Switching to Two-Drug HIV Regimen Correct as Effective as Three-Drug Plot
The 2-drug routine dolutegravir/lamivudine (DTG/3TC; Dovato) was as soon as enticing as efficient as the three-drug routine bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF; Biktarvy) for placing forward viral suppression in folk with HIV, in conserving with the Spanish segment IV PASO-DOBLE trial.
At 48 weeks, 2.2% of patients who switched from their earlier antiretroviral remedy (ART) to a DTG/3TC routine had a viral load of HIV-1 RNA ≥50 copies/mL versus 0.7% who switched to BIC/FTC/TAF, for a threat distinction of 1.4% (95% CI -0.5 to three.4), reported Esteban Martinez, MD, PhD, of the College of Barcelona, on the Global AIDS Convention in Munich.
No longer one of many people in the DTG/3TC arm and one participant in the BIC/FTC/TAF arm had confirmed virological failure through week 48, outlined as HIV-1 RNA ≥50 copies/mL adopted by a 2d consecutive HIV-1 RNA review of ≥200 copies/mL. There was as soon as no emergent resistance in both remedy community, nor any major variations in CD4 counts, between the groups over the 48-week follow-up, Martinez acknowledged.
“As HIV requires lifelong remedy, optimizing ART in the environment of viral suppression is wished,” Martinez suggested attendees. “DTG/3TC and BIC/FTC/TAF are most smartly-liked regimens in predominant guidelines, however there are no fully powered trials comparing between them.”
A key secondary endpoint of the gape excited by the consequences of each routine on weight switch. Participants in the BIC/FTC/TAF arm obtained a mean 1.81 kg from baseline, whereas folk who switched to the DTG/3TC arm obtained a mean 0.89 kg, for a mean adjusted distinction of 0.92 kg (95% CI 0.17-1.66) through week 48.
The percentage of people with weight reach higher than 5% at week 48 was as soon as considerably higher at 29.9% for the BIC/FTC/TAF community versus 20% for the DTG/3TC community (adjusted OR 1.81, 95% CI 1.19-2.76, P=0.006).
Though weight reach after initiation of ART has been linked to a diminished threat of mortality in underweight or novel-weight patients with HIV, different study recommend that weight reach in the environment of ART might perhaps perhaps also merely consequence in weight problems and cardiometabolic abnormalities, especially in folk with HIV as they age.
When inspecting body mass index (BMI) by seek the recommendation of with, the researchers chanced on no switch in the percentage of people taking DTG/3TC who had weight problems at week 48 versus at baseline. Nonetheless, in the BIC/FTC/TAF arm, the percentage of people with weight problems elevated over time, from 18% at baseline to 21% at week 48.
Earlier ART regimens with nucleoside reverse transcriptase inhibitor (NRTI) 1 capsules affected the quantity of weight reach with BIC/FTC/TAF, however no longer with DTG/3TC. When switching from a prior routine with abacavir (Ziagen), 30.6% of people in the BIC/FTC/TAF arm had higher than 5% weight reach versus 21.1% of those in the DTG/3TC arm, a distinction of about 45%, Martinez pointed out.
The distinction was as soon as about twofold higher in the BIC/FTC/TAF arm when switching from a routine with tenofovir disoproxil fumarate (TDF): 40.7% versus 19.5% in the DTG/3TC arm.
There had been no particular patterns of weight reach linked to NRTI 2 agents or core capsules, Martinez renowned.
Unfavorable occasions were in general identical between the 2 groups, despite the incontrovertible truth that there was as soon as a constructing in direction of a considerably higher percentage of grade 3-4 unfavorable occasions in the BIC/FTC/TAF arm versus the DTG/3TC community (3.6% vs 1.1%, P=0.049). Nonetheless, these were no longer linked to remedy, in conserving with Martinez.
Most attention-grabbing three people discontinued remedy, one in the DTG/3TC arm due to the frequent discomfort and arthromyalgia and two in the BIC/FTC/TAF arm due to the sleep disturbances.
The originate-label, PASO-DOBLE randomized scientific trial is being performed at 30 sites across Spain. Virologically suppressed folk with HIV were eligible to label up in the gape if their present ART routine contained one or extra capsules per day, boosters, or capsules with cumulative toxicity, corresponding to efavirenz (Sustiva) or TDF, and if they’d no prior virologic failure or resistance, no chronic hepatitis B, and no prior use of DTG or BIC.
A whole of 553 people were randomized 1:1 to change from their prior routine to both DTG/3TC (n=277) or BIC/FTC/TAF (n=276). Mean age was as soon as about 50 years, approximately 25% were non-Caucasian, and 26% were female at birth. Participants had been on their prior ART routine for a mean interval of 63 to 66 months, and on any ART for 11 to 12 years. Roughly 50% had obese or weight problems (BMI >25) at baseline. A extra analysis of recordsdata is planned at 96 weeks of follow-up.
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Katherine Kahn is a personnel author at MedPage This day, preserving the infectious ailments beat. She has been a clinical author for over 15 years.
Disclosures
The gape was as soon as funded by ViiV Healthcare.
Martinez has got grants, served on advisory boards, and/or got speaker prices from Merck Bright & Dohme, ViiV Healthcare, Janssen, and Gilead.
Predominant Source
Global AIDS Convention
Source Reference: Ryan P, et al “Non-inaccurate efficacy and much less weight reach when switching to DTG/3TC than when switching to BIC/FTC/TAF in virologically suppressed folk with HIV (PWH): the PASO-DOBLE (GeSIDA 11720) randomized scientific trial” IAC 2024; Summary OAB3606LB.