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Safety of Switching Nevirapine Twice Daily to Nevirapine Once Daily in Virologically Suppressed Patients

2009; Lippincott Williams & Wilkins; Volume: 50; Issue: 4 Linguagem: Inglês

10.1097/qai.0b013e318198a0cc

1944-7884

Daniel Podzamczer, Montserrat Olmo, José Sanz, Vicente Boix, Eugènia Negredo, Hernando Knobel, Peré Domingo, Juan A. Pineda, Consuelo Viladés, José Hernández Quero, Lluís Force, Juan González Lahoz, Pepa Muñoz, Josep M. Llibre, Ana Mariño, Enrique Ortega, David Dalmau, Josep M. Gatell, Esperanza Antón, Julio Sola, Marı́a José Galindo, Enric Pedrol, Jesús Sanz, Javier de la Torre, Juan Flores,

HIV/AIDS Research and Interventions

Background: The strategy of switching nevirapine (NVP) twice daily to once daily was evaluated. Methods: Forty-eight-week randomized, open, multicenter trial. Stable HIV-infected patients on NVP twice daily for >12-18 weeks with alanine aminotransferase (ALT) <2.5, the upper normal limit were randomized to continue their regimen or switch to NVP 400 mg once daily. Primary end point was the proportion of ALT/aspartate transaminase (AST) ≥grade 3. Results: Two hundred eighty-nine patients were included, mean CD4 620 cells per microliter. Noninferiority was demonstrated in the per protocol analysis, with 97.9% (once daily) and 99.3% (twice daily) of patients event free (difference, 1.4%; 95% confidence interval, −1.95% to 5.4%), whereas 81.8% vs. 93.8% were event free by intent-to-treat switch = toxicity analysis (difference, 12%; 95% confidence interval, 4.6% to 19.4%). Only 4 patients (3 once daily, 1 twice daily) had NVP-related grade 3/4 ALT/AST increases, but in 2 of them (once daily), transaminases decreased despite continuation with NVP. Two other once daily patients presented grade 3/4 ALT/AST increase due to well-documented acute hepatitis A virus or hepatitis C virus infection. Grade 2 ALT/AST increases occurred in 11.2% (once daily) vs. 10.3% (twice daily) of patients (P = 0.80). A larger number of once daily patients were lost to follow-up/violated protocol (15% vs. 5%). Conclusions: In patients on standard twice daily NVP-containing regimens for at least 12-18 weeks, per protocol analysis showed that switching to once daily NVP was not inferior to continued twice daily NVP in terms of the predefined noninferiority margin of 10% for hepatotoxicity.