Hepatic Safety and Tolerability of Raltegravir among HIV Patients Coinfected with Hepatitis B And/Or C

Abstract

Background Potential liver toxicity is an important consideration for antiretroviral selection among patients coinfected with HIV and viral hepatitis (B and/or C). We sought to describe the hepatic safety profile of raltegravir in this population. Methods Using data from HIV clinical cohorts at Johns Hopkins University and the University of North Carolina at Chapel Hill, we evaluated factors associated with liver enzyme elevations (LEEs) and calculated adverse event incidence rates for patients initiated on raltegravir-containing regimens prior to January 1, 2010. LEEs were graded according to Division of AIDS definitions. Results During the study period, 456 patients received raltegravir – of whom 36% were hepatitis-coinfected (138 HCV, 17 HBV, 11 HBV+HCV). Coinfected patients were more likely to have baseline abnormal LEEs, and developed severe (grade 3–4) LEEs at a rate 3.4 times that of HIV-monoinfected patients (95% confidence interval (CI), 1.28, 9.61). Among all participants, the incidence rate for first occurrence of severe LEEs was 5 per 100 person-years (95% CI, 3, 7). In adjusted analyses, coinfected patients had a 2.7-fold increased hazard of severe LEEs (95% CI, 1.03, 7.04). Sixty percent of severe abnormalities occurred within 6 months after starting raltegravir; the drug was discontinued in 3 coinfected patients (1.3%) and 18 monoinfected patients (6.2%). Conclusions Compared to HIV-monoinfected patients, those with HIV-hepatitis coinfection are at increased hazard of developing LEEs on raltegravir, at a level similar to other antiretrovirals. Severe events were uncommon, rarely leading to raltegravir discontinuation. With appropriate monitoring, raltegravir-based therapy is safe in hepatitis-coinfected patients.

HIV-hepatitis B virus coinfection

“…Liver enzyme elevations were again more common in coinfected individuals, however clinical sequelae were not seen, and there was no difference in efficacy in terms of HIV suppression between RAL and control groups. Similar results were seen in subsequent observational studies including over 150 individuals commenced on RAL, coinfected with either HCV or HBV [182] .…”

Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Co-infection among HIV infected individuals at tertiary care hospital in western Nepal

“…It is estimated that one third of deaths in HIV patients are directly or indirectly related to liver diseases [1]. Compared to HIV-mono-infected patients, HIV-hepatitis co-infection are at increased risk of developing liver enzyme elevations on antiretroviral therapy [13]. Failure to diagnose and treat co-infection at an early stage results in serious complications and sequelae.…”

“…The derangement of liver functions as a result of ART or opportunistic infections may also complicate the situation. Compared to HIV-mono-infected patients, those with HIV-hepatitis co-infection are at increased hazard of developing liver enzyme elevations on antiretroviral [13]. Hepatitis viruses in HIV may lead to faster progression to liver cirrhosis and a higher risk of antiretroviral therapy induced hepatotoxicity.…”

Liver Toxicity of Current Antiretroviral Regimens in HIV-Infected Patients with Chronic Viral Hepatitis in a Real-Life Setting: The HEPAVIR SEG-HEP Cohort

“…Data on the current rates of TE observed among HIV-infected patients with hepatitis virus coinfection obtained in the clinical practice have been described within different cohorts [ 1 , 3 – 5 , 13 – 20 ]. However, most of these studies have a retrospective design.…”