Efficacy and tolerance of nevirapine in clinical practice

• Published in: AIDS (London) Vol. 14; p. S64
• Main Authors: Tellez, MJ, Diaz, B, Fernandez, C, Estrada, V, Roca, V, Fernandez-Cruz, A
• Format: Journal Article
• Language: English
• Published: 01-10-2000
• Subjects: alanine transaminase; aspartate aminotransferase; CD4 antigen; g-Glutamyltranspeptidase; Human immunodeficiency virus 1; nevirapine
• ISSN: 0269-9370

Clinical trials have shown the efficacy of nevirapine as well as a good tolerance, but little information is available about its use in clinical practice. The aim of our study is to evaluate the efficacy and toxicity of nevirapine in clinical practice. Prospective study of 111 patients undergoing 12 months antiretroviral treatment including nevirapine. 66.6% of the patients were male, with an age of 38.3 plus or minus 8.2 years (mean plus or minus SD). 39.6% of them were UDVP, 32.4% homosexual, 18.9% heterosexual, the infection path being unknown in 9%. Seventy-six patients (68.4%) have received previous treatment (group I), 22.3% with two INTI and the remainder with a combination including at least one IP, and 35 (31.5%) were naive (group II). Fifty-one patients (45.9%) were coinfected by hepatitis C virus. The CD4 lymphocyte count was 421 plus or minus 269 and the log of viral load was 3.93 plus or minus 0.9 in group I, versus 463.6 plus or minus 227 and 4.3 plus or minus 0.8 in group II. The following of the treatment was 97.3, 85.5, 72.9 and 57.6% after 3, 6, 9 and 12 months, respectively. At the beginning of therapy, nevirapine was associated with two INTI in 65.4% of the patients, and with two INTI plus one IP in 32.7%. Significant decrease in the viral load (VL) were observed only after 3 months for group I, while in group II the decrease was sustained for all the study (after 12 months 77.27 of the patients showed undetectable VL). Although the CD4 lymphocyte increase was significant in all the patients, but for group only was significant in group II. An increase of cholesterol was detected after 12 months only in group I (P < 0.04). No changes were observed in triglycerides, alanine aminotransferase or aspartate aminotransferase. gamma -glutamiltranspeptidase (GGT) increased during the study from 81.17 plus or minus 132.4 at the beginning to 204.97 plus or minus 255.5 after 12 months. In hepatitis C virus coinfected patients the rising of GGT was significantly higher than in non-coinfected ones (P < 0.01). Nevirapine therapy was interrupted in 35 patients: 30 in group I, 18 due to virological failure, 5 due to rash and 5 due to hepatotoxicity, with a state III-IV of GGT (4 of them had hepatitis C virus infection); 5 in group II, 1 due to virological failure and 4 due to rash. Nevirapine is an effective antiretroviral therapy, mainly for naive patients, achieving good levels of VL and CD4. It is well tolerated, and the rate of adverse effects is low. GGT may be a marker of hepatic toxicity, very important for hepatitis C virus coinfected patients and in who have received previous treatment.