Conclusions

• RAL was efficacious in HIV-infected patients with and without Hepatitis B and/or Hepatitis C co-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). 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 al