Seguridad a corto plazo y la tolerabilidad de ABC / 3TC administrados una vez al día (QD) En comparación con los componentes separados, administrados dos veces al día (BID): Resultados de ESS101822 (ALOHA)

Highly active antiretroviral therapy (HAART) has contributed to decreased mortality and morbidity associated with HIV/AIDS1, 2. Non-adherence to antiretroviral medications is associated with virological failure, clinical disease progression and mortality; therefore good adherence to HAART is a critical determinant of its success3. To maximize the likelihood of success, clinicians have increasingly considered adherence and adverse events (AEs) in their treatment decisions4, 5. Therapy simplification, including reduced pill count, is a regimen-related strategy to improve adherence6. z As a once-daily (QD) fixed dose combination, abacavir/lamivudine (ABC/3TC) has shown favorable efficacy and safety in conjunction with a variety of background therapies. The tolerability of QD dosing is mostly comparable to that of ABC and 3TC administered BID. However, at least one study noted a higher rate of hypersensitivity to abacavir (ABC HSR), including severe ABC HSR in subjects on the QD versus BID regimen7. The evaluation of safety endpoints, especially ABC HSR in a “real world” population is of particular interest, as the incidence of suspected HSR varies across studies. z The aim of the Abacavir Lamivudine Once-daily HIV Assessment (ALOHA) Study was to evaluate the short-term (12-week) safety of ABC/3TC (EPZICOM™) in antiretroviral-naïve subjects, when administered as a part of an investigator-selected HAART regimen. The study duration was based on the short window of time after initiation of ABC and 3TC during which safety endpoints associated with these drugs are known to occur. In addition to safety and tolerability, adherence, patient satisfaction and efficacy endpoints were also evaluated.