{"id":3063,"date":"2006-09-09T20:52:10","date_gmt":"2006-09-09T19:52:10","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=3063"},"modified":"2013-12-06T17:05:14","modified_gmt":"2013-12-06T17:05:14","slug":"3tcabacavir-maintains-virological-superiority-over-azt3tc-and-aztabacavir-beyond-5-years-in-children","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/3063","title":{"rendered":"3TC\/abacavir maintains virological superiority over AZT\/3TC and AZT\/abacavir beyond 5 years in children"},"content":{"rendered":"

Polly Clayden, HIV i-Base<\/strong><\/p>\n

There are have been few randomised trials in naive children directly comparing ART combinations.Di Gibb presented findings from 5-year follow up of the PENTA 5 trial. This was a 48-week randomised controlled trial comparing three dual NRTI combinations with or without NFV as first line ART therapy.<\/strong><\/p>\n

128 children were randomised, one died and one was lost to follow up within two weeks of randomisation. Asymptomatic children (n=55) were also randomised to NFV or placebo; all other children received open-label NFV. 126 were followed after 48 weeks: AZT+3TC (n=36), AZT+ABC (n=44) or 3TC +ABC (n=46).<\/p>\n

Median follow-up was 5.8 years (range: 3.1-7.8 years) and only 18 children (14%) had less than 5 years follow up. The authors reported 94% AIDS-free survival at 5 years in all arms.<\/p>\n

The investigators found that, as expected, the proportion of child-time taking randomised antiretroviral drugs decreased over time. Between 2.5 to 5 years the proportion of children still taking their randomised NRTIs was lower in both AZT groups: AZT\/3TC 61%, AZT\/ABC 54% and 3TC\/ABC, 69%.<\/p>\n

By 5 years, 63\/126 children (50%) were still taking randomised NRTIs; 19 (53%) AZT\/3TC, 16 (36%) AZT\/ABC and 28 (61%) 3TC\/ABC. However, 18% (3\/17) AZT\/3TC, 50% (14\/28) AZT\/ABC and 50% (9\/18) 3TC\/ABC of the changes from randomised NRTIs were either early single drug substitutions for toxicity (<24 weeks after randomisation) or switches in children for viral suppression (HIV-1 RNA <400 copies\/ml) for simplification, toxicity or carer\/child request.<\/p>\n

At year five viral load data were available for 105 children and 62% (65\/105) of children were <400copies\/mL. Of these 55%\/32% AZT+3TC ; 50%\/25% AZT+ABC; and 79%\/63% 3TC\/ABC had VL <400\/<50 copies\/ml respectively (p=0.03\/p=0.003).<\/p>\n

There were corresponding decreases in log10 VL: 2.3, 2.5 and 3.4 respectively (p=0.001). The mean increase in CD4% was 12%, 9% and 12% (p=0.2); height-for-age 0.42, 0.68 and 1.05 (p=0.02); weight-for-age 0.03, 0.13 and 0.75 (p=0.02).<\/p>\n

Reverse transcriptase resistance mutations were different between the arms:<\/p>\n

AZT\/3TC (n=4): 41, 67, 70, 184, 210 and 215; AZT\/ABC (n=6): n=4 maintained wild-type virus, n=2 developed TAMs 41, 67, 70, 210, 215, 219; 3TC\/ABC (n=6): 65, 74, 115, 184.<\/p>\n

Of the 24 children randomised to dual NRTI only, 0\/7 AZT\/3TC, 3\/11 AZT\/ABC and 4\/6 3TC\/ABC were still taking only 2 drugs at year 5 (0, 1, and 3 with VL <400 copies\/ml).<\/p>\n

Dr Gibb concluded that 3TC\/ABC sustained long term virological superiority; the short-term benefits in terms of growth persisted and lower rates of switching with detectable viral load were observed compared to the other two NRTI backbones.<\/p>\n

She also noted that this backbone can be taken once daily in children >3years and once again made the case for a \u0093combined scored baby pill.\u0094<\/p>\n

Reference:<\/p>\n

Gibb DM, Green H, Saidi Y et al. 3TC +ABC maintains virological superiority over ZDV+3TC and ZDV+ABC beyond 5 years in children. Oral abstract WEAB0302.<\/p>\n","protected":false},"excerpt":{"rendered":"

Polly Clayden, HIV i-Base There are have been few randomised trials in naive children directly comparing ART combinations.Di Gibb presented findings from 5-year follow up of the PENTA 5 trial. This was a 48-week randomised controlled trial comparing three dual …<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,32],"tags":[151],"class_list":["post-3063","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-paediatric-care","tag-aids-16th-toronto-2006"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/3063","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=3063"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/3063\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=3063"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=3063"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=3063"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}