bictegravir (GS-9883) News

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|||||||||| Incidence of cardiometabolic outcomes among people living with HIV initiated on INSTI versus non-INSTI antiretroviral therapies () - May 12, 2022 - Abstract #AIDS2022AIDS_700;
Among treatment-naïve PWH in the US, INSTI initiation was associated with greater risk of developing congestive heart failure, myocardial infarction, and lipid disorders during a short follow-up period. With increasing life expectancy among PWH, further research including additional clinical variables and using longer follow-up is warranted to examine the impact of INSTI-containing ART on long-term clinical outcomes.

|||||||||| Pifeltro (doravirine) / Merck (MSD), Prezcobix (darunavir/cobicistat) / Gilead, J&J
Reversibility of neuropsychiatric adverse events after switching to darunavir/cobicistat or doravirine in men on INSTI based regimen () - May 12, 2022 - Abstract #AIDS2022AIDS_668;
NPAEs seem to be associated in patients on INSTI based regimen; these NPAEs improve after switching to DRV/c or DOR based regimen since the first 4 weeks. ISI and PHQ-9 are quick, easy, and self-reported questionnaires to test on each visit.

|||||||||| bictegravir (GS-9883) / Gilead
COVID-19 outcomes in patients with cancer and HIV: An analysis of the COVID-19 and Cancer Consortium (CCC19). () - Apr 28, 2022 - Abstract #ASCO2022ASCO_6194;
PWH have characteristics associated with adverse outcomes in prior analyses (male sex, non-Hispanic Black or Hispanic, hematologic malignancy, progressing cancer) but are notably younger and have fewer comorbidities. HIV infection may portend increased risk of severe COVID-19 and death; however, additional analyses, including multivariable regression, are warranted.

|||||||||| bictegravir (GS-9883) / Gilead, Dovato (dolutegravir/lamivudine) / ViiV Healthcare
Journal: Similar CD4/CD8 Ratio Recovery After Initiation of Dolutegravir Plus Lamivudine Versus Dolutegravir or Bictegravir-Based Three-Drug Regimens in Naive Adults With HIV. (Pubmed Central) - Apr 19, 2022
There were no differences between 2DR and 3DR in the incidence ratio of CD4/CD8 ratio normalization at 0.5, 1.0 and 1.5 cut-offs. In this large cohort study in people with HIV, ART initiation with dolutegravir plus lamivudine vs. dolutegravir or bictegravir-based triple antiretroviral therapy showed no difference in the rates of CD4/CD8 normalization at 48 weeks.

|||||||||| bictegravir (GS-9883) / Gilead
Journal: First report of computational protein-ligand docking to evaluate susceptibility to HIV integrase inhibitors in HIV-infected Iranian patients. (Pubmed Central) - Apr 5, 2022
Several analyses were performed including docking screening, genotypic resistance, secondary/tertiary structures, post-translational modification (PTM), immune epitopes, etc. The average docking energy (E value) of different samples with elvitegravir (EVG) and raltegravir (RAL) was more than other INTIs...Some conserved motifs and specific amino acids in INT-protein binding sites have characterized that mutation(s) in them may disrupt INT-drugs interaction and cause a significant loss in susceptibility to INTIs. Good adherence, treatment of naïve patients, and monitoring injection drug users are fundamental factors to control HIV infection in Iran effectively.

|||||||||| bictegravir (GS-9883) / Gilead
Journal: Impact of combinations of clinically observed HIV integrase mutations on phenotypic resistance to integrase strand transfer inhibitors (INSTIs): a molecular study. (Pubmed Central) - Apr 2, 2022
High-level dolutegravir, bictegravir and cabotegravir resistance requires multiple integrase substitutions including compensatory mutations. T97A and E138K further enhance the resistance conferred by G140S/Q148H, yielding >300-fold decreased susceptibility to all INSTIs when all four mutations are present.

