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Meds and Liver Toxicity

Nov 18, 2003

Dr Young

I received this article on the Lipo support group site. Do you know that all this means? Is the chance of getting liver toxicity fairly high, even for those who are hep. neg

Predictors of Antiretroviral-related Severe Liver Toxicity in 21 AACTG Studies

The use of antiretroviral therapy (ART) for HIV has been associated with severe, grade 3+ hepatotoxicity (SH), liver failure and death. Researchers at Massachusetts General Hospital previously presented results from our retrospective analysis on the incidence of SH and mortality in 21 Adult AIDS Clinical Trials Group (AACTG) studies.

The studies enrolled subjects into arms that included single and multiple nucleoside reverse transcriptase inhibitors (NRTI), and triple drug regimens that included varying combinations of NRTIs, non-nucleoside reverse transcriptase inhibitors (NNRTI), and protease inhibitors (PI). (Gastroenterology 2001; 120: A54.).

The investigators found that 10 of subjects developed SH (AST, ALT, total bilirubin > 5xULN) in all treatment regimens (12 single NRTI, 7.9 multiple NRTIs, 8.6 PI (-) triple drug, 12 PI (+) triple drug).

The overall and liver-related death rates were 15 and 0.3, respectively.

Factors associated with SH were not included in our initial analysis. This report identifies baseline predictors for SH in those receiving single NRTI, multiple NRTI, NNRTI, and PI-based regimens.

9,017 subjects were analyzed. Stepwise, multi-covariate, logistic regression was used to determine baseline factors associated with the development of SH occurring in the first 6 and 6-12 months of single NRTI, multiple NRTI, NNRTI, and PI therapy.

ART included: NRTIs AZT, ddI, ddC, d4T, and 3TC; NNRTIs nevirapine (NVP) and delavirdine; and the PI indinavir. Baseline factors included age, gender, ethnicity, history of intravenous drug use (IVDU), ART, entry CD4+ < 300 cells/mm3, hepatotoxic potential of concomitant medications (CMEDS), concomitant medical problems at entry, and baseline laboratory values (AST, ALT, total bilirubin (TB), hemoglobin, WBC, absolute neutrophil count, creatinine, platelet count (plt), cholesterol, triglyceride, and glucose).

Baseline hepatitis B and C status were not determined.

Response from Dr. Young

Thanks for your post--

on the contrary, as I read what you've included, this study showed that only 10 of over 9000 patients enrolled in these many studies developed severe liver toxicity. This is a rate of about 0.1% of subjects, or one in a thousand. BY

15 years?
fatigue after meds

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