Bisher AKIL, MD

One tablet or more?

In HIV on May 14, 2009 at 7:15 pm

Many patients have heard about the one-a-day treatment for HIV, and wondered if they could switch to  it. To answer that, here is a 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. Published in Journal Watch. Original article: 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 patientsJ Acquir Immune Defic Syndr 2009 Apr 7;

Comments: Although we have over 23 different medications to treat HIV, the number of combination are in fact much less than that. A change of a regimen is usually advised when the regimen fails, or the patient is not compliant with the treatment and there is a concern about that regimen failing. In this study, neither situation exists. This is mainly a post marketing study sponsored by a company who wishes many more people would take their drug over their existing and functioning regimen. BA

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