GS-US-334-0124 Phase 3 Hep C/HIV Study (PHOTON 2)

• Research type

  Research Study

• Full title

  A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects

• IRAS ID

  118142

• Contact name

  Chloe Orkin

• Sponsor organisation

  Gilead Sciences Inc

• Eudract number

  2012-004154-28

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Hepatitis C virus (HCV) infection affects an estimated 180 million people globally. There are 6 major types of HCV called genotypes. The genotype is the specific genetic makeup of the virus within an individual, usually in the form of DNA. The most common genotype in the USA and Europe is genotype 1 followed by genotype 2 and genotype 3. Genotype 4, 5 and 6 is most common in the Middle East, South Africa and Southeast Asia, respectively. About 1/3 of HIV-positive patients are co-infected with the HCV. This is a phase 3 open-label study in patients with Genotype 1, 2 3 and 4 co-infected with Hepatitis C and HIV. Approximately 220 patients at about 45 sites in Australia, France, Germany, Italy, Portugal, Spain and the United Kingdom will be taking part. The purpose of the study is to investigate the effectiveness and safety of treatment with Sofosbuvir (SOF) plus Ribavirin (RBV). Participants will be enrolled in 1 of 3 treatment arms based on treatment and disease history: 1) Arm 1: 50 patients with Genotype 2 and 3 who have never received treatment for their illness will receive 12 weeks of treatment with SOF (400 mg once daily) and RBV (1000-1200 mg daily) 2) Arm 2: 50 patients with Genotype 2 and 3 who have received prior treatment for their illness will receive 24 weeks of treatment with SOF (400 mg once daily) and RBV (1000-1200 mg once daily) 3) Arm 3: 100 patients with Genotype 1 and approximately 20 patients with Genotype 4 who have never received treatment for their illness will receive 24 weeks of treatment with SOF (400 mg once daily) and RBV (1000-1200 mg daily) All participants will know which treatment they will be receiving and will be in the study for approximately 40 or 52 weeks depending on which treatment they receive: ?½ 28 day (4 week) screening period ?½ 12 or 24 week treatment period ?½ Up to 24 week post-treatment period

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  13/LO/0006

• Date of REC Opinion

  18 Jan 2013

• REC opinion

  Favourable Opinion