{"id":42118,"date":"2022-03-01T07:43:03","date_gmt":"2022-03-01T07:43:03","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=42118"},"modified":"2022-09-12T07:44:46","modified_gmt":"2022-09-12T07:44:46","slug":"biktarvy-b-f-taf-5-year-follow-up-in-two-phase-3-studies","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/42118","title":{"rendered":"CROI 2022: Biktarvy (B\/F\/TAF): 5-year follow-up in two phase 3 studies"},"content":{"rendered":"

Kirk Taylor, HIV i-Base<\/strong><\/p>\n

\"CROISingle tablet regimen B\/F\/TAF (bictegravir\/emtricitabine\/TAF) is one of the leading first line combinations in US guidelines.<\/strong><\/p>\n

CROI 2022 included a poster reporting combined 5-year follow-up in two phase 3 studies in treatment na\u00efve individuals that either excluded HBV positive (GS-US-380-1489) or included those with HBV and\/or HCV (GS-US-380-1490).<\/p>\n

Participants from studies 1489 and 1490 (n=506) continued onto a 96-week open label extension to evaluate on-treatment 5-year safety and efficacy. [1]<\/p>\n

There were 62 discontinuations from the combined studies up to week 240 (11% and 13%, respectively). These were reported as due to: participant decision (22), loss to follow up (28), death (1), protocol violation (1), side effects (4), investigator decision (3), low adherence (2) and lack of efficacy (1).<\/p>\n

Participants were recruited form multiple centres (USA, UK, Europe, Canada, Australia, Dominican Republic and Puerto Rico) with median age 31 (range: 18 to 71), the proportion of women was low at 9% (1489) and 13% (1490), 33% were Black or African-American, whilst 24% were Hispanic\/Latinx. Median body weight was 77 kg (IQR: 68 to 88 kg) and HIV-1 viral load was matched at entry.<\/p>\n

Over 97% of participants achieved the primary endpoint of undetectable viral load (<50 copies\/mL) by week 48.<\/p>\n

Median CD4 counts increased by 313 cells\/mm3<\/sup> (IQR: 179 to 475) and 331 cells\/mm3<\/sup> (IQR: 215 to 467) for participants on 1489 and 1490, respectively. Criteria for resistance testing were met for nine people but neither NRTI nor INSTI resistance were detected.<\/p>\n

Low-grade adverse events were commonly reported and included diarrhoea (19% and 24%), headache (16% and 21%) and nasopharyngitis (18% and 19%), all in 1489 and 1490 respectively. Less than 1% of participants (n=5) withdrew from the study due to grade 3-4 adverse events linked to B\/F\/TAF.<\/p>\n

Renal function testing demonstrated an initial decline of eGFR, consistent with previous reports with bictegravir (due to inhibition of tubular secretion of creatinine). No adverse renal events were reported.<\/p>\n

Fasting lipid levels were modestly increased over five years with no change in TC:HDL.<\/p>\n

Minimal details were included for weight changes although median cummulative weight gain was +6.1 kg. Increases after the first year were reported as comparable to the general population (0.3 to 1.5 kg\/year).<\/p>\n

Spine and hip bone mineral densities did not decrease beyond 2% across the study period, with a mean decrease of 0.29% at week 240.<\/p>\n

The study concluded that these data provide important long-term safety and efficacy data for B\/F\/TAF.<\/p>\n

References<\/p>\n

    \n
  1. Wohl et al. B\/F\/TAF Five-year outcomes in treatment-naive adults. CROI 2022. 12-16 February 2022, virtual. Poster abstract 494.
    \nhttps:\/\/www.croiconference.org\/abstract\/b-f-taf-five-year-outcomes-in-treatment-naive-adults<\/a><\/li>\n
  2. Pharmacokinetics and full phase 2 results for bictegravir, a new integrase inhibitor. (HTB 27 February 2017).
    \n    https:\/\/i-base.info\/htb\/31239<\/a><\/li>\n<\/ol>\n

    This report was first published on 14 February 2022.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

    Kirk Taylor, HIV i-Base Single tablet regimen B\/F\/TAF (bictegravir\/emtricitabine\/TAF) is one of the leading first line combinations in US guidelines. CROI 2022 included a poster reporting combined 5-year follow-up in two phase 3 studies in treatment na\u00efve individuals that either …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[318],"class_list":["post-42118","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-croi-2022"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/42118","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=42118"}],"version-history":[{"count":1,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/42118\/revisions"}],"predecessor-version":[{"id":44067,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/42118\/revisions\/44067"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=42118"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=42118"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=42118"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}