Single-tablet combo regimen fares well in HIV treatment
The guideline-recommended, single-tablet, fixed-dose regimen comprising bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) was noninferior to the dolutegravir and F/TAF (D/F/TAF) regimen in persons living with HIV (PLHIV), according to data presented at IAS 2019.
In a phase III trial, 565 virologically suppressed adults (median age 51 years, 86 percent male) who were receiving D/F plus either TAF or tenofovir disoproxil fumarate (TDF) were randomized 1:1 to switch to either once-daily B/F/TAF or D/F/TAF with matching placebo. [IAS 2019, abstract MOAB0105]
Overall, HIV-1 RNA ≤50 c/mL was achieved by a majority of B/F/TAF and D/F/TAF recipients (93 percent and 91 percent, respectively) at week 48.
The incidence of adverse events (AEs) was low at 2 percent for both arms, with the most common being nasopharyngitis, diarrhoea, and upper respiratory tract infection, and a treatment discontinuation rate of only 2 percent.
These findings demonstrated that B/F/TAF was noninferior to D/F/TAF and generated a high rate of virologic suppression, thus underlining the efficacy of the former regimen for PLHIV, noted the researchers.
Another study comprising 470 women (mean age 40 years) demonstrated sustained virologic suppression in 98.5 percent of women who switched from a baseline regimen of elvitegravir and cobicistat (E/C) plus F/TAF, E/C/F/TDF, or atazanavir, ritonavir plus F/TDF to B/F/TAF 50/200/25 mg at week 48, as well as in 99.5 percent of those receiving B/F/TAF throughout the 96-week trial duration. [IAS 2019, abstract MOAB0106]
Over a median exposure of 76.6 weeks, B/F/TAF was well tolerated, with low rates of grade 3/4, treatment-related, or serious AEs (6.7 percent, 5.8 percent, and 5.2 percent, respectively). Only one B/F/TAF recipient during the extension phase discontinued treatment due to drug-related AEs.
As observed in other trials, the high virologic suppression and low AE incidence contribute important long-term data on the safety, tolerability, and efficacy of B/F/TAF in women living with HIV, said the researchers.
A study comprising an elderly cohort (n=86, mean age 70 years, 13 percent female) mirrored the above-noted findings, with 98 percent of B/F/TAF recipients achieving virologic suppression at week 24 after switching from E/C/F/TAF or a TDF-containing regimen. [IAS 2019, abstract MOPEB238]
There were no drug-related AEs nor drug-related serious AEs reported. Treatment cessation rate due to AEs was also low (3.5 percent).
“As the proportion of older people living with HIV is increasing, it is important to study the long-term safety and efficacy of antiretroviral therapy in older individuals,” said the researchers. The safety and efficacy findings support the transition to B/F/TAF in virologically suppressed older PLHIV.