2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/2iy5wruuedsh6.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/00yc7rcvua6a7.js","/_next/static/immutable/chunks/37ktb71aq3480.js","/_next/static/immutable/chunks/2d50b-7eu4558.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/2d6noqpp6ehas.js","/_next/static/immutable/chunks/1sx186c93bpzg.js","/_next/static/immutable/chunks/3dc-1n866s65i.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2w1bvggzb0ga8.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:T6f6,Tenofovir alafenamide (TAF) is a key component of many fixed-dose combinations used to treat HIV. There are limited data on the pharmacokinetics of plasma tenofovir alafenamide (TAF), tenofovir (TFV), or intracellular tenofovir diphosphate (TFV-DP), among people with HIV (PWH) and tuberculosis (TB) who are taking rifampicin-based TB treatment. Participants in the intervention arm of the INSIGHT trial (NCT04734652) receiving bictegravir/emtricitabine/TAF (BIC/FTC/TAF 50/200/25mg) were enrolled into the semi-intensive pharmacokinetic sub-study. BIC/FTC/TAF was administered twice-daily during rifampicin-based TB treatment (∼24 weeks) and once-daily thereafter. Plasma (TAF/TFV) and dried blood spot samples (TFV-DP) were collected at weeks 4 and 12 (pre-dose, 1, 2, 4, 6, and 8-12h post-dose) during TB treatment and at week 32 (pre-dose, 1, 2, 4, 6-8 and 24-25h post-dose) post-TB treatment. Pharmacokinetic parameters were determined using non-compartmental analysis. Clinical and safety data were collected. Among 43 participants enrolled; median (IQR) age and weight were 35 (30-39) years and 58 (52-65) kg; 77% were male. Geometric least square mean ratios (90% CI) at week 12 (twice-daily TAF) relative to week 32 (once-daily TAF) for TAF AUC0-4, TFV and TFV-DP AUC0-24 were 1.55 (1.13-2.13), 1.24 (1.07-1.44), and 1.32 (1.13-1.53), respectively. At week 24, 95% of participants achieved viral suppression, with no treatment-related serious adverse events or drug discontinuations. Twice-daily TAF was safe and efficacious and achieved similar exposures of intracellular TFV-DP in PWH taking rifampicin for TB compared to once-daily TAF taken alone. These data support the use of TAF in a fixed-dose combination of BIC/FTC/TAF during rifampicin-containing TB treatment.31:T972,Abstract Background Tenofovir alafenamide (TAF) is a key component of many fixed-dose combinations used to treat HIV. There are limited data on the pharmacokinetics of plasma tenofovir alafenamide (TAF), tenofovir (TFV), or intracellular tenofovir diphosphate (TFV-DP), among people with HIV (PWH) and tuberculosis (TB) who are taking rifampicin-based TB treatment. Methods Participants in the intervention arm of the INSIGHT trial (NCT04734652) receiving bictegravir/emtricitabine/TAF (BIC/FTC/TAF 50/200/25mg) were enrolled into the semi-intensive pharmacokinetic sub-study. BIC/FTC/TAF was administered twice-daily during rifampicin-based TB treatment (∼24 weeks) and once-daily thereafter. Plasma (TAF/TFV) and dried blood spot samples (TFV-DP) were collected at weeks 4 and 12 (pre-dose, 1, 2, 4, 6, and 8-12h post-dose) during TB treatment and at week 32 (pre-dose, 1, 2, 4, 6-8 and 24-25h post-dose) post-TB treatment. Pharmacokinetic parameters were determined using non-compartmental analysis. Clinical and safety data were collected. Results Among 43 participants enrolled; median (IQR) age and weight were 35 (30-39) years and 58 (52-65) kg; 77% were male. Geometric least square mean ratios (90% CI) at week 12 (twice-daily TAF) relative to week 32 (once-daily TAF) for TAF AUC0-4, TFV and TFV-DP AUC0-24 were 1.55 (1.13-2.13), 1.24 (1.07-1.44), and 1.32 (1.13-1.53), respectively. At week 24, 95% of participants achieved viral suppression, with no treatment-related serious adverse events or drug discontinuations. Conclusion Twice-daily TAF was safe and efficacious and achieved similar exposures of intracellular TFV-DP in PWH taking rifampicin for TB compared to once-daily TAF taken alone. These data support the use of TAF in a fixed-dose combination of BIC/FTC/TAF during rifampicin-containing TB treatment. 