.	Baseline to Posttreatment Week 24
Secondary	Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class	CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. CPT scores were calculated using prothrombin activation percentage for the coagulation parameter per Japan's standard.	Baseline to Posttreatment Week 24
Secondary	Percentage of Participants With Virologic Failure	Virologic failure was defined as: Breakthrough (confirmed HCV RNA = LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently = LLOQ through 8 weeks of treatment), or Relapse (HCV RNA = LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement).	Up to Posttreatment Week 24