|
|
Abstract
Hepatotoxicity in injection drug users (IDUs) and non-IDUs receiving nevirapine-based HAART
H. Tossonian1, J. Raffa2, J. Grebely1, C. Hofmann1, A. Mistry1, A. Winther1, M. Viljoen3, S. DeVlaming3, B. Conway1
Background: Hepatotoxicity is a frequent cause of interruption of antiretroviral therapy especially in IDUs co-infected with HCV. We have measured the incidence of hepatotoxicity in IDUs receiving HAART and its effect on treatment outcome and compared these parameters to those measured on non-IDUs.
Methods: HIV-infected IDUs and non-IDUs initiating nevirapine-based HAART (along with 2 NRTIs) as the first NNRTI-based regimen were included in this retrospective, comparative study. ALT and AST levels were evaluated at baseline and at months 1, 3, 6, 9 & 12, hepatotoxicity being defined as a single value > 5x ULN (grade 3 or 4 toxicity).
Results: A total of 162 subjects (80 IDUs, 54 males; 82 non-IDUs, 76 males) were included in the analysis. At entry, 32% of patients were drug-naïve, with 94% IDUs and 30% non-IDUs being HCV-positive. Grade 3/4 ALT and AST elevations at any time point were 11% and 13% in IDUs and 13% and 9% in non-IDUs, respectively (p>0.05 for all comparisons). Cumulative treatment discontinuation rate at month 12 due to hepatotoxicity was 9% in IDUs and 9% in non-IDUs with no deaths due to hepatic failure registered during this period. Using a Cox Proportional Hazard model, > grade 2 hepatotoxic events were associated with HCV-infection (HR=9.0, 95% CI: 2.5-33.3, p<0.001), being naïve to HIV therapy (HR=3.7, 95% CI: 1.5-9.2, p=0.005), and having baseline ALT >ULN (HR=3.8, 95% CI: 1.0-13.5, p=0.04). When adjusting for these risk factors, IDUs were less likely to experience grade 3/4 hepatotoxicity (HR=0.2, 95% CI: 0.07-0.57, p=0.002).
Conclusions: Clinically significant hepatotoxicity occurred in 15% IDUs and 15% non-IDUs. HCV-infection, being naive to HAART and abnormal baseline ALT were associated with higher risk of hepatotoxicity. Application of these criteria will allow us to define a population of IDUs and non-IDUs in whom nevirapine-based therapy can be safely prescribed.
AIDS 2006 - XVI International AIDS Conference
Abstract no.
WEPE0176
Suggested Citation
"H.Tossonian, et al.
Hepatotoxicity in injection drug users (IDUs) and non-IDUs receiving nevirapine-based HAART.
:
AIDS 2006 - XVI International AIDS Conference:
Abstract no.
WEPE0176"
|
|
|