(Clinician Summary Sheet)
A Prospective, Phase III, Open-Label Study of Boceprevir, Pegylated-Interferon Alfa 2b
and Ribavirin in HCV/HIV Coinfected Subjects (BIRTH)
A Multicenter Trial of the Aids Clinical Trials Group (ACTG)
Prospective, phase III, open-label, single-arm study of pegylated-interferon alfa 2b
(PEG- IFN), ribavirin (RBV), and boceprevir (BOC), with a PEG-IFN + RBV
lead-in phase, in hepatitis C virus (HCV) treatment-naïve (Group A) and HCV treatment
-experienced (Group B) genotype 1 HCV/HIV-1 coinfected subjects. Purpose of this Study:
We hypothesize that addition of BOC to the current standard-of-care regimen (PEG-IFN + RBV)
will improve HCV treatment efficacy in HCV genotype 1-infected subjects with HCV/HIV-1
coinfection. Sustained virologic response (SVR) rates for HCV are lower among HCV/HIV-1
coinfected individuals compared to HCV-mono infected persons. Addition of novel HCV
protease inhibitors to PEG-IFN and RBV has been shown to improve SVR significantly among
HCV- mono infected persons, and holds promise in the HCV/HIV-1 coinfected population.
Currently, there are no published phase III studies of PEG-IFN + RBV + BOC in HCV/HIV-1
coinfected subjects, providing strong rationale to conduct this pivotal, phase III trial in this
population. Requirements to Enter Study:
Group A (Step 1)
Never received treatment for HCV with standard interferon or pegylated-interferon, or
experimental agents used to treat HCV, with or without RBV.
Group A (Step 2)
Completion of step 1 and no demonstration of HCV virologic/treatment failure.
Received any treatment with standard interferon or pegylated-interferon with or without RBV at
any time provided the last dose of such treatment was ≥ 90 days prior to study entry.
Groups A and B
- Documented HIV infection and ≥18 years of age
- Presence of chronic HCV infection with a positive HCV RNA ≥ 180 days ago and current
HCV viremia or a positive liver biopsy or HCV FibroSURE™ test demonstrating chronic
- HCV RNA ≥10,000 copies within 42 days prior to study entry and screening genotype 1 performed within 6 months prior to study entry - Viral load < 50,000 copies for subjects not on ART and viral load < 50 copies for subjects on ART and T-cell count >200 cells within 42 days prior to study entry
- Either a liver biopsy or HCV FibroSURE™ test obtained within 104 weeks prior to study entry - Currently not on any ART for at least 4 weeks immediately prior to entry or on stable ART for at least 8 weeks prior to study entry using a dual NRTI backbone PLUS one of the following: EFV, RAL, LPV/RTV 400/100mg BID, ATV/RTV, DRV/RTV 600/100mg BID - Safety labs - No active depression or uncontrolled mental health disorders
Group A (HCV Treatment-Naïve)
Step 1: All subjects will undergo a lead-in phase in which they will receive PEG-IFN + RBV for 4
weeks. BOC will then be added to the PEG-IFN + RBV regimen for an additional 24 wks.
Step 2: At week 28, subjects without cirrhosis at study screening who have undetectable week 8 HCV RNA and are still on study treatment will discontinue study treatment, while subjects without cirrhosis at study screening who have detectable week 8 HCV RNA or missing week 8 HCV RNA who are still on study treatment will continue on PEG-IFN + RBV + BOC for an additional 8 wks (to week 36), followed by PEG-IFN + RBV for an additional 12 wks (total study treatment duration of 48 weeks). At week 28, subjects with cirrhosis at study screening will continue on PEG-IFN + RBV + BOC for an additional 20 wks (total study treatment duration of 48 wks), ie, they will receive 4-week lead-in with PEG-IFN + RBV followed by 44 weeks of triple therapy with PEG-IFN + RBV + BOC.
Group B (HCV Treatment-experienced)
Subjects will undergo a lead-in treatment phase in which they will receive PEG-IFN + RBV for 4
weeks. After the lead-in phase, subjects without cirrhosis at study screening will receive PEG-
IFN + RBV + BOC for 32 weeks, followed by PEG-IFN + RBV alone for an additional 12 weeks.
After the lead-in phase, subjects with cirrhosis at study screening will receive 44 weeks of PEG-
IFN + RBV with BOC. The total duration of study treatment in Group B is 48 weeks. Duration of Study:
72 weeks For more information contact:
Ericka R. Patrick, RN, MSN
A5294 Study Coordinator
341 Ponce de Leon Ave. NE
Atlanta, GA 30308
404-616-9702-fax [email protected]
Please remember to obtain local IRB approval prior to the distribution of any
protocol-specific information including study specific recruitment tools developed for providers and
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