|||||||||| Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare, bictegravir (GS-9883) / Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Clinical, Journal: Weight gain in treatment-naive HIV-1 infected patients starting abacavir/lamivudine/dolutegravir or tenofovir alafenamide/emtricitabine/bictegravir. (Pubmed Central) - Mar 26, 2022
T97A and E138K further enhance the resistance conferred by G140S/Q148H, yielding >300-fold decreased susceptibility to all INSTIs when all four mutations are present. No abstract available

|||||||||| New P4 trial: META-D: The Effect on Lipid Profile of Switching to Delstrigo in HIV Positive Patients (clinicaltrials.gov) - Mar 21, 2022
P4, N=60, Not yet recruiting, Sponsor: Chelsea and Westminster NHS Foundation Trust

|||||||||| bictegravir (GS-9883) / Gilead
Review, Journal: Use of integrase inhibitors in HIV-associated tuberculosis in high-burden settings: implementation challenges and research gaps. (Pubmed Central) - Mar 15, 2022
Ongoing and planned studies will address some critical questions on the use of INSTIs in settings with a high tuberculosis burden, including dosing of dolutegravir, bictegravir, and cabotegravir when used with the rifamycins for both tuberculosis treatment and prevention. Failure, in the past, to include people with tuberculosis in HIV clinical treatment trials has been responsible for some of the research gaps still evident for informing optimisation of HIV and tuberculosis co-treatment.

|||||||||| bictegravir (GS-9883) / Gilead
Clinical, PK/PD data, Journal: Bictegravir pharmacokinetics in a late-presenting HIV-1-infected pregnant woman: a case report. (Pubmed Central) - Mar 5, 2022
Failure, in the past, to include people with tuberculosis in HIV clinical treatment trials has been responsible for some of the research gaps still evident for informing optimisation of HIV and tuberculosis co-treatment. No abstract available

|||||||||| bictegravir (GS-9883) / Gilead
Preclinical, Journal: In vitro analysis of the replicative capacity and phenotypic susceptibility to integrase inhibitors of HIV-2 mutants with integrase insertions. (Pubmed Central) - Mar 4, 2022
These first data on the newly described resistance pathway 231ins, using site-directed mutagenesis, showed no measurable impact on viral fitness and confirmed the decreased susceptibility to a first-generation INSTI (raltegravir) and cabotegravir. Resistance to second-generation INSTIs (dolutegravir and bictegravir) occurred for mutants with a 5 amino acid 231ins.

|||||||||| Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare, bictegravir (GS-9883) / Gilead, Descovy (emtricitabine/tenofovir alafenamide) / Gilead
Clinical, Journal: Early discontinuation of DTG/ABC/3TC and BIC/TAF/FTC single-tablet regimens: a real-life multicenter cohort study. (Pubmed Central) - Feb 26, 2022
PLWH who received DTG or BIC do not show differences in VF or EDAC rates. However, EDAEs is more frequent with DTG especially in the over-sixties and in those who come from regimens without abacavir.

|||||||||| Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare, bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
Journal: An up-to-date evaluation of dolutegravir/abacavir/lamivudine for the treatment of HIV. (Pubmed Central) - Feb 26, 2022
Bictegravir with tenofovir alafenamide and emtricitabine offers the benefit of same day initiation and efficacy in hepatitis B co-infection, while new two-drug regimens enhance the simplicity of HIV treatment. Continued study is required into the mechanisms and optimal management strategies for weight gain for many regimens, including DTG/ABC/3TC.

|||||||||| bictegravir (GS-9883) / Gilead
Retrospective data, Journal: Effects of different integrase strand transfer inhibitors on body weight in patients with HIV/AIDS: a network meta-analysis. (Pubmed Central) - Feb 11, 2022
Continued study is required into the mechanisms and optimal management strategies for weight gain for many regimens, including DTG/ABC/3TC. According to the data analysis, among the existing INSTIs, DTG may be the drug that causes the most significant weight gain in HIV/AIDS patients, followed by BIC.

|||||||||| bictegravir (GS-9883) / Gilead
Review, Journal: Weight Changes With Integrase Strand Transfer Inhibitor Therapy in the Management of HIV Infection: A Systematic Review. (Pubmed Central) - Feb 9, 2022
Within the INSTI class, dolutegravir and bictegravir may be associated with the greatest risk for weight gain particularly when combined with tenofovir alafenamide. Further research is needed to determine mechanisms for observed weight changes and any contributions to clinically significant metabolic and cardiovascular adverse outcomes associated with INSTI therapy.

|||||||||| bictegravir (GS-9883) / Gilead
SOME InSTIs INDUCE TOXICITY AND DIFFERENTIATION IN HUMAN EMBRYONIC STEM CELLS ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_1193;
Our objective was to characterize the effects of four InSTIs in two human embryonic stem cell (hESC) lines, with respect to markers of pluripotency, early differentiation, and cellular healt H9 and CA1S hESCs (n=6 and n=3 independent experiments, respectively) were exposed to DTG, cabotegravir (CAB), bictegravir (BIC), or raltegravir (RAL) at doses ranging from 0.01X to 1X peak plasma drug concentrations (Cmax) or DMSO diluent control...Given their use in first-line ARV regimens, including by women of reproductive age or pregnant, it is imperative to elucidate their long-term safety in the context of pregnancy and embryonic development. These data also indicate that RAL appears to show a safe profile, a reassuring finding that warrants further investigation.

|||||||||| bictegravir (GS-9883) / Gilead
TRANSMITTED DRUG RESISTANCE TO INTEGRASE-BASED FIRST-LINE TREATMENT IN EUROPE ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_1123;
Here we describe the most recent data on transmitted drug resistance to integrase based first line regimens in Mediterranean Europe. Given the low prevalence of clinically relevant resistance to second generation integrase inhibitors and to first line NRTIs, in the years 2018-2021 it is very unlikely that a newly diagnosed patient in MeditRes countries would present with baseline resistance to a first line regimen based on second generation integrase inhibitors.

|||||||||| bictegravir (GS-9883) / Gilead
CHARACTERIZING MECHANISMS OF TRANSCRIPTIONAL CONTROL IN HIV-INFECTED MACROPHAGES ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_1010;
The inability of known LRAs to reactivate chronically infected macrophages supports the possibility that transcriptional control in myeloid cells is mechanistically distinct from T-cell latency. These differences will need to be considered when designing therapies to address the persistent reservoir.

|||||||||| bictegravir (GS-9883) / Gilead
ADIPOCYTE DIFFERENTIATION AND ANTIRETROVIRAL DRUGS: AN IN VITRO MODEL ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_666;
Our results confirm that INSTIs could increase adipogenesis, while, on the other hand, in our 3T3L1 cells in vitro model of adipogenesis, TAF shows an inhibitory effect, being able to effectively contrast the increased adipogenesis caused by other INSTIs, in particular DTG and BIC. Taken together, these evidences are suggestive for an antagonistic effect on adipocyte differentiation by different antiretroviral drugs routinely used in therapeutic association.

|||||||||| bictegravir (GS-9883) / Gilead
PHARMACOGENETICS OF WEIGHT GAIN AFTER SWITCH TO INTEGRASE INHIBITOR-BASED REGIMENS ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_662;
In a prior study of 101 PWH who switched from efavirenz (EFV)- to INSTI-based ART, CYP2B6 genotypes (which predict higher plasma EFV levels) were associated with greater post-switch weight gain...174 eligible participants switched ART from 2007 to 2019, with 80 normal, 75 intermediate, and 19 poor CYP2B6 metabolizers; 147 males and 27 females; 93 White, 51 Black, and 27 Hispanic participants; 70 switched to dolutegravir (DTG), 55 to raltegravir (RAL), 41 to elvitegravir (EVG), and 8 to bictegravir...CYP2B6 poor metabolizer genotype was associated with greater weight gain after switch from EFV- to INSTI-based ART, but results were inconsistent. Weight gain in this setting is likely complex and multifactorial.

