Bictegravir 30mg / Emtricitabine 120mg / Tenofovir alafenamide 15mg tablets

Integrase strand inhibitor (INSTI)-based antiretroviral regimens are the preferred choices for treating people with human immunodeficiency virus (PWH). The once-daily single-tablet combination of INSTI bictegravir, co-formulated with emtricitabine and tenofovir alafenamide (BIC/FTC/TAF), has shown effectiveness and good tolerability in randomized clinical trials, both in treatment-naïve (TN) and virologically suppressed patients switched to this regimen. Real-world evidence represents clinical practice and may fill data gaps left by pivotal studies. Based on literature search for real-world studies in Spain within five years, and using clinical trial data as a contextual framework, this narrative review synthesizes observational experience with BIC/FTC/TAF, focusing on the interplay between comorbidities, advanced age, and treatment outcomes from underrepresented subgroups in clinical trials. This fixed-dose combination proved effective and well-tolerated for TN and treatment-experienced PWH, with low virological failure even in difficult-to-treat patients. Low rates of treatment discontinuations due to adverse events or drug-drug interactions aligned with clinical trial findings. Los regímenes antirretrovirales basados en inhibidores de la integrasa (INSTI) son la primera opción para tratar a las personas con virus de la inmunodeficiencia humana (VIH). La combinación en un solo comprimido diario del INSTI bictegravir, coformulado con emtricitabina y tenofovir alafenamida (BIC/FTC/TAF), ha demostrado su eficacia y buena tolerabilidad en ensayos clínicos aleatorizados, tanto en pacientes sin tratamiento previo como en pacientes con supresión virológica que cambiaron a este régimen. La evidencia del mundo real representa la práctica clínica y puede rellenar las lagunas de datos que dejan los ensayos clínicos. Basándose en una búsqueda bibliográfica de estudios del mundo real realizados en España en los últimos cinco años, y utilizando como referencia contextual los datos de los ensayos clínicos, esta revisión narrativa sintetiza la experiencia observacional con BIC/FTC/TAF, centrándose en la interacción entre las comorbilidades, la edad avanzada y los resultados del tratamiento en subgrupos infrarrepresentados en los ensayos clínicos. Esta combinación de dosis fijas demostró ser eficaz y bien tolerada en personas con VIH sin tratamiento previo y con experiencia en el tratamiento, con una tasa baja de fracaso virológico incluso en pacientes difíciles de tratar. Las proporciones de interrupción del tratamiento debido a acontecimientos adversos o interacciones entre medicamentos fueron bajas y acordes con los resultados de los ensayos clínicos.

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Abstract Background Despite advancements in antiretroviral therapy (ART) for people with HIV, barriers to adherence remain, potentially leading to long-term gaps in adherence known as treatment interruptions. These treatment interruptions are associated with viral rebound and can impact the effectiveness of the subsequent regimen and the long-term health of the individual. We aimed to characterize unplanned ART treatment interruptions in the OPERA ® cohort and investigate virologic outcomes among individuals who resumed treatment with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). Methods We identified adults with HIV-1 who were active in care and on an oral ART regimen with ≥ 2 antiretrovirals, including ≥ 1 anchor agent, between 30JUN2021 and 31AUG2023. Individuals with ≥ 1 period of ≥ 45 days without any ART, based on supply from last prescription, were considered to have experienced a treatment interruption. Individuals who resumed treatment by 31AUG2023 were defined as having experienced a treatment interruption with resumption. Each interruption observed during the study period was described, allowing for multiple interruptions per person. Treatment interruptions, pre-interruption regimens, and post-interruption regimens were described. Among individuals who resumed treatment with B/F/TAF, virologic outcomes were investigated through 29FEB2024 using Kaplan-Meier methods. All analyses were repeated with treatment interruption definitions of ≥ 60 and ≥ 90 days. Results Of 76,883 people for whom a treatment interruption could be observed, 8,550 (11%) experienced ≥ 1 period of ≥ 45 days without any ART. By 31AUG2023, 4,163 (49%) individuals resumed treatment (mean: 1.25 per person) and were included in the study population. The median age was 44 years, 81% were male, 52% Black, 41% White, and 18% Hispanic. Median time since HIV diagnosis was 118 months. B/F/TAF was the most common pre- and post-interruption regimen (49% and 51%, respectively). The cumulative probability of achieving virologic suppression on B/F/TAF was 68% (95% CI: 57, 78) when the viral load measurement was ≥ 200 copies/mL at resumption. Conclusions Treatment interruptions occurred in 11% of ART users in routine clinical care during the 26-month study period. Despite treatment interruption increasing the risk for viral rebound, most individuals who resumed treatment with B/F/TAF were able to achieve virologic suppression or avoid virologic failure.