32:Tdd2,To date, clinical trials have been underpowered to assess which antiretrovirals perform best in people with advanced HIV disease. We aimed to investigate the efficacy and safety of an integrase inhibitor-containing versus a boosted protease inhibitor-containing regimen for this population. In this open-label, multicentre, non-inferiority trial in seven European countries (Spain, France, Italy, Germany, Belgium, Ireland, and the UK), therapy-naive adults with advanced HIV disease were randomly allocated (1:1) to receive either bictegravir, emtricitabine, and tenofovir alafenamide (integrase inhibitor group) or darunavir, cobicistat, emtricitabine, and tenofovir alafenamide (boosted protease inhibitor group) for 48 weeks. Randomisation was computer generated in permuted blocks within strata with block sizes of four and stratified by country and baseline CD4 cell count. The primary composite outcome (time to first occurrence of specified virological or clinical events) and its components were evaluated by Kaplan-Meier and Cox regression analyses in both modified intention-to-treat (mITT) and per-protocol populations. The mITT population included all randomly allocated participants who received at least one dose of the study drug, whereas the per-protocol population excluded those who received incorrect treatment. Non-inferiority of the integrase inhibitor-based regimen versus the boosted protease inhibitor-containing regimen was declared if the upper limit of the 95% CI of the hazard ratio (HR) for the primary composite endpoint was less than 1·606, corresponding to a 12% difference in the cumulative probability of the composite primary endpoint. Adverse events, a secondary endpoint, were recorded at eight visits in all participants. This trial is registered with ClinicalTrials.gov, NCT03696160, and is completed. Between May 13, 2019, and June 26, 2023, 222 people were randomly assigned to the integrase inhibitor group and 225 to the boosted protease inhibitor group. Of these 447 recruited participants, 442 (99%) participants with a median CD4 count of 41 cells per μL (IQR 17-79) received at least one dose. 358 (81%) of the 442 treated participants self-reported as male and 84 (19%) female, and 276 (62%) were of White ethnicity, 83 (19%) Black, and 83 (19%) other. In the mITT analysis, the 48-week composite primary outcome event occurred in 49 (22%) of 220 participants in the integrase inhibitor group versus 70 (32%) of 222 participants in the boosted protease inhibitor group (adjusted HR 0·70 [95% CI 0·48-1·00]; non-inferiority shown). The per-protocol analysis gave a similar estimated adjusted HR of 0·69 (0·48-1·00; non-inferiority shown). By mITT, drug-related adverse events (grade ≥2) occurred in 16 (7%) of 220 participants in the integrase inhibitor group versus 32 (14%) of 222 in the boosted protease inhibitor group (p=0·043). The rates of serious adverse events or adverse events leading to study discontinuation did not differ between groups. 12 deaths occurred during the study (nine in the integrase inhibitor group and three in the boosted protease inhibitor group), not related to the study drugs. In people with advanced HIV disease, bictegravir, emtricitabine, and tenofovir alafenamide was shown to be non-inferior to darunavir, cobicistat, emtricitabine, and tenofovir alafenamide and resulted in fewer adverse events, supporting its use as a preferred first-line antiretroviral regimen in this vulnerable population. Gilead Sciences and Janssen Pharmaceuticals.25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"bictegravir: generic Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on bictegravir (generic). Clinician-written summaries and actionable practice insights. 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Viral suppression (<50 copies/mL) was achieved in 93.4% vs. 92.4%, and discontinuations due to adverse events were low and similar (2.0% vs. 1.7%).","limitations":"- Switch trial only (virologically suppressed patients on B/F/TAF); generalizability to treatment-naïve or previously failing patients is unknown.\n- Primary endpoint is at week 48; 96-week durability data not yet reported.\n- Recruited predominantly from existing B/F/TAF users, limiting diversity of prior treatment histories.","practice_takeaway":"Once-weekly oral ISL/LEN is a viable, noninferior alternative to daily B/F/TAF for virologically suppressed adults and may improve adherence through reduced dosing frequency. Clinicians can consider it as a switch option for stable patients seeking a less burdensome regimen."}},{"doi":"10.1093/ofid/ofag471","pmid":null,"title":"VOGUE: Non-Inferior Efficacy of Dolutegravir/Lamivudine Versus Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-1 Naive to Treatment","journal_title":"Open Forum Infectious Diseases","journal_issn":"2328-8957","published_at":"2026-07-28T00:00:00.000Z","url":"https://doi.org/10.1093/ofid/ofag471","source_score":12,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":false,"crossref":true,"unpaywall":true},"created_at":"2026-07-31T13:37:05.241Z","updated_at":"2026-07-31T13:37:05.241Z","tags":[{"paper_doi":"10.1093/ofid/ofag471","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"brand","value":"Biktarvy","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"brand","value":"Dovato","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"category","value":"Immunology","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"condition","value":"HIV-1 Infection","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"generic","value":"bictegravir","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"generic","value":"bictegravir/emtricitabine/tenofovir alafenamide","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"generic","value":"dolutegravir","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"generic","value":"dolutegravir/lamivudine","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"generic","value":"emtricitabine","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"generic","value":"lamivudine","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"generic","value":"tenofovir alafenamide","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"modality","value":"Antiretroviral Therapy","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"modality","value":"Integrase Strand Transfer Inhibitor","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"sample_size","value":"n=509","value_numeric":509},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"warning","value":"Baseline resistance testing was not completed before treatment initiation, which may have influenced virologic withdrawal rates in a real-world context.","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"warning","value":"Open-label design is a notable methodological limitation; blinding was not feasible given the different pill counts and regimens. Clinicians should interpret the 3% absolute difference cautiously, as the confidence interval nearly touches the non-inferiority margin of -10%.","value_numeric":null},{"paper_doi":"10.1093/ofid/ofag471","tag_type":"warning","value":"The brand name for dolutegravir/lamivudine (Dovato) is inferred from the drug combination; the paper does not explicitly state the brand name.","value_numeric":null}],"summaries":{"what_studied":"Phase 3b randomized open-label non-inferiority trial comparing the 2-drug regimen dolutegravir/lamivudine (DTG/3TC) vs. the 3-drug regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as first-line ART in 509 treatment-naive adults with HIV-1, including those with high viral loads (≥100,000 copies/mL, 47%) and low CD4+ counts (<200 cells/mm³, 16%), through 48 weeks.","key_result":"DTG/3TC was non-inferior to BIC/FTC/TAF: HIV-1 RNA <50 copies/mL at Week 48 was achieved in 89% vs. 92%, respectively (adjusted difference −3% [95% CI −8%, 2%]). Median time to virologic suppression was 4.1 weeks in both arms. Confirmed virologic withdrawals were equal (n=7 each), and no treatment-emergent resistance was detected in either group through Week 48.","limitations":"- Open-label design may introduce outcome assessment bias.\n- 48-week follow-up may not capture longer-term resistance emergence or durability differences.\n- Resistance testing results were unavailable at treatment initiation, so some participants may have had undetected baseline resistance.","practice_takeaway":"DTG/3TC (a 2-drug regimen) can be offered as initial ART across a broad range of patients, including those with high viral loads or low CD4+ counts, without sacrificing virologic efficacy compared to BIC/FTC/TAF. The absence of treatment-emergent resistance through 48 weeks supports its use even before resistance testing results are available."}},{"doi":"10.1093/cid/ciaf732","pmid":"41467354","title":"Pharmacokinetics of Twice-Daily Tenofovir Alafenamide In Adults with HIV-Associated TB on BIC/FTC/TAF and Rifampicin","journal_title":"Clinical Infectious Diseases","journal_issn":"1058-4838","published_at":"2025-12-30T00:00:00.000Z","url":"https://doi.org/10.1093/cid/ciaf732","source_score":8,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2026-01-03","doi":"10.1093/cid/ciaf732","days":"7","issn":"1058-4838","rank":"10","field":"Clinical Medicine","score":"8","category":"Infectious Diseases","categories":["Infectious Diseases"],"_categories":["Infectious Diseases"]},"pubmed":{"doi":"10.1093/cid/ciaf732","title":"Pharmacokinetics of Twice-Daily Tenofovir Alafenamide In Adults with HIV-Associated TB on BIC/FTC/TAF and Rifampicin.","journal":"Clinical infectious diseases : an official publication of the Infectious Diseases Society of America","methods":"","results":"Among 43 participants enrolled; median (IQR) age and weight were 35 (30-39) years and 58 (52-65) kg; 77% were male. Geometric least square mean ratios (90% CI) at week 12 (twice-daily TAF) relative to week 32 (once-daily TAF) for TAF AUC0-4, TFV and TFV-DP AUC0-24 were 1.55 (1.13-2.13), 1.24 (1.07-1.44), and 1.32 (1.13-1.53), respectively. At week 24, 95% of participants achieved viral suppression, with no treatment-related serious adverse events or drug discontinuations.","abstract":"$30","keywords":["HIV","Pharmacokinetics","Rifampicin","Tenofovir alafenamide","Tuberculosis","drug-interactions"],"pubmed_id":"41467354","conclusions":"Twice-daily TAF was safe and efficacious and achieved similar exposures of intracellular TFV-DP in PWH taking rifampicin for TB compared to once-daily TAF taken alone. These data support the use of TAF in a fixed-dose combination of BIC/FTC/TAF during rifampicin-containing TB treatment.","publication_date":"2025-12-30T00:00:00"},"crossref":{"DOI":"10.1093/cid/ciaf732","URL":"https://doi.org/10.1093/cid/ciaf732","ISSN":["1058-4838","1537-6591"],"link":[{"URL":"https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciaf732/66151332/ciaf732.pdf","content-type":"application/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciaf732/66151332/ciaf732.