Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection

PHASE3CompletedINTERVENTIONAL
Enrollment

687

Participants

Timeline

Start Date

December 10, 2013

Primary Completion Date

August 12, 2016

Study Completion Date

November 3, 2016

Conditions
Chronic HCV Infection
Interventions
DRUG

Sofosbuvir

Sofosbuvir 400 mg tablet administered orally once daily

DRUG

RBV

Ribavirin (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)

DRUG

PEG

Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week

Trial Locations (35)

Unknown

Beijing

Chongqing

Fujian

Guangdong

Guangxi

Hainan

Hebei

Hubei

Hunan

Jiangxi

Jilin

Jin’an

Liaoyang

Shanghai

Sichuan

Yunnan

Zhejiang

Hong Kong

Shatin

Incheon

Seongnam-si

Ansan-si

Bucheon-si

Busan

Daegu

Seoul

Chang-hua

Kaohsiung City

Keelung

Taichung

Tainan City

Taipei

Taoyuan District

Hanoi

Ho Chi Minh City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY