Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead 
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  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Bictegravir/emtricitabine/tenofovir alafenamide for the treatment of primary HIV infection: the BIC-PHI clinical trial (Poster board: 098) -  May 2, 2024 - Abstract #AIDS2024AIDS_1348;    
    The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
  • ||||||||||  Switching strategies in older adults with HIV: comparing 2-Drug and 3-Drug Regimens (Poster board: 077) -  May 2, 2024 - Abstract #AIDS2024AIDS_1317;    
    The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Switching to B/F/TAF in a real-world cohort of older people with HIV and a high burden of non-AIDS-related comorbidities (Poster board: 072) -  May 2, 2024 - Abstract #AIDS2024AIDS_1259;    
    The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
    Clinical, Retrospective data, Journal:  Switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir-based therapy: 96-week pooled analysis. (Pubmed Central) -  May 1, 2024   
    P3
    Data support the use of single-tablet coformulated bictegravir (30 mg), emtricitabine (120 mg), and tenofovir alafenamide (15 mg) for treatment of HIV in children aged at least 2 years and weighing 14 kg to less than 25 kg. This medium-term analysis demonstrates the safety and efficacy of switching to B/F/TAF from a DTG-containing regimen in people with HIV-1.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    New P4 trial:  The Antiretroviral Speed Access Program Switch (ASAP-Switch) Study (clinicaltrials.gov) -  Apr 19, 2024   
    P4,  N=50, Not yet recruiting, 
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Enrollment closed, Trial completion date, Trial primary completion date:  INSIGHT: INSTI's For The Management of HIV-associated TB (clinicaltrials.gov) -  Apr 3, 2024   
    P2,  N=122, Active, not recruiting, 
    Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Aug 2024 | Trial primary completion date: Jul 2024 --> Jan 2024
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, GS-5894 / Gilead, GS-1720 / Gilead
    Trial completion date, Trial primary completion date:  Study of Novel Antiretrovirals in Participants With HIV-1 (clinicaltrials.gov) -  Mar 29, 2024   
    P1,  N=110, Recruiting, 
    Previous VF with first-generation integrase strand transfer inhibitors (INSTIs) should be kept in mind when switching patients to second-generation INSTIs. Trial completion date: May 2024 --> Dec 2024 | Trial primary completion date: May 2024 --> Dec 2024
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Trial completion date, Trial primary completion date:  T-DDI: Drug-Drug Interaction Study in Trans Women Living With HIV (clinicaltrials.gov) -  Mar 26, 2024   
    P4,  N=45, Recruiting, 
    Trial completion date: May 2024 --> Dec 2024 | Trial primary completion date: May 2024 --> Dec 2024 Trial completion date: Dec 2023 --> Jan 2025 | Trial primary completion date: Oct 2023 --> Aug 2024
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Immune Reconstitution Inflammatory Syndrome (IRIS)-Associated Hypercalcemia in an HIV/AIDS Patient () -  Mar 23, 2024 - Abstract #NKFSCM2024NKF_SCM_606;    
    Due to worsening hypoxia (requiring 9L/ min of oxygen via nasal cannula) in the setting of severe PJP infection, glucocorticoid therapy was initiated with solumedrol 30mg IV BID, and subsequently tapered as oxygenation improved...Isotonic saline and IV pamidronate were administered and prednisone was increased from 20 mg daily to 40 mg daily... IRIS-associated hypercalcemia in patients with HIV/AIDS should be considered in the differential diagnosis of hypercalcemia.
