Elvitegravir 150mg / Cobicistat 150mg / Emtricitabine 200mg / Tenofovir alafenamide 10mg tablets

BACKGROUND: HIV-infected, treatment-experienced adults with a history of prior resistance and regimen failure can be virologically suppressed but may require multitablet regimens associated with lower adherence and potential resistance development. METHODS: We enrolled HIV-infected, virologically suppressed adults with 2-class to 3-class drug resistance and at least 2 prior regimen failures into this phase 3, open-label, randomized study. The primary endpoint was the percentage of participants with HIV-1 RNA <50 copies per milliliter at week 24 [Food and Drug Administration (FDA) snapshot algorithm]. RESULTS: For 135 participants [elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) plus darunavir (DRV), n = 89; baseline regimen, n = 46], most of whom were taking a median of 5 tablets/d, simplification to E/C/F/TAF plus DRV was noninferior to continuation of baseline regimens at week 24 (plasma HIV-1 RNA <50 copies per milliliter: 96.6% vs. 91.3%, difference 5.3%, 95.001% CI: -3.4% to 17.4%). E/C/F/TAF plus DRV met prespecified criteria for noninferiority and superiority at week 48 for the same outcome. E/C/F/TAF plus DRV was well tolerated and had an improved renal safety profile compared with baseline regimens, with statistically significant differences between groups in quantitative total proteinuria and markers of proximal tubular proteinuria. Compared with baseline regimens, participants who switched to E/C/F/TAF plus DRV reported higher mean treatment satisfaction scale total scores and fewer days with missed doses. CONCLUSIONS: This study demonstrated that regimen simplification from a 5-tablet regimen to the 2-tablet, once-daily combination of E/C/F/TAF plus DRV has durable maintenance of virologic suppression and improvements in specific markers of renal safety. Such a strategy may lead to greater adherence and improved quality of life.

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Purpose: To review published evidence on alternative administration methods for antiretroviral therapy in patients unable to swallow tablets. Methods: We conducted a scoping review using PubMed, Web of Science, and Google Scholar databases from 2011 to 2025. We included studies reporting pharmacokinetic data, clinical outcomes, or safety data on crushed, dispersed, or enterally administered antiretroviral formulations. Four independent reviewers screened 1,474 articles after duplicate removal, with 12 studies meeting selection criteria. Results: We identified 12 studies (8 case reports, 2 case series, 2 cohort studies) describing alternative administration of antiretrovirals. Key findings included: (1) Bictegravir/emtricitabine/tenofovir alafenamide was associated with viral suppression when dissolved and administered enterally; (2) Dolutegravir/abacavir/lamivudine crushed via nasogastric tube was associated with viral suppression within 10 months; (3) Dolutegravir requires separation from enteral feeds containing polyvalent cations to avoid chelation and reduced absorption. (4) Most nucleoside reverse transcriptase inhibitors (NRTIs) could be crushed or dissolved, while non-nucleoside reverse transcriptase inhibitors (NNRTIs) showed variable stability. (5) Therapeutic drug monitoring was recommended for integrase inhibitors administered enterally. Conclusion: This review provides evidence suggesting the use of modified ART formulations when standard oral administration is not possible. In situations where swallowing difficulties prevent the use of whole tablets, alternative methods such as crushing, or dissolving may offer a practical approach to maintain treatment continuity. Alternative administration ART, namely INSTI-based regimens and NRTIs, may help maintain viral suppression in these settings, provided that drug-specific pharmacokinetic considerations and enteral feeding interactions are addressed. Further prospective studies with therapeutic drug monitoring are needed to establish standardized protocols.

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Coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF) has high efficacy and improved renal and bone safety in multiple phase 3 trials; TAF single agent is being studied in 2 phase 3 trials in patients with chronic hepatitis B. We report the results of an open-label, noncomparative switch study evaluating the efficacy and safety of E/C/F/TAF in HIV/hepatitis B virus (HBV)-coinfected adults. At 48 weeks, 91.7% of the 72 participants maintained or achieved virologic suppression (HIV-1 RNA <50 copies/mL; HBV DNA <29 IU/mL). Seroconversion occurred in 2.9% of hepatitis B surface antigen-positive participants and in 3.3% of HBV e antigen-positive participants; 40% of those with abnormal alanine aminotransferase normalized. E/C/F/TAF was associated with improved renal function and reduced bone turnover. These data support the use of E/C/F/TAF in treating HIV/HBV coinfection.

