(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
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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Provisional Program (at 18 February 2009) 0800-0930 AOFOG Executive Meeting Venue: 1000-1700 AOFOG Council Meeting Venue: Marlborough Room 2 1200-2130 Registration Desk Open 1800-2000 Opening Ceremony Venue: New Zealand Room 2000-2130 Welcome Reception Venue: Trade Exhibition Breakfast Sessions – Meet the experts 0800-0900 B1: Antenatal scr