Premium
Safety and efficacy of raltegravir in patients with HIV‐1 and hepatitis B and/or C virus coinfection
Author(s) -
Rockstroh JK,
Teppler H,
Zhao J,
Sklar P,
Harvey CM,
Strohmaier KM,
Leavitt RY,
Nguyen BYT
Publication year - 2012
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/j.1468-1293.2011.00933.x
Subject(s) - raltegravir , medicine , coinfection , emtricitabine , efavirenz , hepatitis b virus , lamivudine , virology , gastroenterology , adverse effect , hepatitis c virus , hepatitis b , viral load , virus , antiretroviral therapy
ObjectiveThe aim was to examine the long‐term safety and efficacy of raltegravir in patients with HIV‐1 and hepatitis B virus (HBV) and/or hepatitis C virus (HCV) coinfection in three double‐blind, randomized, controlled Phase III studies.MethodsIn STARTMRK, treatment‐naïve patients received raltegravir 400 mg twice a day (bid) or efavirenz 600 mg at bedtime, both with tenofovir/emtricitabine. In BENCHMRK‐1 and ‐2, highly treatment‐experienced patients with multi‐drug resistant virus and prior treatment failure received raltegravir 400 mg bid or placebo, both with optimized background therapy. Patients with chronic HBV and/or HCV coinfection were enrolled if baseline liver function tests were ≤5 times the upper limit of normal. HBV infection was defined as HBV surface antigen positivity for all studies; HCV infection was defined as HCV RNA positivity for STARTMRK and HCV antibody positivity for BENCHMRK.ResultsHepatitis coinfection was present in 6% (34 of 563) of treatment‐naïve patients (4% HBV only, 2% HCV only and 0.2% HBV+HCV) and 16% (114 of 699) of treatment‐experienced patients (6% HBV only, 9% HCV only and 1% HBV+HCV). The incidence of drug‐related adverse events was similar in raltegravir recipients with and without hepatitis coinfection in both STARTMRK (50 vs . 47%) and BENCHMRK (34 vs . 38.5%). Grade 2–4 liver enzyme elevations were more frequent in coinfected vs . monoinfected patients, but were not different between the raltegravir and control groups. At week 96, the proportion of raltegravir recipients with HIV RNA <50 HIV‐1 RNA copies/mL was similar between coinfected and monoinfected patients (93 vs . 90% in STARTMRK; 63 vs . 61% in BENCHMRK).ConclusionRaltegravir was generally well tolerated and efficacious up to 96 weeks in HIV‐infected patients with HBV/HCV coinfection.