  • ||||||||||  doravirine/islatravir (MK-8591A) / Merck (MSD)
    Switching to Doravirine/Islatravir Maintains Viral Suppression Regardless of Archived Mutations (Poster hall) -  Mar 16, 2024 - Abstract #CROI2024CROI_1304;    
    P3
    Background: In 2 phase 3 clinical trials, switching to the 2-drug combination doravirine/islatravir (DOR/ISL) 100/0.75mg was non-inferior to continuing the prior antiretroviral (ART) regimen. Switching to DOR/ISL 100/0.75mg maintains viral suppression for up to 96 weeks regardless of archived M184I/V or NNRTI RAMs in proviral DNA.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Longitudinal Analysis of Preexisting Resistance-Associated Mutations Prior to B/F/TAF Switch (Poster hall) -  Mar 16, 2024 - Abstract #CROI2024CROI_1303;    
    Some RAMs were consistently reported, but the majority were newly detected or fluctuated and did not disappear significantly over time, which most likely reflects both the ongoing decay and proliferation of the latent reservoir and, ARV pressure. RAMs were not always detected, and this lack of longitudinal stability enforces the need to consider an individual's treatment history and all past genotyping test results (and the detection sensitivities of reports) for treatment management.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Body Composition Changes Among DMPA and Non-Hormonal Users on TDF Based ART Switched to B/F/TAF (Poster hall) -  Mar 16, 2024 - Abstract #CROI2024CROI_1275;    
    RAMs were not always detected, and this lack of longitudinal stability enforces the need to consider an individual's treatment history and all past genotyping test results (and the detection sensitivities of reports) for treatment management. We assessed the effect of switching women living with HIV (WLWH) from TDF/ lamivudine/ dolutegravir to Bictergravir /Emtricitabine / TAF (B/F/TAF; Biktarvy
  • ||||||||||  Sunlenca (lenacapavir) / Gilead, islatravir (MK-8591) / Merck (MSD)
    Efficacy and Safety of Weekly Islatravir Plus Lenacapavir in PWH at 24 Weeks: A Phase II Study () -  Mar 16, 2024 - Abstract #CROI2024CROI_1164;    
    P2
    In this Phase 2 study, the first QW oral ARV regimen of ISL+LEN maintained viral suppression at W24 and was well tolerated. The ISL 2 mg dose showed no clinically significant decreases in CD4+ T-cell counts or ALCs as were seen previously with higher daily, weekly, and monthly doses of ISL.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Impact of Switch to 3TC/DTG on the HIV-1 Transcriptional Reservoir in a Randomized Controlled Trial (Poster hall) -  Mar 16, 2024 - Abstract #CROI2024CROI_931;    
    Rates of viral suppression were high in both groups. There is no evidence that simplification of a triple ART INI-based regimen to 3TC/DTG impacts the overall size of the reservoir, neither the fraction of intact virus nor the transcriptional activity.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    A Randomized Trial Switching Adults ? 60 Years Old From First-Line ART to B/F/TAF: Week 48 Results (Poster hall) -  Mar 16, 2024 - Abstract #CROI2024CROI_930;    
    There is no evidence that simplification of a triple ART INI-based regimen to 3TC/DTG impacts the overall size of the reservoir, neither the fraction of intact virus nor the transcriptional activity. Switching to B/F/TAF may be effective and safe for virally suppressed adults ?60 years on a TDF containing regimen and is associated with improvement in BMD and fewer requirements for regimen modification due to worsening kidney function.
  • ||||||||||  Dovato (dolutegravir/lamivudine) / ViiV Healthcare, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Impact of Switching From Dual to Triple Therapy on Inflammation: INSTINCT Study (Poster hall) -  Mar 16, 2024 - Abstract #CROI2024CROI_929;    
    P4
    This analysis revealed no significant impact on IL-6 levels when switching from DTG/3TC to BIC/FTC/TAF after 48 weeks. These preliminary findings suggest a neutral inflammatory effect for the ART switch, warranting further study to elucidate the longer-term influence on inflammation.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Factors Associated With HBV Response to B/F/TAF vs DTG + F/TDF at W96 in People With HIV-1 and HBV (Poster hall) -  Mar 16, 2024 - Abstract #CROI2024CROI_881;    
    At Year 2, B/F/TAF was associated with significantly higher rates of HBeAg loss/seroconversion and numerically higher rates of HBsAg loss/seroconversion and ALT normalization compared with DTG+F/TDF in people with HIV-1/HBV. This analysis suggests that the treatment difference of TAF- vs. TDF-based therapy for some or all HBV treatment outcomes may be greater for certain subgroups, such as people <30 years of age, or with baseline HBV DNA <8 log10 IU/mL, HBV genotype B/C or baseline ALT levels above normal.