|||||||||| bictegravir (GS-9883) / Gilead
2DR VS 3DR INTEGRASE INHIBITOR-BASED REGIMENS INITIATION AND CD4+/CD8+ RATIO RECOVERY ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_630;
This study provides new evidence that CD4/CD8 ratio recovery rates are similar during the first 48 weeks after ART initiation with 2DR or 3DR INSTI-based therapies. Next studies should address the potential long-term differences between these strategies.

|||||||||| bictegravir (GS-9883) / Gilead
REVERSIBILITY OF CENTRAL NERVOUS SYSTEM ADVERSE EVENTS IN COURSE OF ART ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_613;
Central nervous system (CNS) adverse events (AE) can occur during various antiretroviral therapies (ART), as well as being a major cause of treatment discontinuation during dolutegravir-containing ART (DTG)...Sixty SNC-AE leading to ART discontinuation were reported, 26/3613 (0.7%) in non DTG-cohorts (2/731 lopinavir, 1/616 atazanavir, 2/721 darunavir, 8/421 rilpivirine, 5/514 raltegravir, 3/339 elvitegravir and 5/211 bictegravir), and 34/1138 (3.1%) in DTG-cohort...AE leading to ART discontinuation were more frequent in DTG than non-DTG treated PLWH. However, most AE resolved after ART switch, with similar frequency in DTG and non-DTG cohorts.

|||||||||| bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
PHARMACOKINETICS OF DOLUTEGRAVIR AND BICTEGRAVIR IN OBESE PEOPLE LIVING WITH HIV ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_542;
PBPK modelling is a useful tool to overcome limited clinical data. Our predictions verified with clinical data indicate that obesity has a modest effect on the pharmacokinetics of dolutegravir and bictegravir which does not warrant a dosage adjustment in this special population.

|||||||||| bictegravir (GS-9883) / Gilead
Journal: HIV Pretreatment Drug Resistance Trends in Mexico City, 2017-2020. (Pubmed Central) - Dec 29, 2021
PDR to dolutegravir/bictegravir remained low in Mexico City, although further surveillance is warranted given the short time of ART optimization. Our study identifies demographic characteristics of groups with higher risk of PDR and lost to follow-up, which may be useful to design differentiated interventions locally.

|||||||||| bictegravir (GS-9883) / Gilead
PK/PD data, Review, Journal: Pharmacokinetic drug interactions of integrase strand transfer inhibitors. (Pubmed Central) - Dec 16, 2021
While raltegravir undergoes biotransformation by the UDP-glucuronosyltransferases (UGTs), elvitegravir is primarily metabolized by cytochrome P450 (CYP) 3A4 and co-formulated with cobicistat to increase its plasma exposure...Also, common geriatric challenges such as multimorbidity and polypharmacy have been increasingly recognized in PWH. This review provides a summary of pharmacokinetic interactions with INSTIs and future perspectives in implications of INSTI drug interactions.

|||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare, bictegravir (GS-9883) / Gilead, Isentress (raltegravir) / Merck (MSD)
Clinical, Journal: High-level resistance to bictegravir and cabotegravir in subtype A- and D-infected HIV-1 patients failing raltegravir with multiple resistance mutations. (Pubmed Central) - Dec 16, 2021
This review provides a summary of pharmacokinetic interactions with INSTIs and future perspectives in implications of INSTI drug interactions. Though not currently widely accessible in most LMICs, bictegravir and cabotegravir offer a valid alternative to HIV-infected individuals harbouring subtype A and D HIV-1 variants with reduced susceptibility to first-generation INSTIs but previous exposure to raltegravir may reduce efficacy, more so with cabotegravir.

