- |||||||||| Journal: Major role of dolutegravir in the emergence of the S147G integrase resistance mutation. (Pubmed Central) - Mar 4, 2025
In this French study, S147G emerged principally in patients on dolutegravir regimens, in association with up to five other INSTI resistance mutations. This accumulation of mutations suggests a replicative advantage on HIV strains under dolutegravir selection pressure, suggesting that caution is required when interpreting dolutegravir resistance in the presence of such S147G resistance patterns, even in patients prescribed dolutegravir twice daily.
- |||||||||| Incident Diabetes Among People With HIV After Switching to Integrase Strand Transfer Inhibitors (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_1369;
Conclusions Switching from an NNRTI or PI to an INSTI was associated with an increased risk of incident DM in this diverse cohort of PWH from multiple sites across North America. These findings inform antiretroviral prescribing and tailored risk-benefit approach for PWH, especially those with clinical concern for new-onset DM.
- |||||||||| GS-1720 / Gilead
In Vitro Resistance Profile for GS-1720, a Potent Once-Weekly Oral InSTI in Clinical Development (Poster Hall) - Mar 3, 2025 - Abstract #CROI2025CROI_534; Conclusions GS-1720 exhibits an in vitro resistance profile comparable to the best-in-class INSTI bictegravir, including high barrier to resistance and minimal cross-resistance within the INSTI class. These observations support the ongoing clinical development of GS-1720 as a novel once-weekly oral INSTI.
- |||||||||| bictegravir (GS-9883) / Gilead, Vemlidy (tenofovir alafenamide) / Gilead, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Preclinical, Journal: A dual-purpose humanized mouse model for testing antiviral strategies against both SIV and HIV. (Pubmed Central) - Nov 19, 2024 Infected mice showing chronic viremia were treated with a combination anti-retroviral treatment (cART) regimen consisting of emtricitabine/elvitegravir/tenofovir disoproxil fumarate (FTC/EVG/TDF)...Next, a cART regimen consisting of emtricitabine/bictegravir/tenofovir alafenamide fumarate (FTC/BIC/TAF) was similarly evaluated...These findings highlight the utility of humanized mice for in vivo screening of new combinations of ARV compounds against various SIVs prior to employing them in NHPs. In addition to identifying new effective cART regimens against SIVs, this model would also be amenable to evaluating immunotherapeutic strategies using broadly neutralizing antibodies, LRAs and novel therapeutics in comparative cure studies of SIV and HIV.
- |||||||||| tenofovir disoproxil fumarate / Generic mfg.
Profiles of cardiac, liver, renal, musculoskeletal, and pancreatic safety in virologically suppressed people with HIV?1 switching to tenofovir DF?containing, ainuovirine?based antiretroviral regimen: the secondary analyses of 48?week results of the SPRINT trial, a randomised, active?controlled phase III study (Virtual) - Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_474; Switches to ANV/3TC/TDF and EVG/c/FTC/TAF were both well tolerated in virologically suppressed PWHs. Liver and renal function tests showed an improving trend with both regimens, without clinically significant changes in cardiac, musculoskeletal and pancreatic measures observed.
- |||||||||| Vemlidy (tenofovir alafenamide) / Gilead, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Favourable cholesterol profile in virologically suppressed people with HIV?1 switching to tenofovir DF? containing, ainuovirine?based compared to tenofovir alafenamide?containing, boosted elvitegravir? based antiretroviral regimen: normocholesterolemic subgroup analyses of the SPRINT trial, a randomised, active?controlled phase III study (Virtual) - Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_455; Background: In the SPRINT trial, virologically suppressed people with HIV-1 (PWHs) switched to tenofovir DF (TDF) containing, ainuovirine (ANV, ACC008) based or tenofovir alafenamide (TAF) containing, boosted elvitegravir (EVG/c) based antiretroviral (ARV) regimen (comparator) from an efavirenz-based regimen. In PWHs with baseline normocholesterolaemia, switching to a TDF-containing, ANV-based regimen resulted in less LDL-C increase and better lipidaemic control compared to a TAF-containing, EVG/c-based regimen.
