Patients switching to B/F/TAF sustain long-term viral suppression
Switching to bictegravir/emtricitabine/tenofovir was safe and effective, resulting in sustained viral suppression among people living with HIV, according research presented at the HIV Glasgow virtual meeting.
Study findings presented at the meeting also showed that bictegravir/emtricitabine/tenofovir (B/F/TAF) was associated with a high level of effectiveness and safety in a real-world clinical cohort.
The real-world BICSTaR study aimed to assess the effectiveness, safety and tolerability of B/F/TAF in routine clinical practice among more than 1,400 ART-naive (TN) and ART-experienced (TE) people living with HIV (PLWH) in Europe and Canada. The 12-month analysis of PLWH receiving B/F/TAF assessed HIV1 RNA, drug-related adverse events (AEs), persistence and weight/BMI change among study participants.
By March 2020, 513 participants had completed a 12-month visit. According to the data from these participants, the baseline prevalence of comorbidities was 76%, with the most common being neuropsychiatric problems (28%), hyperlipidemia (18%) and hypertension (18%). At the 12-month mark, 100% of TN and 96% of TE participants had a viral load of less than 50 copies/mL. This high effectiveness was seen in men and women, including older participants.
The study also demonstrated that drug-related AEs occurred in 14% of TN and 15% of TE participants, with the most common being gastrointestinal (5%) and neuropsychiatric (4%), although discontinuations because of drug-related AEs were low 3.6% among TN and 7.2% among TE. Additionally, 90% of study participants remained on B/F/TAF.
Participants experienced an average weight change of gaining 2.5 and 0.9 pounds at 12 months among TN and TE participants, respectively, with small changes in BMI of +0.8 kg/m2 for TN participants and +0.3 kg/m2 among TE, according to the study.
Based on these results, the researchers summarized that the use of B/F/TAF was associated with a high level of effectiveness and safety through 12 months among both male and female and older PLHIV.
The second study assessed possible inferiority of switching to B/F/TAF from an atazanavir (ATV) or darunavir (DRV) protease inhibitor (PI)-based regimen and aimed to established the safety and efficacy of switching to B/F/TAF.
According to the abstract, virologically suppressed PLWH on boosted ATV or DRV plus either F/tenofovir disoproxil fumarate or abacavir/lamivudine for 6 months or longer before screening were randomly assigned to 1:1 to B/F/TAF or to stay on baseline PI regimen (SBR). After week 48, all participants received B/F/TAF in an open-label extension (OLE) study. Researchers then assessed efficacy and safety.
In total, 577 participants were randomly assigned and treated 290 with B/F/TAF and 287 with SBR. After 48 weeks, 272 of participants were randomly assigned to B/F/TAF and 244 were randomly assigned to SBR, entered the OLE and received B/F/TAF.
According to the study, among the OLE group, HIV-1 RNA of less than 50 copies/mL was maintained in 97% to 100% of participants at all time points through 156 weeks and no participants developed resistance to B/F/TAF or discontinued because lack of efficacy.
The study demonstrated that drug-related AEs occurred in 14.2% on B/F/TAF, with the most common being headache (2%). Of these participants, six had an AE leading to premature study drug discontinuation, four of which were during the OLE.
The authors concluded, “Long-term follow-up of PLWH switching to B/F/TAF from a boosted PI regimen demonstrates continued high rates of virologic suppression with no emergent resistance and was safe and well tolerated through a maximum of 156 weeks.”
- Rockstroh J, et al. Abstract P036. Presented at: HIV Glasgow 2020; Oct. 5-8, 2020 (virtual meeting).
- Spinner C, et al. Abstract P046. Presented at: HIV Glasgow 2020; Oct. 5-8, 2020 (virtual meeting).