Latest news for Doctors, Nurses and Pharmacists| Latest news for Doctors, Nurses and Pharmacists
For pregnant women
HIV who are receiving dolutegravir (DTG)-based therapies, the two-drug regimen works just as well as three-drug regimens at keeping the viral load to “undetectable” levels without exerting serious adverse effects on neonatal outcomes, according to a study presented at HIV Glasgow 2022 Congress.
The retrospective analysis covered 11 pregnant women who were on DTG plus lamivudine (3TC), and 13 who were on DTG plus two nucleoside retro transcriptase inhibitors (DTG+2NRTIs) during their pregnancy. These women were either naïve to treatment or already on combination antiretroviral therapy (ART) before pregnancy.
Three women in the three drug group had a detectable virus load at delivery, compared to one in the two-drug. One woman on DTG/3TC had a viral blip in the third trimester, possibly due to taking vitamin and iron supplements along with ART. However, the viral load returned to normal at delivery. [HIV Glasgow 2022, abstract P005]
The median CD4 count in the first trimester was 570 cells/mcL and 588 cells/mcL by delivery in the three drug group, compared to 554 cells/mcL and 555 cell/mcL at birth in the second trimester.
Birth outcomes among women who delivered <37 weeks were similar, regardless of the regimen used. All infants had received antiretroviral treatment and were negative at follow-up. There were no reports about neonatal malformations.
“Numerous data from clinical trials and real-life studies has shown that the two-drug regimen DTG/3TC was noninferior to three-drug regimens. [In pregnant women], guidelines recommend regimens including DTG plus a backbone of two NRTIs,” according to presenting study author Dr Layla Pagnucco of IRCCS Fondazione Policlinico San Matteo in Pavia, Italy. [AIDS 2022;36:39-48;
Clin Infect Dis 2022;doi:10.1093/cid/ciac130; J Acquir Immune Defic Syndr 2020;83:e2-e5;
Lancet HIV 2020;7:e332-e339; https://tinyurl.com/23bl2z5a]
“In this case series report, DTG/3TC regimen may represent a valid therapeutic option during pregnancy in patients in whom, for various reasons, DTG/2NRTI regimen is not indicated. Further data and studies are needed to support the evidence of efficacy and safety of DTG/3TC in pregnancy,” Pagnucco added.
Dolutegravir vs efavirenz
Another study that compared DTG with efavirenz was done and found no significant differences in neonatal deaths, stillbirths, or cases mother-to-child HIV transmission.
The analysis included 1,074 HIV-positive pregnant women who received DTG with EFV in five trials (DolPHIN-1 and DolPHIN-2), ADVANCE, NAMSAL and IMPAACT–2010. The DolPHIN trials took place in South Africa and Uganda. ADVANCE was in South Africa, NAMSAL was in Cameroon, IMPAACT 2010 internationally. DolPHIN-1, DolPHIN-2 and IMPAACT 2010 were conducted with women who were already pregnant at screening.
Pooled data revealed no significant difference in the DTG and EFV arms for the composite of vertical transmissions and neonatal death (45 vs 24 events respectively; odds ratio 1.20; p=0.49). None of the infants who participated in the trials were diagnosed with neural tube defects. [HIV Glasgow 2022, abstract P040]
ADVANCE found that women who had been on DTG/emtricitabine FTC/tenofovir alafenamide TAF for 4 years had a higher chance of developing clinical obesity than those on DTG/FTC/disoproxil furate (TDF), or EFV/FTC/TAF (42% vs 27% and 20%).
According to Dr Andrew Hill, University of Liverpool, Department of Pharmacology and Therapeutics in Liverpool, UK, the present data could have important implications. First-line treatment with DTG results in rapid suppression of HIVRNA, which, in turn, might lower vertical transmission. “This analysis includes outcomes after first-line treatment typically up to 6 months before birth.”
Hill warned that the outcome for women who become pregnant after long-term treatment may be different because DTG is associated with an elevated risk of being obese, especially when combined with TAF/FTC.
