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Patients infected with the human immunodeficiency virus (HIV) that causes AIDS are increasingly prescribed antiretroviral regimens, which include HIV-1-specific non-nucleoside analog reverse transcriptase inhibitors (NNRTIs), such as nevirapine (NVP) and efavirenz (EFV). Recently, these medications have been found to be associated with severe liver injury.
According to a new study, severe liver toxicity was more common among NNRTI patients prescribed NVP, those coinfected with hepatitis B virus and hepatitis C virus, and those who also received protease inhibitors. Severe liver toxicity didn't appear until after the first 12 weeks of therapy. Thus, doctors should frequently monitor liver enzymes after starting a patient on antiretroviral therapy and continue the monitoring throughout the treatment period, according to the Johns Hopkins' researchers who conducted the study. Their work was supported in part by the Agency for Healthcare Research and Quality (HS07809).
The researchers prospectively studied the incidence of severe liver toxicity (grade 3 or 4 change in alanine or aspartate transaminase levels) among 568 patients receiving NNRTI-containing antiretroviral therapy, including 312 and 256 patients prescribed EFV and NVP, respectively. They detected hepatitis C virus in 43 percent of patients and hepatitis B virus in nearly 8 percent of patients. Nearly 16 percent of patients prescribed NVP and 8 percent of those prescribed EFV developed severe liver toxicity. However, only 32 percent of NVP- and 50 percent of EFV-associated episodes of toxicity were detected during the first 12 weeks of therapy.
Toxicity risk was two-fold higher among people with chronic viral hepatitis (69 percent of cases) and much greater among those who were also taking protease inhibitors (82 percent of cases). The highest incidence of severe liver toxicity occurred among patients with hepatitis C who were receiving EFV or NVP in combination with a protease inhibitor. The seven patients who experienced severe NVP-associated liver toxicity did not develop the problem during subsequent EFV therapy, suggesting that the toxicity was drug, rather than class, specific.
See "Hepatotoxicity associated with nevirapine or efavirenz-containing antiretroviral therapy: Role of hepatitis C and B infections," by Mark S. Sulkowski, M.D., David L. Thomas, Shruti H. Mehta, and others, in the January 2002 Hepatology 35, pp. 182-189.
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