by Jeffrey T. Kirchner, DO, AAHIVS, AAHIVM Chief Medical Officer
January 14, 2020
Huhn GD. Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in a Rapid Initiation Model of Care for HIV-1 Infection: Primary Analysis of the DIAMOND Study. Clinical Infectious Diseases, https://doi.org/10.1093/cid/ciz1213. Published: December 27, 2019
Current HIV Treatment guidelines recommend rapid initiation of ART for newly diagnosed patients. However, data looking at the implementation and results of this recommendation are limited. The DIAMOND study is a phase-3 trial evaluating the efficacy and safety of a single-tablet regimen (STR) containing darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a rapid treatment initiation model of care. Inclusion criteria were adults aged ≥18 years who were ART-naïve and newly diagnosed with HIV-1 infection less than 2 weeks from the screening visit. The study enrolled 109 individuals of whom 87% were men with a median age of 28 years. The subjects were started on the four-drug STR at a median time of five days post-HIV diagnosis and one-third started treatment within 48 hours of their diagnosis. All started ART prior to the availability of laboratory results. Overall, 97 of the participants completed the study and 12 discontinued treatment before 48 weeks. None stopped treatment due to drug resistance mutations but mainly due to lab abnormalities. By observed analysis, 92 (96%) of participants achieved HIV-1 RNA < 50 copies/mL and four were < 200 copies m/L. There were no protocol-defined virologic failures and the incidence of both adverse events (AEs) or adverse drug reactions were low. None of the AEs were drug-related, and only 1 (<1%) participant discontinued due to study drug-related AE. At week 48, 98% of participants self-reported a high level of satisfaction with their treatment.
The most recent update in the DHHS guidelines recommends, “that ART be started immediately or as soon as possible after diagnosis to increase the uptake of ART, decrease time to linkage to care and virologic suppression, and reduce the risk of HIV transmission.” For rapid initiation of treatment, recommended regimens include BIC/TAF/FTC, DTG plus (TAF or TDF) plus (3TC or FTC), or (DRV/r or DRV/c) plus (TAF or TDF) plus (3TC or FTC). Implementing rapid start ART at the clinic level presents some financial and logistical challenges but we now have several studies including DIAMOND and RAPID in the U.S. and CASCADE from sub-Saharan Africa showing the efficacy of this strategy.
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