{"id":32970,"date":"2017-11-28T12:26:54","date_gmt":"2017-11-28T12:26:54","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=32970"},"modified":"2017-11-28T17:29:55","modified_gmt":"2017-11-28T17:29:55","slug":"switching-to-ftaf-is-non-inferior-to-continuing-abc3tc","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/32970","title":{"rendered":"Switch study shows F\/TAF non-inferior to continuing abacavir\/3TC"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/strong><\/p>\n

\"\"Results from the first randomised study comparing FTC\/tenofovir alafenamide (F\/TAF) to continuing on abacavir\/3TC showed little significant differences between the newer vs older dual NRTI combinations, but also no risk from switching.
\n<\/strong><\/p>\n

This was a randomised, double-blind, placebo controlled switching study in 556 participants on ABC\/3TC-based ART, sponsored by Gilead. Week-48 primary endpoint results were presented by Alan Winston from Imperial College, London. Entry criteria included viral suppression <50 copies\/mL on ABC\/3TC-based ART for > 6 months and CrCl > 50 mL\/min.<\/p>\n

Baseline criteria included median age 52 years (range: 20 to 79). 18% women, 73% white, with high CD4 counts (median >650 cells\/mm3<\/sup>). Although renal function was good, with median eCrCl 100 mL\/min (IQR: 83 to 123), approximately half the cohort had hyperlipidaemia, 40% had hypertension, 12% had diabetes and 6% were defined as having cardiovascular disease. Participants had been taking abacavir\/3TC for a median of 8 years (IQR: 3 to 11). The third component of ART was an NNRTI for 50%, with 30% using PI and 20% integrase-based ART.<\/p>\n

By week-48, there were fewer overall discontinuations in the abacavir\/3TC arm (n=18 vs 31; 7% vs 11%), mainly die to higher loss to follow-up or investigation decision (both n= 0 vs 3).<\/p>\n

Viral efficacy <50 copiers\/mL at week-48 was also higher for the abacavir\/3TC group at 93% vs 90% (difference -3.0%; 95%CI: -8.2 to +2.0) but this met the criteria for non-inferiority (based on lower margin of \u201310% cut off).<\/p>\n

Side effects were generally low incidence and grade and closely similar in both groups. Laboratory abnormalities were also similar, including lipid changes.<\/p>\n

However, although changes in estimated creatinine clearance favoured F\/TAF (\u00ad1.1 vs +1.3 mL\/min; p=0.05), there were no significant differences in renal tubular biomarkers or bone mineral density. Small differences in some lipid parameters didn’t results in a significant difference in TC:HDL ratio or in new use of lipid lowering drugs.<\/p>\n

The single death was sudden cardiac event in the F\/TAF arm that was not judged linked to ART.<\/p>\n

Comment<\/h3>\n

This randomised dataset is interesting, even with no expected benefits in renal and bone markers. Further follow-up will continue to week-96.<\/strong><\/p>\n

The difference in cost (approximately 4000 vs 500 Euros a year) was raised in the Q&A session afterwards as likely to limit widespread switching in clinical practice, unless there is concern for cardiovascular risk.<\/strong><\/p>\n

Reference:<\/p>\n

Winston A et al. Phase 3 randomized controlled trial of switching to emtricitabine\/tenofovir alafenamide (F\/TAF) from abacavir\/lamivudine (ABC\/3TC) in virologically suppressed adults: week 48 results. EACS 2017, Milan. Oral abstract PS8\/4.<\/p>\n","protected":false},"excerpt":{"rendered":"

Simon Collins, HIV i-Base Results from the first randomised study comparing FTC\/tenofovir alafenamide (F\/TAF) to continuing on abacavir\/3TC showed little significant differences between the newer vs older dual NRTI combinations, but also no risk from switching. This was a randomised, …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3,41],"tags":[246],"class_list":["post-32970","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","category-treatment-strategies","tag-eacs-16-milan-2017"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/32970","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=32970"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/32970\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=32970"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=32970"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=32970"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}