  • ||||||||||  Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Inflammatory Profile of B/F/TAF, DTG/ABC/3TC, and DTG+F/TAF Over 5 Years and Effects of Viral Blips (Poster hall) -  Mar 16, 2024 - Abstract #CROI2024CROI_831;    
    This analysis suggests that the treatment difference of TAF- vs. TDF-based therapy for some or all HBV treatment outcomes may be greater for certain subgroups, such as people <30 years of age, or with baseline HBV DNA <8 log10 IU/mL, HBV genotype B/C or baseline ALT levels above normal. Viral suppression was associated with significantly reduced inflammation in treatment-na
  • ||||||||||  Estimated Costs of Eliminating Medicaid Prior Authorizations for Antiretrovirals in Washington State (Poster hall) -  Mar 16, 2024 - Abstract #CROI2024CROI_544;    
    PrEP models assumed a 10% annual increase in the number of PrEP users and evaluated the impact of annual declines in the relative percentage of PrEP users on TDF/FTC with compensatory increases in TAF/FTC use; some models assumed the percentage of PrEP users on cabotegravir (CAB) would increase 1% annually...Our No PA Model assumed: 1) 18% annual relative increase in the percentage of PLWH on bictegravir/TAF/FTC; 2) the percentage of people on tenofovir/FTC taking TAF/FTC (vs. TDF/FTC) increases 9% annually; 3) CAB/rilpivirine increases 1% annually; 4) no change in darunavir/cobisistat; and 5) use of other ART drugs decline in proportion to their 2022 use...Elimination of Medicaid PAs will likely result in substantial new costs. Changes in drug formulary policy should consider opportunity costs.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Enrollment open, Trial completion date, Trial primary completion date:  INSIGHT: INSTI's For The Management of HIV-associated TB (clinicaltrials.gov) -  Mar 15, 2024   
    P2,  N=122, Recruiting, 
    A graphical abstract is available with this article. Active, not recruiting --> Recruiting | Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Jan 2024 --> Jul 2024
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME PRESENTING AS RECURRENT SMALL BOWEL OBSTRUCTION; A USUAL SUSPECT IN AN UNUSUAL LOCATION (Hall A, Poster Hall - Walter E. Washington Convention Center) -  Mar 14, 2024 - Abstract #DDW2024DDW_3745;    
    She was diagnosed with HIV/AIDS-associated encephalopathy and discharged on ART (bictegravir, emtricitabine & tenofovir alafenamide) and trimethoprim-sulfamethoxazole prophylaxis...The patient was discharged on pantoprazole 40mg...The patient was treated with high doses of trimethoprim/sulfamethoxazole and prednisone with significant improvement...To our knowledge, this is the first reported case of PJ presenting as IRIS in the small bowel. In the setting of recent initiation of ART, new symptoms and signs should always prompt the consideration of IRIS.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    HIV-1 RNA Blips and Low-Level Viral Replication: SOLAR (CAB+RPV LA vs BIC/FTC/TAF) (Poster hall) -  Mar 5, 2024 - Abstract #CROI2024CROI_491;    
    P3
    The proportions of study participants with HIV-1 RNA viral blips, TND, and HIV-1 RNA <40 c/mL were similar between CAB+RPV LA and BIC/FTC/TAF through Month 12. HIV-1 viral blips with CAB+RPV LA did not appear to be associated with CVF, consistent with prior CAB+RPV LA Phase 3 clinical study data.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Simultaneous Start Strategy With BIC/FTC/TAF in Individuals With HIV/HCV Coinfection in China (Poster hall) -  Mar 5, 2024 - Abstract #CROI2024CROI_453;    
    Immediate initiation or switch to BIC/FTC/TAF with SOF/VEL treatment provided high HIV and HCV suppression rate with a favorable safety profile. The study suggests that HCV treatment can start immediately without waiting for the CD4 T cell count to exceed 200 cells/mm