- |||||||||| Vemlidy (tenofovir alafenamide) / Gilead, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Immunological efficacy and early response in virologically suppressed people with HIV?1 switching to tenofovir DF?containing, ainuovirine?based compared to tenofovir alafenamide?containing, boosted elvitegravir?based antiretroviral regimen: secondary immunological efficacy analyses of the SPRINT trial, a randomized, active?controlled phase III study (Virtual) - Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_185; Immunological efficacy was comparable between virologically suppressed PWHs, switching to ANV/3TC/TDF and those to EVG/c/FTC/TAF, few of whom were severely immunocompromised at baseline. However, switch to ANV/3TC/TDF resulted in a favourable early immunological response within the first 12 weeks of switch, compared to that to EVG/c/FTC/TAF.
- |||||||||| Antiretroviral therapy in pregnancy in England in 2019?2022: common regimens and treatment modifications () - Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_130;
Among pregnancies conceived on ART, most common (reported in >5%) first regimens were efavirenz (EFV) + tenofovir disoproxil fumarate (TDF) + emtricitabine (FTC) (13.5% [267/1974]), rilpivirine (RPV) +TDF+FTC (11.6% [228/1974]), darunavir/ritonavir (DRV/r) +TDF+FTC (8.0% [158/1974]), dolutegravir (DTG) + lamivudine (3TC) + abacavir (ABC) (7.7% [152/1974]), and raltegravir (RAL) +TDF+FTC (6.4% [127/1974]). Where ART was initiated during pregnancy (55.7% [234/420] diagnosed antenatally), median gestational age at start was 15 weeks (IQR 12
- |||||||||| Tybost (cobicistat) / Gilead, Vitekta (elvitegravir) / Japan Tobacco, Gilead
P3 data, Journal, Head-to-Head: Switch to fixed-dose ainuovirine, lamivudine, and tenofovir DF versus elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in virologically suppressed people living with HIV-1: the 48-week results of the SPRINT trial, a multi-centre, randomised, double-blind, active-controlled, phase 3, non-inferiority trial. (Pubmed Central) - Aug 2, 2024 In virologically suppressed PLWH on previous NNRTI-based ARV regimen, switch to ANV/3TC/TDF resulted in less weight gain, and improved lipid metabolism while maintaining virological suppression non-inferior to that to EVG/Cobi/FTC/TAF. Jiangsu Aidea Pharmaceutical & the National "Thirteenth Five-year Period" Major Innovative Drugs Research and Development Key Project of the People's Republic of China Ministry of Science and Technology.
- |||||||||| Retrospective data, Journal: Antiretroviral therapy among people with HIV with comorbidities in the United States: a retrospective cohort study. (Pubmed Central) - Jun 24, 2024
The most commonly used anchor agents, 62.6%, were integrase strand transfer inhibitors (INSTIs): dolutegravir (30.4%), elvitegravir (24.2%), and raltegravir (7.3%)...From our analyses, ART prescribing did not appear to vary with the presence of comorbidities and potential medication contraindications. ART regimens may have comparable efficacy profiles; however, selection should be guided by each patient's comorbidities to prevent potential comedication drug toxicities.
- |||||||||| Vitekta (elvitegravir) / Japan Tobacco, Gilead
Specific defects of immature B cells in secondary recombination drive autoantibody production in immune thrombocytopenia (Exhibition Hall) - May 17, 2024 - Abstract #ISTH2024ISTH_1285; Our results showed that in peripheral B cells of ITP patients, the clone types and diversities of Ig heavy chains are diminished, the usage of downstream IGK variable and upstream IGK joining genes is increased, and the V-J distance in immunoglobulin kappa-chain genes is reduced. Employing single-cell antibody cloning technique, we found high-frequency platelet-reactive na
- |||||||||| Vitekta (elvitegravir) / Japan Tobacco, Gilead
Noninferior efficacy, reduced weight gain, and improved lipid metabolism of switch to ainuovirine- versus boosted elvitegravir-based regimen in virologically suppressed people living with HIV-1: 48-week results of the SPRINT trial???? (Poster board: 086) - May 2, 2024 - Abstract #AIDS2024AIDS_1349; 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.
