HIV Clinical Trial
Official title:
Effectiveness and Tolerability of Hepatitis C Treatment in HIV Co-infected Patients in Routine Care Services in Asia: A Pilot Model of Care Project
The purpose of this study is to assess the effectiveness and tolerability of hepatitis C virus (HCV) treatment in HIV co-infected patients in routine health care services in Asia through a pilot model of care for treatment of HCV in resource-limited settings.
It is estimated that 130-170 million people are chronically infected with the hepatitis C
virus (HCV). Out of the 33 million HIV-infected people around the world, it is estimated
that at least 5 million are also infected with HCV. HCV therapy with Pegylated-interferon
and ribavirin is between 50-90% effective to achieve cure, depending on the virus genotype
and patient characteristics, such as ethnicity and IL28B polymorphism. Treatment studies in
HIV-uninfected populations have shown that Asian patients experience higher treatment
response rates than Caucasians. Unfortunately, although HCV therapy is routinely offered in
resource-rich settings, it is essentially inaccessible in resource-limited settings (RLS),
where most of the people infected with the virus live. One of the bottlenecks to increasing
implementation of HCV therapy in RLS is that therapy is currently expensive and deemed
complex for broad implementation in RLS. Through this project and study, TREAT Asia aims to
build a regional approach in Asia to establish the feasibility of HCV therapy in
HIV-infected patients in RLS, and implement an innovative model of HCV-HIV care that can be
expanded in the future.
Patients with HIV infection and documented HCV antibodies under routine HIV care at the four
study sites will have HCV RNA testing. Patients with confirmed chronic HCV infection will
have HCV genotype and IL28B testing, as well as liver disease assessment with Fibroscan®.
Patients with chronic HCV co-infection with any genotype and meeting all other treatment
eligibility criteria will be offered treatment with pegylated-interferon and ribavirin
through an open-label single arm study. A total of up to 200 patients will be enrolled into
the study. Patients will receive intensive treatment preparedness counseling, and ongoing
treatment adherence support. Most patients will receive treatment for a total of 48 weeks,
but patients with HCV genotype 2 and 3, moderate liver fibrosis, and rapid virological
response (negative HCV RNA by four weeks of therapy) will receive 24 weeks of therapy. The
primary endpoint of interest will be the proportion of patients achieving sustained
virological response, defined as an undetectable HCV RNA 24 weeks after treatment
completion.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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