The study is based in Pakistan with our Collaborators (Aga Khan University, Dow University, the Liver Clinic, Gujranwala and Dr Huma Qureshi's Clinic, Karachi) in Pakistan and colleagues at Oxford University and Bristol University. It comprises a screening study and a second-line treatment study.
Aims of the Screening study
- To establish the rate of virus clearance (known as sustained virological response; SVR) in people with HCV in Pakistan treated with first-line anti-viral drugs (sofosbuvir plus daclatasvir).
- Measure the annual incidence of new HCV infections in uninfected people and those that have been cured of HCV infection.
- Assess the cost-effectiveness of treating HCV infections in Pakistan (looking at rates of response and re-infections).
- Establishing the type and frequency of HCV resistance associated variants in Pakistan and their impact upon response to first-line treatments.
- Examine the type and frequency of HCV genetic variants in Pakistan that are associated with HCC in people who do and do not have liver cancer.
Aims of the Second-line treatment study
- Determine whether an extended regime of sofosbuvir plus velpatasvir (for 24 weeks) is clinically superior to the usual regime of sofosbuvir plus velpatasvir (for 12 weeks), in people with chronic hepatitis C infection who have not responded to first line therapy with sofosbuvir plus daclatasvir, with or without ribavirin.
- Assess whether therapy with sofosbuvir plus velpatasvir for 24 weeks versus 12 weeks is cost effective in the treatment of people with chronic hepatitis C infection who have not responded to first line therapy with sofosbuvir plus daclatasvir, with or without ribavirin.
- To determine the efficacy of 24 weeks sofosbuvir plus velpatasvir in an observational cohort of up to 50 patients with decompensated cirrhosis (where your liver is having trouble functioning).