Safety and efficacy of once-daily didanosine, tenofovir and nevirapine as a simplification antiretroviral approach

ObjectiveTo assess the efficacy and safety of a once-daily antiretroviral regimen in HAART-experienced subjects with long-lasting viral suppression.MethodsOne-hundred-and-sixty-nine patients with chronically suppressed viral load (limit of detection ResultsAt week 48, the proportion of patients with viral suppression in the QD and in the BID Group, respectively, was 97 vs 100% in the per-protocol analysis ( P=0.497), and 76 vs 86% for the intention-to-treat analysis ( P=0.176). Nevertheless, CD4 count decreased in the QD Group, with a mean decline of 95 cells/mm3(95% CI: 45–145). Twelve subjects in the QD Group (14%) discontinued treatment due to adverse events, mainly nevirapine-related hepatitis (6%). No significant differences regarding the rate of acute pancreatitis or peripheral neuropathy were observed between both groups. A significant improvement in the lipid profile was only seen in the QD Group. High levels of adherence were observed in both groups during follow-up, as well as a good quality of life. At week 48, a reduction in effort to take medication ( P≤0.001) and an increment in the satisfaction with the treatment ( PConclusionTreatment simplification to a once-daily antiretroviral regimen based on didanosine, tenofovir and nevirapine may be a valid approach in HIV-infected subjects with long-lasting viral suppression. Combination of standard doses of didanosine and tenofovir may have contributed to the CD4 cell decline observed with this QD regimen.