{"id":3078,"date":"2006-09-09T22:43:12","date_gmt":"2006-09-09T21:43:12","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=3078"},"modified":"2013-12-06T17:02:34","modified_gmt":"2013-12-06T17:02:34","slug":"tenofovirftc-maintains-greater-virological-response-and-reduced-lipoatrophy-compared-to-azt3tc-after-96-weeks","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/3078","title":{"rendered":"Tenofovir\/FTC maintains greater virological response and reduced lipoatrophy compared to AZT\/3TC after 96 weeks"},"content":{"rendered":"

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

Joel Gallant and colleagues presented 96-week data from Gilead\u0092s Phase III study comparing once-daily tenofovir\/FTC to fixed dose twice-daily AZT\/3TC (Combivir) in treatment naive patients starting on efavirenz-based regimens.<\/strong> [1]<\/p>\n

Results from the primary endpoint (virological response <50 copies\/mL at 48 weeks) have already been reported at earlier meetings, and showed advantages in favour of tenofovir\/FTC both virologically (driven by higher discontinuations in the AZT\/3TC group) and with reduced side effects. The 96-week data reported in Toronto maintained similar differences between the two groups, and included results from DEXA scans at week 96.<\/p>\n

Baseline characteristics in the study (ITT, n=509) were similar between arms (median age 37, 14% female, 59% Caucasian, median viral load 5.0 copies\/mL, median CD4 237 cells\/mm3<\/sup>). Excluding patients (n=22) with baseline NNRTI mutations, 76% in TDF+FTC arm (n=244) vs 64% in CBV arm (n=243) achieved and maintained HIV RNA<400 copies\/mL through to week 96 (TLOVR, 95% CI +4.3, +21.1%, p=0.004); 69% in TDF+FTC arm vs. 63% in CBV arm achieved and maintained HIV RNA<50 copies\/mL (95% CI -2.0%, 14.7%, p=0.15). The mean increase in CD4 cell count from baseline was significantly greater in TDF+FTC arm (270 vs 237, p=0.036).<\/p>\n

Adverse events leading to study regimen discontinuation (most common: anemia, nausea, fatigue, vomiting, rash) were fewer for TDF+FTC arm (5%) vs CBV arm (11%), p<0.001. The renal safety profile was also similar in both arms based on serum creatinineand Cokcroft-Gault GFR (p=0.51), but Glomerular Filtration Rate was significantly slightly lower in the tenofovir\/FTC arm (p=0.006).<\/p>\n

At week 96 patients in the tenofovir\/FTC group had significantly greater increases in weight (2.7kg vs 0.5kg, p<0.001). In a subset of patients with DEXA data, median limb fat at week 96 was greater in TDF+FTC arm (7.7 kg, n=144) compared to CBV arm (5.5 kg, n=136), p<0.001.<\/p>\n

In terms of resistance, no patient developed the K65R mutation, and significantly more patients on AZT\/3TC developed M184V\/I (9 vs 2, p=0.037).<\/p>\n

Reference<\/p>\n

    \n
  1. Gallant J, Pozniak A, DeJesus E et al. Efficacy and safety of tenofovir DF (TDF), emtricitabine (FTC) and efavirenz (EFV) compared to fixed dose zidovudine\/lamivudine (CBV) and EFV through 96 weeks in antiretroviral treatment-naive patients. XVI International AIDS Conference, Toronto, Canada. 13-18 August 2006. Poster abstract TUPE0064.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base Joel Gallant and colleagues presented 96-week data from Gilead\u0092s Phase III study comparing once-daily tenofovir\/FTC to fixed dose twice-daily AZT\/3TC (Combivir) in treatment naive patients starting on efavirenz-based regimens. [1] Results from the primary endpoint (virological …<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[151],"class_list":["post-3078","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-aids-16th-toronto-2006"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/3078","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=3078"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/3078\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=3078"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=3078"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=3078"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}