In a Phase 2 study of treatment-naive individuals, rates of virologic suppression were equivalent to those seen with efavirenz (both treatment groups also were given TDF/FTC), with fewer adverse effects, including fewer neuropsychiatric adverse effects.
In recent years, a number of studies have evaluated 2-drug or even 1-drug ARV regimens, either in initial therapy or in switch regimens for patients with virologic suppression on 3-drug therapy. In general, these have not been as successful in achieving or maintaining virologic suppression as standard ARV therapy.
Leading up to this year, some researchers and clinicians had optimistically viewed dolutegravir an invincible ARV, a drug so mighty that it was unlikely to fail, and even more unlikely to be victim to emergent resistance mutations. Two presentations at CROI demonstrated the vulnerability of dolutegravir to failure and to the development of resistance when it is used as monotherapy.
At the ASM Microbe meeting in June, researchers from Gilead Sciences presented data on use of TDF/FTC (Truvada) PrEP in the United States according to sex and race. They evaluated national pharmacy databases to identify prescriptions of TDF/FTC given for PrEP between January 2012 and September 2015; they eliminated prescriptions given for ART, PEP, and HBV.
This publication presents the results of San Francisco General Hospital's Ward 86 pilot study of immediate ART initiation. This RAPID program systematically offered ART to patients upon diagnosis of HIV; patients were referred from HIV testing sites in San Francisco. Of the 39 patients who participated in the pilot, 95% of them started ART within 24 hours.
The PARTNER Study, a multisite European study, evaluated rates of HIV transmissions within serodifferent heterosexual and MSM couples (n = 548 and n = 340, respectively, contributed eligible data). The HIV-positive partners were on ART with HIV RNA levels of <200 copies/mL, and the couples engaged in ongoing condomless sex (vaginal and/or anal) during a median of 1.3 years per couple (1,238 "couple years"). It was noted that 33% of HIV-negative MSM had outside partners, compared with 4% of HIV-negative heterosexual subjects).
We know that very early treatment in acute HIV infection decreases HIV RNA; this study shows it also greatly decreases proviral DNA (and reservoir size). Researchers investigated 2 small cohorts of patients in Thailand with acute (and very early) HIV infection, 1 untreated and 1 treated with ART very early; patients were followed for 144 weeks. They found that DNA integration occurs early and rapidly, and that with early and continued ART, total and integrated HIV DNA drops quickly and continues to decrease over time.