SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection

Hepatitis C Clinical Trial

Official title:

A Phase 3B Randomized, Open-Label, Multi-Center Trial Assessing Sofosbuvir + Ribavirin for 16 or 24 Weeks and Sofosbuvir + Pegylated Interferon + Ribavirin for 12 Weeks in Subjects With Genotype 2 or 3 Chronic HCV Infection.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01962441
• Other study ID #: GS-US-334-0153
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 10, 2013
• Last updated: January 7, 2016
• Start date: September 2013
• Est. completion date: June 2016

Study information

• Verified date: January 2016
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNew Zealand: MedsafeCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+peginterferon alfa-2a (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 601
• Est. completion date: June 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female, age greater than or equal to 18 years.

• Confirmed chronic HCV infection.

• Subjects will have cirrhosis status assessment; liver biopsy may be required.

• Genotype 2 subjects must have cirrhosis of the liver to be eligible.

• Treatment-naive or prior treatment failure to =12 weeks of an interferon- based regimen that was not discontinued prematurely due to an adverse event

• Infection with HCV genotype 2 or 3 as determined at Screening

• Body mass index (BMI) greater than or equal to 18 kg/m^2

• Screening laboratory values within predefined thresholds.

• Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC.

• Subject must be of generally good health as determined by the Investigator.

Exclusion Criteria:

• Prior use of any other inhibitor of the HCV nonstructural protein (NS)5B polymerase

• Pregnant or nursing female or male with pregnant female partner

• History of any other clinically significant chronic liver disease.

• HIV or chronic hepatitis B virus (HBV) infection.

• Malignancy with the exception of certain resolved skin cancers.

• Chronic use of systemically administered immunosuppressive agents.

• Clinically-relevant drug or alcohol abuse.

• History of solid organ transplantation.

• Current or prior history of clinical hepatic decompensation.

• History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.

• Known hypersensitivity to interferon, RBV, the study investigational medicinal product, the metabolites, or formulation excipients.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• SOF
SOF 400 mg tablet administered orally once daily
• RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and = 75 kg = 1200 mg)
• Peg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Canada,  New Zealand,  United Kingdom, 

References & Publications (1)

Foster GR, Pianko S, Brown A, Forton D, Nahass RG, George J, Barnes E, Brainard DM, Massetto B, Lin M, Han B, McHutchison JG, Subramanian GM, Cooper C, Agarwal K; BOSON Study Group. Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa — View Citation

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	No
Primary	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event		Up to 24 weeks	No
Secondary	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.	Posttreatment Weeks 4 and 24	No
Secondary	Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24		Weeks 1, 2, 4, 8, 12, 16, 20, and 24	No
Secondary	HCV RNA at Weeks 1, 2, 4, 8, and 12		Weeks 1, 2, 4, 8, and 12	No
Secondary	Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12		Baseline; Weeks 1, 2, 4, 8, and 12	No
Secondary	Percentage of Participants Experiencing On-Treatment Virologic Failure	On-treatment 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)	Up to 24 weeks	No
Secondary	Percentage of Participants Experiencing Viral Relapse	Viral relapse is defined as 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	No