- |||||||||| Vitekta (elvitegravir) / Japan Tobacco, Gilead
Preclinical, Journal: Preclinical and Early Clinical Development of Tenofovir Alafenamide/Elvitegravir Topical Inserts for Effective On-Demand Vaginal and Rectal HIV Prevention. (Pubmed Central) - Mar 28, 2024 In this review, we have described the development path of the TAF/EVG insert up to its current point in clinical testing, highlighting findings from acceptability, preclinical safety, pharmacokinetics, and efficacy evaluations and early clinical studies. In summary, the TAF/EVG inserts are stable, easy to manufacture, low-cost, acceptable, and show highly promising preclinical and clinical results for on-demand topical pre- or post-exposure HIV prevention.
- |||||||||| bictegravir (GS-9883) / Gilead, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Journal: Glycemic Control in Patients Living With HIV Initiated on Integrase Inhibitor-Based Three-Drug Antiretroviral Therapy. (Pubmed Central) - Mar 25, 2024 Primarily patients on both elvitegravir-based and bictegravir-based regimens saw the most significant increase in A1C: 0.16% (95% CI, 0.04-0.27; P = 0.006) and 0.39% (95% CI, 0.02-0.76; P = 0.038), respectively. Conclusion and Relevance: Integrase strand-transfer inhibitor-based 3-drug ART was associated with a small but statistically significant increase in A1C over a 2-year period, requiring additional monitoring by clinicians.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Microbe-Drug Interactions Between Antiretrovirals and the Gut Microbiome in HIV Infection (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_1142; This has potential implications in how ART affects the gut microbiome of PLWH and associated microbial metabolic products, which is under further study in the lab. Finally, bacterial communities from stool have the metabolic potential to deplete specific ARVs in vitro, which may be important in the interindividual success of ART for PLWH.
- |||||||||| Associations Between Antiretroviral Therapy and Cardiovascular Events in People With Treated HIV (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_850;
The distribution of ART regimens was 45% INSTI- (14% raltegravir, 40% elvitegravir, 30% dolutegravir, and 16% bictegravir), 39% NNRTI-, and 16% PI-based regimen. In this large-scale study using U.S. claims databases, PI-based and INSTI-based regimens were associated with higher risk of MACE compared to NNRTI-based regimens after ART initiation, and the pattern of association between INSTIs and PIs with excess risk of MACE was similar.
- |||||||||| First Trimester Exposure to Newer Antiretroviral Agents and Congenital Anomalies in a US Cohort (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_769;
The odds of congenital anomalies among infants with first trimester exposure to newer ARVs did not differ substantially from that among infants unexposed to these specific ARVs. However, modest effects cannot be ruled out, highlighting the need for continued evaluation of these associations in larger populations.
- |||||||||| Antiretroviral Regimens Are Associated With Cognitive Function in People With HIV (Poster hall) - Mar 5, 2024 - Abstract #CROI2024CROI_515;
Tenofovir (including TAF or TDF) and FTC were common in such regimens in combination with either DRV+COBI, RPV, or EFV. Our findings suggest complex associations between ART regimens and cognition, such that specific ART combinations rather than individual agents are associated with cognition.
- |||||||||| Tivicay (dolutegravir) / ViiV Healthcare
Role of Dolutegravir in the Emergence of the S147G Integrase Resistance Mutation (Poster hall) - Mar 5, 2024 - Abstract #CROI2024CROI_475; In such a context it can be associated with up to 6 other INSTI-RM, including T97A and/or N155H in the majority of cases. Thus the S147G mutation needs to be added to the DTG resistance profile in the ANRS algorithm.
- |||||||||| bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
Weight Gain After Initiating ART Close to HIV Seroconversion: Is There a Return to Health Effect? (Poster hall) - Mar 5, 2024 - Abstract #CROI2024CROI_413; As reported in seroprevalent cohorts, Bictegravir and Elvitegravir combined with TAF were associated with the fastest increases in weight. Given that ART was initiated soon after SC, it is unlikely that this is a return to health phenomenon, although the effect of unmeasured confounders can't be disregarded.
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