Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection

Hepatitis C Virus Infection Clinical Trial

— ASTRAL-3  

Official title:

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201953
• Other study ID #: GS-US-342-1140
• Secondary ID: 2014-001682-27
• Status: Completed
• Phase: Phase 3
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willing and able to provide written informed consent

• HCV RNA = 10^4 IU/mL

• HCV genotype 3

• Chronic HCV infection (= 6 months)

• Females of childbearing potential must have a negative serum pregnancy test

• Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Exclusion Criteria:

• Current or prior history of clinically-significant illness (other than HCV) that may interfere with subject treatment, assessment or compliance with the protocol

• Screening ECG with clinically significant abnormalities

• Laboratory results outside of acceptable ranges at Screening

• Pregnant or nursing female or male with pregnant female partner

• Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)

• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis C
• Hepatitis C Virus Infection
• Infection
• Virus Diseases

Intervention

Drug:
• SOF/VEL
400/100 mg FDC tablet administered orally once daily
• SOF
400 mg tablet administered orally once daily
• RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and = 75 kg = 1200 mg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  New Zealand,  Puerto Rico,  United Kingdom, 

References & Publications (3)

Asselah T, Charlton M, Feld J, Foster GR, Mcnally J, Brainard DM, et al. The ASTRAL Studies: Evaluation of SOF/GS-5816 Single Tablet Regimen for the Treatment of Genotype 1-6 HCV Infection [Poster P1332]. J Hepatol 2015;62:S855-S6.

Foster GR, Afdhal N, Roberts SK, Bräu N, Gane EJ, Pianko S, Lawitz E, Thompson A, Shiffman ML, Cooper C, Towner WJ, Conway B, Ruane P, Bourlière M, Asselah T, Berg T, Zeuzem S, Rosenberg W, Agarwal K, Stedman CA, Mo H, Dvory-Sobol H, Han L, Wang J, McNall — View Citation

Mangia, A., Roberts, SK., Pianko, S., Thompson, A at al. Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks Compared to Sofosbuvir with Ribavirin for 24 Weeks in Genotype 3 HCV Infected Patients: The Randomized Controlled Phase 3 ASTRAL-3 Study. Hepat

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 Permanently Discontinued Any Study Drug Due to an Adverse Event		Up to 24 weeks
Secondary	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug.	Posttreatment Weeks 4 and 24
Secondary	Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24		Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Secondary	Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24		Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Secondary	Percentage of Participants With Virologic Failure	Virologic failure was defined as: On-treatment virologic failure: 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); Virologic relapse: Confirmed HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.	Up to Posttreatment Week 24