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Hepatic Safety & Efficacy of Raltegravir in Patients Co-infected with HIV and Hepatitis B (HBV) and/or C (HCV) Virus
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Reported by Jules Levin
CROI 2010 Feb 16-19 SF
Jurgen Rockstroh1, Hedy Teppler2, Jing Zhao2, Peter Sklar2, Charlotte Harvey2, Randi Leavitt2, and Bach-Yen Nguyen2
1University of Bonn, Bonn-Venusberg, Germany; 2Merck Research Laboratories, West Point, PA, USA
AUTHOR CONCLUSIONS
RAL was efficacious in HIV-infected patients with and without Hepatitis B and/or Hepatitis Cco-infection.
RAL was generally well tolerated in HIV-infected patients with and without Hepatitis B and/or Hepatitis C co-infection.
- Grade 2, 3, 4 liver enzyme elevations were observed more frequently in HIV/HBV/HCV co-infected patients than in HIV-monoinfected patients, but this difference was noted in both the RAL and control groups (EFV in STARTMRK and OBT in BENCHMRK-1 & 2).
ABSTRACT
Objective: This analysis reports long-term hepatic safety and efficacy data from patients (pts) with HBV and/or HCV co-infection who participated in 3 Phase III studies of raltegravir (RAL).
Methods: Each study was double-blind and randomized. In STARTMRK, treatment-naïve pts received RAL 400 mg bid or efavirenz (EFV) 600 mg qhs, both in combination with tenofovir/emtricitabine (TDF/FTC). In BENCHMRK-1 and -2, highly treatment-experienced pts with multi-drug resistant virus failing other therapies received RAL 400 mg bid or placebo, both in combination with optimized background therapy (OBT). Pts with chronic (but not acute) active HBV and/or HCV co-infection were permitted to enroll, provided that baseline liver function tests did not exceed 5 times the upper limit of normal. HBV infection was defined as + Hepatitis B surface antigen for all studies; HCV infection was defined as + HCV RNA for STARTMRK and as + Hepatitis C antibody for BENCHMRK.
Results: In total, 743 pts received RAL and 519 received comparator across the 3 studies. Hepatitis co-infection was present in 16% (114/699) of treatment-experienced pts (HBV=6 %, HCV=9 %, HBV+HCV=1 %) and in 6% (34/563) of treatment-naïve pts (HBV=4 %, HCV=2 %, HBV+HCV=0.2 %). Selected safety and efficacy results at week 96 are shown for pts with (+) HBV/HCV and those without (-) HBV/HCV co-infection.
* Exposure-adjusted rates per 100 patient-years at risk (PYR) are shown for the BENCHMRK studies, due to longer duration of exposure in the RAL group.
** Observed failure approach.
Conclusion: Grade 3,4 liver enzyme elevations were observed more frequently in HIV/HBV/HCV co-infected patients than in HIV-monoinfected patients, but were not different between the raltegravir and control (OBT or EFV) groups. Overall, raltegravir was efficacious and generally well tolerated to 96 weeks in HIV-infected patients with HBV and/or HCV co-infection.
BACKGROUND
Overall Efficacy through Week 96
Proportion (%) of Patients (95% CI) with HIV RNA <50 copies/mL (Non-Completer = Failure)
Change from Baseline in CD4 Cell Count
(Observed Failure)
RESULTS
Baseline Patient Characteristics
Efficacy at Week 96 by Hepatitis Co-infection Status
Safety by Hepatitis Co-infection Status
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