HCV Treatment in HIV Co-Infected Patients in Asia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 proportion of patients with sustained virological response (SVR), defined as an undetectable HCV RNA, 24 weeks after completion of therapy [ Time Frame: 24 weeks after completion of therapy ] [ Designated as safety issue: No ]
- Proportion of patients with Rapid Virological Response (RVR) [ Time Frame: 4 weeks of therapy ] [ Designated as safety issue: No ]
- Proportion of patients with Early Virological Response (EVR) [ Time Frame: 12 weeks of therapy ] [ Designated as safety issue: No ]
- Proportion of patients with End of Treatment Response (ETR) [ Time Frame: Up to 48 weeks of therapy ] [ Designated as safety issue: No ]
- Proportions of patients who discontinue treatment prematurely [ Time Frame: Up to 48 weeks of therapy ] [ Designated as safety issue: Yes ]
- Clinical and laboratory safety parameters [ Time Frame: Up to 48 weeks of therapy ] [ Designated as safety issue: Yes ]The proportion of participants with all grades of adverse events will be summarized by severity and relation to study drugs.
|Study Start Date:||December 2013|
|Study Completion Date:||September 2016|
|Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Pegylated-Interferon and Ribavirin
Pegylated-interferon 1.5 microgr/kg, subcutaneously, once weekly for 48 weeks*. Ribavirin, weight-based dosage, divided in two daily doses for 48 weeks*.
*patients with genotype 2 and 3, moderate liver fibrosis, and rapid virologic response will receive therapy for 24 weeks.
Drug: Pegylated-Interferon and Ribavirin
This is an open-label, single arm demonstration study. Intervention consists in treatment with Pegylated-interferon (Peg-Intron®, 1.5 microgr/kg/week, as subcutaneous injection) and ribavirin (Rebetol®, weight-based dosing, 2-daily doses) for 48 weeks, or 24 weeks for patients with genotype 2 and 3, moderate liver fibrosis, and rapid virological response.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01838772
|Cipto Mangunkusumo General Hospital|
|Jakarta, Indonesia, 10430|
|University of Malaya Medical Centre|
|Kuala Lumpur, Malaysia, 59100|
|HIV-NAT/ Thai Red Cross AIDS Research Center|
|Bangkok, Thailand, 10330|
|National Hospital for Tropical Diseases|
|Principal Investigator:||Nicolas Durier, MD, MPH||TREAT Asia/ amfAR - The Foundation for AIDS Research|
|Principal Investigator:||Gail Matthews, MD, PhD||The Kirby Institute, University of New South Wales|