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Abstract Objectives To compare the virologic effectiveness and discontinuation of the commonly prescribed fixed‐dose combination 3‐drug and 2‐drug regimens, bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and dolutegravir/lamivudine (DTG/3TC), in virologically suppressed individuals in routine clinical care in the US. Methods From the OPERA cohort, ART‐experienced, virologically suppressed (viral load <200 copies/mL) adults with HIV who switched to B/F/TAF or DTG/3TC (01AUG2020‐30JUN2022) were followed through 31DEC2022, death, loss to follow‐up or discontinuation. Cox proportional hazard models with stabilized inverse probability of treatment weights were used to assess the association between regimen and time to confirmed virologic failure (cVF 200 ; 2 viral loads ≥200 copies/mL or 1 viral load ≥200 copies/mL + discontinuation) or time to discontinuation. Results A total of 3512 B/F/TAF users were followed for a median of 16 months (IQR: 11, 22); 2327 DTG/3TC users were followed for a median of 15 months (IQR: 10, 21). cVF 200 was observed among 2% of B/F/TAF and 3% of DTG/FTC users, for an adjusted hazard ratio of 0.84 (95% CI: 0.59, 1.18) for B/F/TAF compared with DTG/3TC. Regimen discontinuation was observed among 17% of B/F/TAF and 19% of DTG/3TC users, for an adjusted hazard ratio of 0.83 (95% CI: 0.73, 0.94) for B/F/TAF compared with DTG/3TC. Treatment‐related reasons for discontinuation represented 6% of B/F/TAF and 9% of DTG/3TC discontinuations. Conclusions In this large US cohort, both B/F/TAF and DTG/3TC were well tolerated and effective treatment options among virologically suppressed individuals in routine clinical care, although DTG/3TC tended to be discontinued faster than B/F/TAF.

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BACKGROUND: Polymedication and comorbidities are frequent in aging people with HIV (PWH) and often associated with elevated incidences of adverse events (AEs) and drug-drug interactions (DDIs). The objective of this study was to evaluate the efficacy, safety and practicality of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), an antiretroviral (ARV) therapy with limited DDIs, in an elderly virologically-controlled PWH population. MATERIALS AND METHODS: This study was prospective, multicentric, single-arm conducted in HIV-1 controlled PWH aged over 65 years who switched from a ritonavir- or cobicistat-boosted containing regimen to B/F/TAF. The primary outcome was the proportion of participants maintaining plasma HIV-1 RNA < 50 copies/mL at Week24. Secondary endpoints included biological endpoints and co-morbidity (Charlson) and frailty (Fried) scores. Median (IQR) results are presented. RESULTS: 24 participants aged 69 years (67-73), 79.2 % Caucasian, were analyzed in the intention-to-treat analysis. 75 % of participants were receiving an elvitegravir/cobicistat based regimen. At week24 and week48, 91.7 % of participants maintained a plasma HIV-1 RNA < 50 copies/mL. Study treatment was discontinued in one participant due to virologic failure at week12, possibly related to adherence issues following AE. Drug-related AEs were reported in 6 participants, with one discontinuation at week4 (nightmare/mood disorder). No life-threatening AEs or deaths were reported. No significant modifications from baseline were reported in weight, co-morbidities, kidney parameters, cardiovascular risk or frailty scores at W48. A mild decrease of total cholesterol and triglycerides was reported. CONCLUSIONS: The findings indicate that B/F/TAF is both safe and effective for elderly PWH patients with a prolonged and documented history of HIV infection, multiple co-morbidities and concomitant medication.

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