1. Home>
2. Specialties>
3. HIV/AIDS Clinical Care>
4. Summary and Comment

Simplification of ART

In a U.S. clinical trial, patients who had never failed ART and switched to once-daily efavirenz/tenofovir/FTC maintained virologic suppression at the same rate as those who continued their baseline regimens.

Combination antiretroviral therapy (ART) has dramatically reduced HIV-related morbidity and mortality, but pill burden and adverse effects continue to frustrate even the most adherent, successfully treated patients. Is simplification of ART to a once-daily, single-pill regimen a reasonable option for patients who are virologically suppressed on more-complicated regimens?

In this 48-week, multicenter, open-label trial, 306 patients who had viral loads <200 copies/mL on stable PI- or NNRTI-based ART were randomized to either stay on their baseline regimen or simplify to once-daily efavirenz/tenofovir/FTC (Atripla). Per study protocol, all patients were either receiving their first ART regimen or had documented virologic suppression on a PI-based regimen before switching to their baseline regimen. Study participants were primarily young, healthy men who had demonstrated 96% adherence to ART (median duration, 3 years; 53% PI based). Several members of the research team were employees of the makers of efavirenz/tenofovir/FTC.

Treatment simplification was noninferior to treatment continuation, with 89% and 88% of each group, respectively, maintaining viral loads <200 copies/mL at 48 weeks. Similar results were seen with a more stringent threshold for virologic suppression (<50 copies/mL) and in analyses stratified by baseline treatment regimen (PI based vs. NNRTI based). Discontinuation rates were similar between the treatment arms. The most common reasons for discontinuation were adverse effects in the simplification group (5%; primarily nervous system or psychiatric symptoms in patients previously treated with PIs) and withdrawal of consent in the continuation group (7%).

Adherence rates remained high in both groups throughout the study. Not surprisingly, patients randomized to simplification preferred the new regimen and reported improvements in quality of life, as well as in symptoms related to HIV treatment, such as diarrhea, abdominal bloating, body image, and sexual dysfunction.

Comment: These findings suggest that simplification to once-daily efavirenz/tenofovir/FTC is an effective option for patients who have done well on an initial complicated regimen. More heavily pretreated patients with a history of virologic failure are likely to have archived mutations that could make this treatment strategy less effective. Even the most appropriate candidates for simplification should be followed closely for evidence of virologic rebound.

— Sonia Nagy Chimienti, MD

Published in Journal Watch HIV/AIDS Clinical Care May 11, 2009

Citation(s):

DeJesus E et al. Simplification of antiretroviral therapy to a single-tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1–infected patients. J Acquir Immune Defic Syndr 2009 Apr 7; [e-pub ahead of print].

• Medline abstract (Free)

2011 Year in Review