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":null,"type":"journal-article","issue":null,"score":1,"title":["Pharmacokinetics of Twice-Daily Tenofovir Alafenamide In Adults with HIV-Associated TB on BIC/FTC/TAF and Rifampicin"],"author":[{"given":"Emmanuella Chinonso","family":"Osuala","sequence":"first","affiliation":[{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal , Durban ,"}]},{"given":"Ivan Nicholas","family":"Nkuhairwe","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town , Cape Town ,"}]},{"given":"Marothi Peter","family":"Letsoalo","sequence":"additional","affiliation":[{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal , Durban ,"}]},{"given":"Kogieleum","family":"Naidoo","sequence":"additional","affiliation":[{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal , Durban ,"},{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA), South African Medical Research Council (SAMRC)-CAPRISA-TB-HIV Pathogenesis and Treatment Research Unit, University of KwaZulu-Natal Nelson R Mandela School of Medicine , Durban ,"}]},{"given":"Rubeshan","family":"Perumal","sequence":"additional","affiliation":[{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal , Durban ,"},{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA), South African Medical Research Council (SAMRC)-CAPRISA-TB-HIV Pathogenesis and Treatment Research Unit, University of KwaZulu-Natal Nelson R Mandela School of Medicine , Durban ,"}]},{"given":"James F","family":"Rooney","sequence":"additional","affiliation":[{"name":"Gilead Sciences , Foster City, CA ,"}]},{"given":"Lubbe","family":"Wiesner","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town , Cape Town ,"}]},{"given":"Roeland E","family":"Wasmann","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town , Cape Town ,"}]},{"given":"Paolo","family":"Denti","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine, University of Cape Town , Cape Town ,"}]},{"given":"Kelly E","family":"Dooley","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center , Nashville, Tennessee ,"}]},{"given":"Anushka","family":"Naidoo","sequence":"additional","affiliation":[{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal , Durban ,"},{"name":"Centre for the AIDS Programme of Research in South Africa (CAPRISA), South African Medical Research Council (SAMRC)-CAPRISA-TB-HIV Pathogenesis and Treatment Research Unit, University of KwaZulu-Natal Nelson R Mandela School of Medicine , Durban 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evaluated BIC/FTC/TAF 50/200/25 mg given twice daily during ~24 weeks of TB therapy and once daily afterward, comparing week 12 (BID, on rifampicin) with week 32 (QD, off rifampicin). 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The primary endpoint was time to first specified virological or clinical event, analyzed in modified intention‑to‑treat (mITT) and per‑protocol populations.","key_result":"By 48 weeks (mITT), the composite primary event occurred in 49/220 (22%) with the integrase regimen vs 70/222 (32%) with the boosted protease inhibitor regimen (adjusted HR 0.70, 95% CI 0.48–1.00; non‑inferiority shown). Drug‑related adverse events grade ≥2 were 16/220 (7%) vs 32/222 (14%) (p=0.043); serious adverse events and discontinuations were similar, and there were 12 deaths (9 vs 3), none related to study drugs.","limitations":"Open‑label design. Follow‑up limited to 48 weeks.","practice_takeaway":"In advanced HIV disease, bictegravir/emtricitabine/tenofovir alafenamide was non‑inferior to darunavir/cobicistat/emtricitabine/tenofovir alafenamide and had fewer drug‑related adverse events over 48 weeks, supporting its use as a preferred first‑line regimen in this setting."}}],"initialOffset":4,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"generic","value":"bictegravir"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Generics","href":"/hub/tag/generic"},{"name":"bictegravir"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"generic","hub_tag_value":"bictegravir"}}}]]

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