Pilot Study of a Novel Short-Cycle Antiretroviral Treatment Interruption Strategy: 48-Week Results of the Five-Days-On, Two-Days-Off (FOTO) Study

AbstractPurpose: The challenges associated with daily lifelong antiretroviral therapy (ART) have stimulated interest in alternative treatment schedules, including planned, cyclical interruptions of therapy in patients with virologic suppression and sufficient CD4+ T-cell counts. Method: We conducted a 48-week, open-label, single-arm, prospective pilot study of a novel short-cycle treatment interruption strategy. Upon enrollment, 30 HIV+ individuals with a history of durable viral suppression on daily ART changed their weekly treatment schedule to 5 consecutive days on treatment (typically Monday through Friday) followed by 2 days off treatment (five-on, two-off, or FOTO treatment schedule). Results: At 24 and 48 weeks, as-treated analysis revealed that virologic suppression was maintained in 26/29 subjects (89.6%), including 100% of subjects taking efavirenz-based regimens. Participants adhered well to the FOTO treatment schedule and expressed a strong preference for the FOTO treatment schedule compared t...