Raltegravir-based therapy in a cohort of HIV/HCV co-infected individuals

The relationship between hepatic tolerance and hepatitis C virus (HCV)
co-infection has not been extensively studied in clinical practice. We assessed
the efficacy and safety of raltegravir-based therapy in an Italian cohort of
HIV/HCV co-infected patients. One hundred and forty patients with HIV/HCV
co-infection initiating raltegravir from SCOLTA project (Surveillance Cohort
Long-Term Toxicity Antiretrovirals) were examined. Of them, 43 were women, with
mean age of 45.4±6.4years; 65 (46%) had undetectable HIV-RNA<50copies/mL and 75
(54%) HIV-RNA≥50copies/mL. According to CDC classification, 49 (35%) were in
stage C. Based on Fib4 score at the time of starting raltegravir, patients were
classified in class I in 41 cases, class II in 68 and in class III in 31 cases.
Globally, the Fib4 score slightly decreased during 24months follow-up, from 2.2
to a value of 1.8. Hepatic adverse events of any grade were observed in 67
patients, of which only 2 cases (3%) had severe liver toxicity (grade 3-4). Only
one patient had to discontinue the therapy because of adverse events. According
to univariate analysis, being in CDC stage C represented a risk for the
development of liver toxicity, with a hazard ratio (HR) of 2.27 (95% CI
1.06-4.84, P=0.033). None of the other variables considered (age, sex, years
since detection of HIV and HCV-RNA detectable, years of previous HIV therapy,
concomitant therapy with PI or NRTI, CD4+ cell count, Fib4, and transaminases
level at baseline) resulted statistically correlated to the outcome. In
conclusion, raltegravir-based regimens can be safely used in HCV infected
patients; in this study, the hepatic toxicity has been found to be more frequent
in patients with an advanced HIV disease (CDC stage C), independently of HIV-RNA
suppression at raltegravir initiation.