A5089696217- HIV/AIDS drug development and treatment
- HIV Research and Treatment
- HIV-related health complications and treatments
- HIV/AIDS Research and Interventions
- Hepatitis C virus research
- Hepatitis B Virus Studies
- Maternal Mental Health During Pregnancy and Postpartum
- COVID-19 Impact on Reproduction
- Neurological and metabolic disorders
- Chronic Lymphocytic Leukemia Research
- Adipose Tissue and Metabolism
- COVID-19 and Mental Health
- Child and Adolescent Health
- Pneumocystis jirovecii pneumonia detection and treatment
- Thermoregulation and physiological responses
- Pharmacological Effects and Toxicity Studies
Gilead Sciences (United States)
2013-2025
National Hospital Organization
2023
Nagoya Medical Center
2023
University of Colorado Hospital
2011-2012
University of Colorado Denver
2011-2012
BackgroundBictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single-tablet regimen recommended for HIV-1 treatment. The safety and efficacy of B/F/TAF as initial therapy was established in two Phase 3 studies: 1489 (vs dolutegravir [DTG]/abacavir/lamivudine) 1490 DTG + F/TAF). After 144 weeks randomized follow-up, an open-label extension evaluated to 240 weeks.MethodsOf 634 participants B/F/TAF, 519 completed the double-blinded treatment, 506/634 (80%) chose 96-week extension,...
Remdesivir is efficacious for severe coronavirus disease 2019 (COVID-19) in adults, but data pregnant women are limited. We describe outcomes the first 86 with COVID-19 who were treated remdesivir.The reported span 21 March to 16 June 2020 hospitalized polymerase chain reaction-confirmed acute respiratory syndrome 2 infection and room air oxygen saturation ≤94% whose clinicians requested remdesivir through compassionate use program. The intended treatment course was 10 days (200 mg on day 1,...
Objective: To evaluate the efficacy and safety of antiretroviral simplification from a ritonavir-boosted protease inhibitor-based regimen [protease inhibitor+RTV+two nucleos(t)ide reverse transcriptase inhibitors (NRTIs); ≥6 months exposure prior to study entry with no treatment failure] single-tablet (STR) rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF) in virologically suppressed, HIV-1-infected participants. Design: Phase 3b, randomized, open-label, international,...
ABSTRACT Lenacapavir is a novel, first-in-class, multistage inhibitor of HIV-1 capsid function approved for the treatment multidrug-resistant infection in combination with other antiretrovirals heavily treatment-experienced people HIV. Two Phase 1, open-label, parallel-group, single-dose studies assessed pharmacokinetics (PK) lenacapavir participants moderate hepatic impairment [Child–Pugh–Turcotte (CPT) Class B: score 7–9] or severe renal [15 ≤ creatinine clearance (CLcr) ≤29 mL/min] to...
A key factor to the successful treatment of HIV is good adherence antiretroviral therapy (ART). We developed a pharmacist-managed clinic and designed study assess impact interventions by measuring proportion patients with 95% or greater ART before after referral program. providers referred problems clinic. Interventions included scheduled visits Clinical Pharmacist monthly refill reminders from pharmacy staff members over 6-month period. Those aged 18-75, prescribed an regimen for minimum 3...
Abstract BRAAVE (NCT03631732), a Phase 3b, multicenter, open‐label US study, demonstrated the efficacy of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) among Black individuals with suppressed HIV through 48 weeks. Here, 72‐week resistance, adherence, and virologic outcomes are presented. Enrollment criteria permitted nonnucleoside reverse transcriptase inhibitor (NNRTI)–resistance (R), protease (PI)–R, certain nucleos(t)ide (NRTI)–R (M184V/I allowed; ≥3 thymidine...
Objective: The objective of this study was to assess the pharmacokinetics, safety, and efficacy confirm dose once-daily bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF; B/F/TAF) during pregnancy. Design: An open-label, multicenter, single-arm, phase 1b (NCT03960645) conducted in 33 virologically suppressed pregnant women with HIV-1. Methods: Participants received B/F/TAF (50/200/25 mg) from second or third trimester through ∼16 weeks postpartum. Steady-state maternal plasma...
Abstract Background An increasing proportion of people with HIV (PWH) are aged ≥ 50 years, a greater burden age-related comorbidities; however, long-term analyses this population limited. We present key treatment outcomes through 5 years first-line therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in PWH vs < years. Methods Studies 1489 (NCT02607930; B/F/TAF dolutegravir/abacavir/lamivudine [DTG/ABC/3TC]) and 1490 (NCT02607956; DTG+F/TAF) were randomized, double-blind,...
Abstract Background Black communities are disproportionately affected by HIV and may have a greater lifetime risk of comorbidities compared with non-Black people (PWH). Despite this, they historically been underrepresented in clinical studies. Here, we report efficacy safety through 5 years first-line therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) PWH. Methods Studies 1489 (NCT02607930; B/F/TAF vs dolutegravir/abacavir/lamivudine [DTG/ABC/3TC]) 1490 (NCT02607956;...
