Once-A-Day Therapy for HIV Infection: A Controlled,Randomized Study in Antiretroviral-Naive HIV-1-Infected Patients

Abstract

Background

Complex antiretroviral regimens require optimal adherence to maintain long-lasting effectiveness. Simpler regimens, possibly with easy schedule and low pill burden, are needed for the long-term treatment of HIV infection.

Objective

To assess the efficacy and tolerability of a once-a-day highly active antiretroviral therapy (HAART) compared with two other conventional twice-a-day regimens.

Methods

In a prospective and randomized study, anti-retroviral-naive patients received either EFV+ddI+3TC (once-a-day regimen; OD), or EFV+Combivir® (twice-a-day and low-pill burden regimen; BID-low) or NFV+Combivir (twice-a-day and high-pill burden regimen; BID-high). Primary outcome was the proportion of patients with viral load <50 copies/ml at week 52 of follow-up. Results were evaluated according to intention-to-treat and on-treatment analysis.

Results

Thirty-four patients in each arm were enrolled. Baseline characteristics were similar in the three groups. The proportion of patients with viral load <50 copies/ml at week 52 were 74.4, 74.4 and 50.0% for OD group, BID-low group and BID-high group, respectively (P=0.02, ITT analysis). According to on-treatment analysis, the same figures were 88.9, 85.7 and 60% (P<0.02). Overall, 26 (25.5%) patients discontinued treatment for different reasons and immune recovery was similar in all study arms.

Conclusions

Once-a-day HAART with ddI+3TC+EFV is a safe and effective alternative to twice-a-day regimens. Once-a-day therapy, with its simple daily schedule, may be proposed as one of the first choice treatments in HIV infection.