|||||||||| bictegravir (GS-9883) / Gilead
Bictegravir in the Elderly Living with HIV: Impact of Polypharmacy and Multimorbidity ([VIRTUAL]) - Dec 2, 2021 - Abstract #ASHP2021ASHP_2379;

|||||||||| bictegravir (GS-9883) / Gilead
Clinical, PK/PD data, Journal: Physiologically based pharmacokinetic modelling to support the clinical management of drug-drug interactions with bictegravir. (Pubmed Central) - Dec 2, 2021
Importantly, the inducing effect of rifampicin on bictegravir was predicted to be reversed with the concomitant administration of a strong inhibitor such as ritonavir, resulting in a DDI magnitude within the efficacy and safety margin for bictegravir (0.5-2.4-fold). In conclusion, the PBPK modelling strategy can effectively be used to guide the clinical management of DDIs for novel drugs with limited clinical experience, such as bictegravir.

|||||||||| bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
Of course this integrase inhibitor drug class was just getting started. Look at on-treatment responses today using dolutegravir and bictegravir-containing regimens. And this with no treatment-emergent resistance 11/x (Twitter) - Nov 21, 2021

|||||||||| bictegravir (GS-9883) / Gilead
Clinical, PK/PD data, Journal: First pharmacokinetic data of bictegravir in pregnant women living with HIV. (Pubmed Central) - Nov 16, 2021
In conclusion, the PBPK modelling strategy can effectively be used to guide the clinical management of DDIs for novel drugs with limited clinical experience, such as bictegravir. No abstract available

|||||||||| bictegravir (GS-9883) / Gilead
PK/PD data: First pharmacokinetic data of bictegravir in pregnant women: AIDS. Looks like fixed dose TAF/FTC/BIC daily dosing might not be enough in this population due to low trough (comparable to BIC bid+RIF level). https://t.co/xLA6Vka0hW @sigal_md (Twitter) - Nov 13, 2021

|||||||||| bictegravir (GS-9883) / Gilead
Clinical, Review, Journal, Adverse events: Comparative safety review of recommended, first-line single-tablet regimens in patients with HIV. (Pubmed Central) - Nov 5, 2021
Integrase inhibitors (InsTIs)-based regimens have few interruptions for adverse events and few drug-related adverse events, with tenofovir alafenamide/emtricitabine/dolutegravir and lamivudine/dolutegravir being the most tolerable ones. However, neuropsychiatric adverse events and metabolic issues could prompt the alternative use of darunavir or doravirine-based combinations, even if a superior safety profile of these combinations over InSTIs has yet to be demonstrated.

|||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare, bictegravir (GS-9883) / Gilead
Preclinical, Journal: HIV-1 non-group M phenotypic susceptibility in vitro to bictegravir and cabotegravir. (Pubmed Central) - Oct 29, 2021
However, neuropsychiatric adverse events and metabolic issues could prompt the alternative use of darunavir or doravirine-based combinations, even if a superior safety profile of these combinations over InSTIs has yet to be demonstrated. This study has shown encouraging results regarding the clinical use of these drugs in HIV-1/non-M-infected patients, which will need to be confirmed with clinical data.

|||||||||| bictegravir (GS-9883) / Gilead
Clinical: OFID’s 2nd October Case of the Month looks at a case of treatment-emergent resistance to bictegravir in a person recently diagnosed with HIV: https://t.co/4GKt3xks8v #IDSAJournals @PaulSaxMD @DrJLi @UMMC_ID (Twitter) - Oct 27, 2021

|||||||||| bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
Clinical, Journal, HEOR: Dolutegravir in Mexico for special populations: A cost analysis perspective. (Pubmed Central) - Oct 27, 2021
They include raltegravir (RAL), elvitegravir/cobicistat (EVG/c), dolutegravir (DTG) and bictegravir (BIC)...This is partially due to the increase in the pre-treatment resistance to non-nucleoside reverse transcriptase inhibitors (NNRTI), mainly efavirenz (EFV)...Tuberculosis is a common coinfection in Mexico that requires rifampin-based anti-tuberculosis therapy, which requires increasing DTG to double dosing (50 mg BID). In Mexico, DTG-based regimens are likely to be cost-effective in many scenarios, given its acquisition costs and the particularities of the HIV population and associated clinical conditions, including a relatively high proportion of the following: i) new HIV diagnoses presenting at acquired immunodeficiency syndrome (AIDS) stage; ii) high rate of tuberculosis coinfection; iii) frequent first-line NNRTI treatment failures; and iv) relatively high proportion of infected children and adolescents.

