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Testing the Boundaries of 2-Drug ART: Early Data on Efficacy and Safety for Rapid ART

Eric S. Daar, MD

Chief, Division of HIV Medicine
Harbor-UCLA Medical Center
Professor of Medicine
David Geffen School of Medicine at UCLA
Los Angeles, California

Eric S. Daar, MD, has disclosed that he has received consulting fees from Genentech, Gilead Sciences, and ViiV and funds for research support from Gilead Sciences, Merck, and ViiV.

View ClinicalThoughts from this Author

Released: December 4, 2020

During the past few years, there has been an increasing interest in initiating ART at the time of first HIV care visit—the so-called rapid start or same day start strategy. Randomized, controlled studies in resource-limited settings have shown that rapid start results in shorter time to virologic suppression, enhanced engagement in care, and higher rates of virologic suppression. In resource-rich communities, observational studies show that rapid start ART is feasible and results in good virologic suppression. Although there are no definitive data from randomized controlled trials in more resourced settings showing that rapid start results in improved linkage and retention to care, there is considerable experience demonstrating that the risks of this strategy are very low.

When one considers rapid start ART for a particular person with HIV, it is very important to remember that treatment will be initiated before baseline information is obtained that normally guides therapeutic choices. This information includes hepatitis B virus (HBV) infection status, renal and hepatic function, HLA-B*5701 status, genotypic drug resistance test results, and HIV-1 RNA level. To mitigate the risk of choosing a therapeutic regimen without this information, appropriate laboratory studies are sent so prompt adjustment of the ART regimen can be made, if the information received from the studies indicates that such an adjustment is needed. The risk of transmitted drug resistance may be addressed by choosing regimens that include drugs with high barriers to resistance and for which transmitted resistance is relatively rare, such as pharmacologically boosted darunavir or high barrier INSTIs, for example, dolutegravir (DTG) or bictegravir, coupled with 2 NRTIs, the most typical of which are tenofovir alafenamide and lamivudine (3TC) or emtricitabine in today’s modern regimens.

To further simplify therapy in those considering rapid start ART, there has been interest in using the recently approved 2-drug regimen of DTG/3TC. This regimen has been shown to be effective in both initial ART regimens and in simplifying ART in persons with virologic suppression on a 3- or 4-drug ART regimen. Although this 2-drug regimen includes an agent with a high barrier to resistance (DTG), it is not the most effective regimen if there is transmitted 3TC resistance—however unlikely—and it is not sufficiently active against HBV in patients with chronic HBV coinfection. In addition, there are limited data with this regimen in those with baseline HIV-1 RNA > 500,000 copies/mL (viral load level would not be known when considering the rapid start strategy). At the 2020 HIV Glasgow Virtual conference, Rolle and colleagues presented data from the single-arm, open-label STAT study evaluating the safety and efficacy of this regimen in patients starting therapy before laboratory results are available. Persons included in the study were 18 years of age or older, were diagnosed with HIV infection within 14 days of study entry, and did not yet have available results from baseline laboratory testing. The study included 131 participants, and the key efficacy endpoint was plasma HIV-1 RNA < 50 copies/mL at 24 weeks. Modification of ART was allowed by protocol for any reason, including decisions made in response to laboratory results that became available after ART was initiated. Among enrolled participants, 7 had chronic HBV infection, 1 had transmitted 3TC resistance (M184V), and 19 had baseline HIV-1 RNA > 500,000 copies/mL (10 with baseline HIV-1 RNA ≥ 1 million copies/mL). In the overall population, the rate of virologic suppression at 24 weeks was 78% (102/131) by intention-to-treat analysis where missing results equal failure of the regimen. In the observed analysis of those with data available at 24 weeks, 92% (102/111) had HIV-1 RNA < 50 copies/mL, including 8 of 10 with baseline HIV-1 RNA > 1 million copies/mL; 87% achieved virologic suppression by Week 24 without modification of the DTG/3TC regimen. Overall, DTG/3TC was noted to be well tolerated and no treatment-related resistance to HIV or HBV emerged over the 24 weeks. The authors concluded that it was feasible to use DTG/3TC as a first-line regimen in a rapid ART setting. 

It is worth noting that for now, the data remain limited to a relatively small number of individuals, there was no control group, and at the time of presentation, only 24 weeks of follow-up data were available. In addition, the potential benefits of this strategy over using a standard 3-drug regimen initially and then switching after baseline laboratory data are available and the patient has demonstrated a good virologic response should be considered.

Do you think these results are intriguing? Would you consider rapid ART with this 2-drug regimen? Please share your thoughts in the comments section.

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Educational grant provided by:
Gilead Sciences
ViiV Healthcare
Janssen Therapeutics, Division of Janssen Products, LP

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