Furthermore, there was no resistance to treatment for any of the components of Biktarvy® among participants in two phase III clinical trials and their subsequent open-label extension phase.
A study presented at the Conference on Retroviruses and Opportunistic Infections (CROI), held recently virtually due to the COVID-19 pandemic, has concluded that, after four years of treatment, Biktarvy® (combination of bictegravir, tenofovir alafenamide [TAF ] and emtricitabine; BIC / FTC / TAF) would show high levels of efficacy and safety both in people without treatment experience and in those who switched to Biktarvy® from dolutegravir-based treatments (Tivicay®, also in Juluca®, Dovato® and Triumeq ®).
The present study comes from the joint analysis of two phase III clinical trials and their subsequent open extension phase (OLE), which for the present analysis allowed up to a maximum of 4 years of follow-up, although the study will continue and results may be published up to 5 years of follow-up.
The first of the studies - study 1489 - compared BIC / FTC / TAF with Triumeq® (dolutegravir / abacavir / lamivudine; DOL / ABC / 3TC) and the second - known as study 1490 - BIC / FTC / TAF with dolutegravir / lamivudine / TAF. In both cases the participants had no treatment experience. These studies ended their double-blind phase at 144 weeks, after which all participants were offered to continue in the study with BIC / FTC / TAF. In this way, as much data could be obtained from people with no treatment experience as from those with experience with dolutegravir-based treatments.
In Study 1489 a total of 314 participants took BIC / FTC / TAF and 315 received DOL / ABC / 3TC during the double-blind phase. At the end of the double-blind phase of the study, 215 of those initially assigned to BIC / FTC / TAF and 254 of those initially assigned to DOL / ABC / 3TC took BIC / FTC / TAF within the open phase of the study.
In Study 1490 a total of 320 participants took BIC / FTC / TAF and 325 received dolutegravir-based therapy during the double-blind phase. At the end of the double-blind phase of the study, 254 of those initially assigned to and 265 of those initially assigned to dolutegravir-based treatment took BIC / FTC / TAF within the open-label phase of the study.
The efficacy of BIC / FTC / TAF in maintaining undetectable viral load was greater than 98% during the four years of follow-up in both studies. Furthermore, there was no resistance to treatment for any of the BIC / FTC / TAF components among participants in studies 1489, 1490 and their subsequent open-label extension phase.
Pooling the data from both studies, only one BIC / FTC / TAF participant experienced a side effect leading to treatment discontinuation. In fact, grade 3 or 4 side effects (the most serious) were very rare with BIC / FTC / TAF.
Treatment interruptions due to renal-type adverse effects were not recorded. Among participants who took 192 weeks of BIC / FTC / TAF, the median weight gain was between 4.6 and 5.0Kg depending on the study.
The reductions in bone mineral density (BMD) after 192 weeks with BIC / FTC / TAF were 1.5% in the hip and 0.9% in the spine. 13% of the participants with hip osteopenia and 3% of those with spinal osteopenia at the start of the study improved their BMD to normal levels after 192 weeks of treatment with BIC / FTC / TAF. On the other hand, 4% of people with normal BMD at baseline in the hip and 6% of those with baseline normal BMD in the spine progressed to osteopenia during the 192 weeks of treatment with BIC / FTC / TAF. No participant developed osteoporosis.
Taken together, the data from the two trials and their respective open-label extension phases show that initiating antiretroviral therapy with BIC / FTC / TAF is a safe and effective option that allows achieving and maintaining long-term virological suppression in a wide variety of ways. of patients with HIV.
Link: NATAP / Elaboración propia (gTt).
References: Workowski K, et al. 4-year outcomes of B/F/TAF in treatment-naive adults. Conference on Retroviruses and Opportunistic Infections Virtual Boston USA March 6-10, 2021