Health TrialsbyHealthPanel

Treating Hepatitis C in Pakistan. Strategies to Avoid Resistance to Antiviral Drugs

ConditionHepatitis C, Chronic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorQueen Mary University of London

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Unwilling to give consent

Unwilling or unable to undergo the necessary procedures

Clinically significant illness (other than HCV) or other major medical condition that may interfere with the subject's treatment, assessment or compliance with protocol.

Co-morbidities limiting life expectancy to less than 12 months

Trial population

Recruitment of uninfected and infected people will be from two provinces in Pakistan (Sindh and Punjab) where there is a high prevalence of HCV. Recruitment will reflect the community sample.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • HCV RNA (PCR)

    Diagnostic test

    We will test HCV positive patients after treatment to observe if they achieve SVR

  • HCV Antibody test (Point of care)

    Diagnostic test

    HCV antibody test used to establish if patients have had or are actively infected with HCV

  • AST/ALT and platelets measurement

    Diagnostic test

    AST/ALT and platelets to determine APRI score

Treatment groups

25,000 Participants
are divided into 4 treatment groups
Group A: HCV Negative1 intervention
Group B: HCV Positive with first-line treatment success1 intervention
Group C: HCV positive with first-line treatment failure1 intervention
Group D: Cirrhotic Patients1 intervention

Trial outcomes

Primary outcomes

1

SVR

After first-line treatment, SVR will be measured to record treatment failure or success

Time frame
12 weeks after treatment completion
2

Incidence of new infections

Measure HCV antibodies in people who initially tested HCV antibody negative at screening.

Time frame
12 months after screening
3

Incidence of re-infection

In patients who achieved an SVR after first-line treatment will then be tested for HCV core antigen over 12 months.

Time frame
12 months after first SVR test.

Secondary outcomes

1

Health related Quality of Life

Determined by an EQ-5D-3L questionnaire in 200 HCV positives and at least 1000 negatives and 50 cirrhotic patients

Time frame
Screening stage
2

Health care costs and productivity assessment associated with HCV infection

Questionnaires in 200 HCV positives and at least 1000

Time frame
screening stage
3

Risk assessment

Assess risk factors using questionnaires for HCV infection in 200 HCV positives and at least 1000. Then after 12months in HCV negatives

Time frame
12 months
4

Viral polymorphisms in HCV

Investigating the frequencies in people who respond to therapy compared with those who do not achieve SVR Identified using whole viral genome sequencing in all patients who do not respond to therapy and age, gender and liver disease matched controls

Time frame
2 years

Other outcomes

Sponsors and contacts

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Queen Mary University of London

Lead sponsor

Aga Khan University

Collaborator

Dow University of Health Sciences

Collaborator

University of Oxford

Collaborator

University of Bristol

Collaborator

Source ClinicalTrials.gov
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