|||||||||| bictegravir (GS-9883) / Gilead
Review, Journal: HIV-1 integrase strand transfer inhibitors: A review of current drugs, recent advances and drug resistance. (Pubmed Central) - Oct 22, 2021
Considering the increasing interest in INSTIs for HIV-1 treatment, we focus our review on the retroviral integrase, development of INSTIs and their mode of action. We also discuss each of the INSTI drugs, including potential drug resistance and known side effects.

|||||||||| bictegravir (GS-9883) / Gilead
Clinical: OFID’s 2nd October Case of the Month looks at a case of treatment-emergent resistance to bictegravir in a person recently diagnosed with HIV: https://t.co/4GKt3xC3x5 #IDSAJournals @PaulSaxMD @DrJLi @UMMC_ID (Twitter) - Oct 22, 2021

|||||||||| bictegravir (GS-9883) / Gilead
Clinical: OFID’s 2nd October Case of the Month looks at a case of treatment-emergent resistance to bictegravir in a person recently diagnosed with HIV: https://t.co/z68D25GfAg #IDSAJournals @PaulSaxMD @DrJLi @UMMC_ID (Twitter) - Oct 16, 2021

|||||||||| bictegravir (GS-9883) / Gilead
[VIRTUAL] PRIMARY EFFUSION LYMPHOMA IN A NEWLY DIAGNOSED HIV PATIENT () - Oct 13, 2021 - Abstract #CHEST2021CHEST_2174;
It is reasonable for physicians to include PEL as one of the differentials in patients with serous effusion with an unknown or positive HIV history. Prompt initiation treatment can help improve the chance of survival and the quality of life in such individuals.

|||||||||| bictegravir (GS-9883) / Gilead
Journal: Are New Antiretroviral Treatments Increasing the Risk of Weight Gain? (Pubmed Central) - Oct 13, 2021
Evidence with cabotegravir, the newest integrase inhibitor, is limited...Evidence suggests that the nucleoside reverse transcriptase backbone has additional effects on weight gain, with tenofovir alafenamide potentially enhancing the weight gain effect...New thresholds for weight gain should be established as guidance for clinicians to stop treatment where weight gain is excessive. Novel treatments such as doravirine could offer a suitable therapy alternative, with current evidence showing efficacy with limited effect on weight gain.

|||||||||| bictegravir (GS-9883) / Gilead, Descovy (emtricitabine/tenofovir alafenamide) / Gilead
Clinical, Journal: Short-term neuropsychiatric tolerability of bictegravir combined with emtricitabine/tenofovir alafenamide in clinical practice. (Pubmed Central) - Oct 6, 2021
A pre-existing depression but also physician's awareness may have an impact on tolerability and continuation of BIC/F/TAF. In contrast, prior intolerability of DTG was of limited predictive value.

|||||||||| bictegravir (GS-9883) / Gilead
[VIRTUAL] Trend of Transmitted Resistance Associated Mutations in People Living with HIV (PLWH) in a Large Southeastern U.S. Ryan White Clinic () - Oct 6, 2021 - Abstract #IDWeek2021IDWeek_1802;
This increase in baseline resistance to the INSTI class, which occurred over time, mimics the historical development of RAMs seen in the earlier ART classes. Though suboptimal adherence in the population promotes development of RAMs, increased frequency of INSTI RAMs may be due to a lower barrier to resistance of first generation INSTIs.

|||||||||| bictegravir (GS-9883) / Gilead
[VIRTUAL] Evaluating Weight Gain in Treatment-naïve, HIV-infected Patients Started on Antiretroviral Therapy () - Oct 6, 2021 - Abstract #IDWeek2021IDWeek_1801;
The non-INSTI-based regimens were darunavir (DRV) or rilpivirine (RPV)-based...Of the patients initiated on INSTI-based regimens, 73.5% were on elvitegravir (EVG),16.7% on dolutegravir, 8.8% on bictegravir, and 0.98% on raltegravir... When comparing INSTI-based to DRV or RPV-based regimens, there was no significant increase in average weight at 6 and 18 months.

