Stavudine, didanosine and nevirapine in antiretroviral-naive HIV-1-infected patients

In an ongoing, open-label, non-comparative study, the safety a nd efficacy of nevirapine/stavudine/didanosine were evaluated in 100 antiretroviral-nai ve adults with CD4 cell counts greater than or equal to 200 cells/mm(3) and plasma HIV-1 RNA (pVL) greater than or equal to 5000 copies/ml. Sixty pati ents received nevirapine twice daily (VIRGO I) and 40 received nevirapine o nce daily (VIRGO II); all patients received didanosine once a day. After me dian follow-ups of 44 weeks in VIRGO I and 30 weeks in VIRGO II, the follow ing virological results were observed (ongoing study): an intent-to-treat, non-completer equals failure analysis at week 24 showed the proportions of patients with pVL <500 copies/ml were 78% in VIRGO I (60% <50 copies/ml) an d 75% in VIRGO II. An on-treatment analysis at week 52 showed 80% of patien ts with a pVL <500 copies/ml and 59% with <50 copies/ml in VIRGO I. The mea n CD4 cell count increase was +171 cells/mm(3) at week 24 and +218 cells/mm (3) at week 52 in VIRGO I and +158 cells/mm(3) at week 24 in VIRGO II. Cuta neous rash (grades 1 to 3) occurred in 24% of patients leading to nevirapin e discontinuation in eight of 24 patients. Five other patients discontinued therapy during the first 24 weeks because of hepatic cytolysis, peripheral neuropathy or biological pancreatitis. The nevirapine/stavudine/didanosine combination is a convenient and safe regimen, with rapid and potent immuno logical and antiviral effects sustained over 12 months.