Background: The phase 3 randomized, active-controlled GS-US-380-1844 (NCT02603120) study evaluated switching to the single-tablet regimen bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) from dolutegravir (DTG), abacavir (ABC), lamivudine (3TC) among people with HIV-1. Previously, results 48-week double-blind showed that B/F/TAF was noninferior remaining on DTG/ABC/3TC well tolerated. Here, we show long-term safety efficacy of Methods: Participants were virologically...
Black and Hispanic/Latine people are disproportionately affected by HIV-1 may have a greater risk of comorbidities than non-Black non-Hispanic/Latine with HIV. However, they historically been underrepresented in HIV clinical studies. We aimed to assess the efficacy safety first-line antiretroviral therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) over 5 years present two post hoc pooled analyses participants who received B/F/TAF up week 240 studies 1489 (NCT02607930) 1490...
Abstract Background To evaluate long-term changes in weight and metabolic parameters people with HIV-1 (PWH) initiating first-line antiretroviral therapy. Methods Analysis of two Phase 3, randomized, double-blind, active-controlled trials (1489: NCT02607930; 1490: NCT02607956). PWH received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) or dolutegravir (DTG)-based treatment (Study 1489: dolutegravir/abacavir/lamivudine [DTG/ABC/3TC]; Study DTG + F/TAF) for 144 weeks, followed by...
Transient viremia can occur in people with human immunodeficiency virus (HIV), often referred to as HIV (PWH), and is sometimes related poor adherence antiretroviral therapy (ART). Guidelines recommend achieving virologic resuppression existing ART regimens while addressing the reasons for lack of control. However, there are limited clinical trial data on effectiveness strategy continuing same regimen treatment-experienced PWH following a period viremia. This was post hoc pooled analysis...
Objective: To evaluate the efficacy and safety of 96 weeks bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) treatment in participants switching from dolutegravir (DTG)-based therapy. Design: Studies 1489 (NCT02607930) 1490 (NCT02607956) were phase 3 randomized, double-blind, active-controlled, first-line therapy trials people with HIV-1. After 144 DTG-based or B/F/TAF treatment, could enter a 96-week open-label extension (OLE) B/F/TAF. Methods: A pooled analysis evaluated viral...
Abstract Objective Five Phase 3 bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) clinical studies demonstrated that the efficacy of B/F/TAF was non-inferior to dolutegravir (DTG) + 2 NRTIs. We retrospectively assessed drug adherence and effect on virologic outcomes. Methods Studies (NCT02607930, NCT02607956, NCT03547908, NCT02603120 NCT03110380) were double-blind, placebo-controlled enrolled treatment-naïve or virologically suppressed adults. Adherence calculated by pill count from...
Background: In the phase 3 ALLIANCE study, both bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and dolutegravir plus emtricitabine/tenofovir disoproxil fumarate (DTG + F/TDF) achieved high rates of HIV-1 RNA suppression through week 96 in adults with hepatitis B virus initiating treatment (NCT03547908). this we quantify preexisting resistance, evaluate its effect on virologic suppression, describe postbaseline resistance 96. Methods: Preexisting was assessed by historical and/or...
Raltegravir, an inhibitor of the human immunodeficiency virus‐1 (HIV‐1) integrase enzyme, is a preferred component antiretroviral regimens for both treatment‐naïve and ‐experienced patients. Compared with other agents, raltegravir has less toxicity fewer drug interactions since it not substrate, inhibitor, or inducer cytochrome P450 enzymes. However, devoid interactions. We describe 39‐year‐old, HIV‐1‐infected man who experienced virologic failure while receiving raltegravir‐containing...
Abstract Background Adherence to daily oral antiretroviral therapy is important for sustaining HIV suppression. B/F/TAF Studies 1489, 1490, 4458, 1844 and 4030 demonstrated the noninferior efficacy of versus DTG + 2 nucleoside reverse transcriptase inhibitors (NRTIs). We retrospectively assessed drug adherence effect on virologic outcomes. Methods All studies were double-blind, placebo-controlled, enrolled treatment-naïve (1489, 4458) or virologically suppressed (1844, 4030) adults....
Background: Biktarvy use is currently approved for HIV-1 infection in treatment-naïve and treatmentexperienced individuals after a series of successful investigator-sponsored phase III trials.However, studies on real-world evidence its efficacy, safety, tolerability are limited.Method: This review used the PRISMA extension scoping reviews checklist as framework.The final search strategy was: (Bictegravir* OR biktarvy) AND (efficac* safe* effect* tolerab* "side effect*" "adverse effect*").The...
Tenofovir disoproxil fumarate (TDF), a nucleotide reverse transcriptase inhibitor used in the treatment of human immunodeficiency virus (HIV) and hepatitis B, is renally eliminated has been associated with renal toxicities. Dose adjustments are recommended for patients creatinine clearance (CrCL) <50 mL/min. We retrospectively determined frequency which HIV clinic providers adjusted TDF doses CrCL mL/min over 2-year period compared clinical outcomes who had dose based on versus those did...
This is a plain-language summary of an article that reported on two studies the medication bictegravir/emtricitabine/tenofovir alafenamide (shortened to B/F/TAF). B/F/TAF single pill containing three different drugs used treat human immunodeficiency virus (known as HIV). The work together lower levels HIV (called viral load) in body and make undetectable blood. Researchers measured whether was safe effective when taken over 5 years 400 people 10 countries who had never before.