|||||||||| bictegravir (GS-9883) / Gilead
[VIRTUAL] Evaluation of Association Among Integrase Inhibitors for HIV Treatment, Weight Gain, and Body Image () - Oct 6, 2021 - Abstract #IDWeek2021IDWeek_1798;
Elvitegravir and raltegravir are associated with greater weight gain whereas bictegravir demonstrates weight loss and beneficial effects on lipid profile. Despite weight gain, most patients remained adherent and satisfied with their medication and denied negative perceptions of body image.

|||||||||| bictegravir (GS-9883) / Gilead
[VIRTUAL] Early discontinuations and adverse events among treatment-naïve patients initiating integrase inhibitors in a real-world setting () - Oct 6, 2021 - Abstract #IDWeek2021IDWeek_1797;
In this cohort, early DCs occurred in 11% initiating INSTI-based therapy, however of these only 2% were treatment-related. These data support use of INSTI-based regimens as preferred options for treatment-naïve patients living with HIV due to their favorable safety and tolerability profiles.

|||||||||| bictegravir (GS-9883) / Gilead
[VIRTUAL] The Impact of the COVID-19 Pandemic on Clinical Follow-Up, Monitoring and Regimen Discontinuation for People Living with HIV in the US () - Oct 6, 2021 - Abstract #IDWeek2021IDWeek_1794;
A reduction in regimen discontinuation rates was also observed, presumably associated to less frequent follow-up. The long-term impact of the pandemic on HIV care remains uncertain.

|||||||||| bictegravir (GS-9883) / Gilead
Clinical, PK/PD data, Review, Journal: Comparative Clinical Pharmacokinetics a1 nd Pharmacodynamics of HIV-1 Integrase Strand Transfer Inhibitors: An Updated Review. (Pubmed Central) - Sep 23, 2021
Bictegravir, dolutegravir, and raltegravir are recommended components of initial regimens for most people with HIV in the US adult and adolescent HIV treatment guidelines. This review summarizes and compares the pharmacokinetics and pharmacodynamics of the integrase strand transfer inhibitor agents, and describes specific pharmacokinetic considerations for persons with hepatic impairment, renal dysfunction, pregnancy, and co-infections.

||||||||||  bictegravir (GS-9883) / Gilead, Vemlidy (tenofovir alafenamide) / Gilead
Enrollment change, Trial withdrawal:  A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Bictegravir, Tenofovir Alafenamide and Rifapentine in Healthy Adult Subjects (clinicaltrials.gov) -  Sep 20, 2021
P4, N=0, Withdrawn,  Sponsor: Yale University
This review summarizes and compares the pharmacokinetics and pharmacodynamics of the integrase strand transfer inhibitor agents, and describes specific pharmacokinetic considerations for persons with hepatic impairment, renal dysfunction, pregnancy, and co-infections. N=24 --> 0 | Not yet recruiting --> Withdrawn

|||||||||| bictegravir (GS-9883) / Gilead
Journal: Weight gain before and after switch from TDF to TAF in a U.S. cohort study. (Pubmed Central) - Sep 19, 2021
N=24 --> 0 | Not yet recruiting --> Withdrawn In this large, diverse U.S. cohort of PLWH, switching from TDF to TAF was associated with pronounced weight gain immediately after switch, regardless of the core class or core agent, suggesting an independent effect of TAF on weight gain.

|||||||||| bictegravir (GS-9883) / Gilead
Identification of a treatment-emergent integrase resistance mutation in an HIV late-presenter on first-line therapy (eLibrary) - Sep 18, 2021 - Abstract #EACS2021EACS_865;
Caution is warranted in patients with poor adherence, slow virologic response or important viral load. Drug level monitoring may indicate treatment escalation.



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