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OBJECTIVE: To evaluate the evolution of weight and lipid profiles before and after switch to co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) among virally suppressed HIV-positive patients. METHODS: Patients switching to E/C/F/TAF between March and July 2018 were included. Weight, lipid profile (triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C)), and glycated hemoglobin (HbA1c) levels at 48 weeks before and after the switch were analyzed using generalized estimating equations in order to identify the associated factors. RESULTS: A total of 693 patients were included, and a weight gain was noted after the switch at weeks 12 (mean +0.63 kg), 24 (+1.25), 36 (+1.58), and 48 (+1.75) (all p < 0.0001). The weight change after the switch was significantly greater than that observed within the preceding 48-week period before the switch (+1.75 kg vs +0.54, p < 0.0001) and was correlated with switch to E/C/F/TAF (coefficient 0.29), later clinic visit (0.15), baseline weight (0.99), diabetes mellitus (coefficient -0.96), and age (-0.02) (all p < 0.01). At week 48, significant increases were observed for TG (mean +62.93 mg/dl), TC (+22.30), LDL-C (+9.70), HDL-C (+3.65) (all p < 0.01), and HbA1c (+0.08%) (p < 0.05), but not TC/HDL-C ratio (+0.12, p = 0.38). CONCLUSIONS: Virally suppressed HIV-positive patients gained a moderate amount of weight and had significant increases in lipid levels after switching to E/C/F/TAF.

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Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide as a maintenance therapy showed durable and high rates of viral suppression for HIV/HBV-coinfected patients, with only 5.1% and 2.2% of patients having HBV DNA of ≥20 IU/mL and HIV RNA of ≥50 copies/mL, respectively, at 96 weeks. Our study fills the data gap on the long-term clinical effectiveness of tenofovir alafenamide-containing antiretroviral therapy in people living with HIV who have HBV coinfection.

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HIV post- exposure prophylaxis (PEP) is a prevention tool for individuals with a recent potential exposure to HIV. Doravirine has been available since 2019 in combination with tenofovir disoproxil fumarate and lamivudine and has not been evaluated as a PEP. DOR/3TC/TDF is our department's most commonly prescribed PEP treatment since 2021. This study evaluates the completion rate of the DOR/3TC/TDF as compared to EVG/c/FTC/TAF for PEP, which was the regimen prescribed until 2020 in our hospital.This retrospective observational study was conducted between January 2020 and September 2021. The subjects included consecutively were adults who consulted for an HIV sexual exposure accident and for whom DOR/3TC/TDF in 2021 or EVG/c/FTC/TAF in 2020 was prescribed. The outcomes were the completion rate to the end of treatment (28 days), the seroconversion rate, and the description of side effects.During the study period, 311 people were included: 140 treated with DOR/3TC/TDF and 171 treated with EVGc/FTC/TAF. Considering subjects with a follow-up visit, the completion rate was 96.8% (90/93) in the DOR/3TC/TDF group, and 94.6% (123/130) in the EVG/c/FTC/TAF group (p-value: 0.53). The number of people lost to follow-up was nearly equivalent in both groups: 27.1% (38/140) in the DOR/3TC/TDF group and 23.4% (40/171) in the EVG/c/FTC/TAF group (p-value: 0.45). A side effect was described for 38% (36/94) in the DOR/3TC/TDF group, and 29.7% (38/128) in the EVG/c/FTC/TAF group. No cases of seroconversion were observed.DOR/3TC/TDF appears to have a similar safety profile to EVG/c/FTC/TAF. Due to its lower cost, it seems to be a treatment option for consideration in the context of HIV-exposure accidents.

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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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