Treating Hepatitis C in Pakistan. Strategies to Avoid Resistance to Antiviral Drugs
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY
We will determine how best to manage the hepatitis C virus (HCV) epidemic in Pakistan by measuring effectiveness of Pakistan-government sponsored current therapies, emergence of viral resistance, consequences of infection (chiefly liver cancer) and through developing models, based on incidence data, determine the proportion of people who need curative treatment to eliminate HCV, and assess whether targeting can optimise this.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: t
View:
• Adults over 18yrs old
• Willing to undergo hepatitis C testing
• Able and willing to give informed consent
• Willing to return in 12 months time for repeat testing
• Resident in area and not planning to leave the region
Locations
Other Locations
Pakistan
Aga Khan University
RECRUITING
Karachi
Contact Information
Primary
Graham R Foster, MBBS
g.r.foster@qmul.ac.uk
07968836267
Backup
Naheed Choudhry, Phd
naheedchoudhry1@gmail.com
07951160549
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 25000
Treatments
HCV Negative
At initial screen, this population will be HCV negative via the diagnostic testing. They will be eligible if they fulfil the following:~1. over 18 yrs old.~2. willing to participate~3. no previous history of therapy with oral medication for chronic HCV infection
HCV Positive with first-line treatment success
At the initial screen, this population (approx. 5000) will be HCV RNA positive and will undergo 12/24 week treatment of sofosbuvir plus daclatasvir. After treatment, their blood sample will show that they have achieved a sustained virological response (SVR) defined as HCV RNA undetectable.
HCV positive with first-line treatment failure
At the initial screen, this population (approx. 5000) will be HCV RNA positive and will undergo 12/24 week treatment of sofosbuvir/daclatasvir. After treatment, this proportion of people will NOT achieve an (SVR - defined as HCV RNA undetectable).
Cirrhotic Patients
Hepatitis C RNA positive that have cirrhosis
Related Therapeutic Areas
Sponsors
Collaborators: Dow University of Health Sciences, Aga Khan University, University of Bristol, University of Oxford
Leads: Queen Mary University of London