Nevirapine plus efavirenz plus didanosine: a simple, safe, and effective once-daily regimen for patients with HIV infection.

Conventional highly active antiretroviral therapy (HAART) regimens used to treat human immunodeficiency virus (HIV) infection typically use nucleoside reverse transcriptase inhibitors (NRTIs) and either a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI). Because PI-based regimens are associated with significant long-term toxicity and adherence difficulty, there is a need for novel regimens that maximize combination treatment options. This 12-month, observational, cohort study evaluated the efficacy, safety, and tolerability of a novel three-drug HAART regimen. Drug treatment consisted of nevirapine (NVP), efavirenz (EFV), and didanosine (ddl). Twenty-six treatment-naive and -experienced HIV-1+ men and women were included in the study. Assessment consisted of CD4+ cell count, plasma HIV-1 RNA load, and adverse effects of study medications. After one year of therapy, 11/12 treatment-naive subjects (92%) and 8/9 treatment-experienced subjects (89%) had viral loads < 400 copies/mL. Both groups also had an excellent immune response. At one year, there was a mean increase of 438 CD4+ cells/mm3 among treatment-naive subjects and 367 cells/mm3 among treatment-experienced subjects. Treatment-limiting adverse effects occurred in 3/15 treatment-naive (20%) and 2/11 treatment-experienced (18%) subjects. These preliminary data suggest that the combination of NVP, EFV, and ddl is simple, safe, and effective.