Latest news for Doctors, Nurses and Pharmacists| Latest news for Doctors, Nurses and Pharmacists
Adults with
HIV-1 (PLHIV) who switched to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) after initially taking dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) or DTG+F/TAF show a consistently high virologic suppression and have few discontinuations over 5 years of follow-up, according to a study presented at the HIV Glasgow 2022 Congress.
“HIV guidelines offer switch strategies for virologically suppressed PLHIV, but long-term clinical follow-up after the regimen switch is often lacking, said the researchers led by Chloe Orkin, physician and professor of HIV Medicine at Queen Mary University London, UK.
Orkin and her team compared the 96-week results on B/F/TAF to those of DTG/ABC/3TC in an open-label extension. This was done after 144 weeks of blinded DTG treatment in two phase III randomized, doubleblind studies of PLHIV initiating initial-line treatment. Study 1489 (n=254); B/F/TAF (vs DTG/ABC/3TC); and study 1490 (265; B/F/TAF/TAF/TAF/TAF/TAF/TAF/TAF/TAF/TAF/TAF/T/TAF/TAF/TAF/TAF/TAF/TAF/TAF/TAF/TAF/TAG+F/TAF/TAF/TAF/TAF/TAF/TAF/TAF/TAF/TAF/NAF/TAF/TAF/TAF/TAF/TAF/TAF/TAF/TAF/TAF/FAF/TAF/TAF/TAF/TAF/TAF/TAF/TAF/TAF/TAF/F/TAF/TAF/TAF/TAF/TAF/TAF/TAF/TAF/TAF [HIV Glasgow 2022, abstract P088]
The cumulative results of PLHIV patients who had been treated with DTG/ABC/3TC, DTG+F/TAF or DTG+F/TAF were then compared. After 144 weeks, they switched to 96 weeks B/F/TAF in an extended-label extension (totaling 240 weeks). They also assessed efficacy as the proportion with HIV-1 RNA <50 copies/mL at each visit after initiating B/F/TAF (missing=excluded [M=E] analysis) and safety by adverse effects (AEs) and laboratory tests.
315 PLHIV were randomly assigned to DTG/ABC/3TC in the first study. 254 (81%) of them entered the open-label extension. In the second study, 325 participants were randomly assigned DTG+F/TAF. 265 (82%) entered the extension phase.
M=E analysis showed greater efficiency than 96 percent at every visit up to week 240 after the switch to B/F/TAF. Eleven PLHIV had HIV-1 RNA ≥50 copies/mL at time of switch, of whom two were found to have M184V while on blinded DTG/ABC/3TC and resuppressed on B/F/TAF.
“No resistance to any components of B/F/TAF occurred in any group of the final resistance analysis population,” the researchers noted.
Safety-wise, 2 out of 519 participants (0.4 percent) in both studies had an adverse event that led to treatment discontinuation. There were no reports of renal AEs causing treatment discontinuation. One participant experienced a grade 3 drug-related AE, but none experienced a grade 4 AE.
Note that there were only small changes in median fasting cholesterol between the switch to B/F/TAF at week 96 and the open label extension at week 96. PLHIVs who switched to DTG/ABC/3TC experienced greater weight gains than those who switched to DTG+F/TAF.
“These results provide additional long-term evidence of the safety and efficacy of B/F/TAF in those who switch from a DTG-containing regimen,” the researchers said.
Another study presented at the HIV Glasgow 2022 Congress showed safety and efficacy in older PLHIVs with a history of HIV infection, multiple comorbidities and comedication. Twenty-seven participants were enrolled in eight French clinical centres, of whom 91.7 percent maintained a plasma viral load of <50 copies/mL at week 24. [HIV Glasgow 2022, abstract P038]
