{"id":15961,"date":"2011-12-01T13:31:03","date_gmt":"2011-12-01T13:31:03","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=15961"},"modified":"2013-09-30T06:50:35","modified_gmt":"2013-09-30T06:50:35","slug":"raltegravir-achieves-superiority-over-efavirenz-after-four-years","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/15961","title":{"rendered":"Raltegravir achieves superiority over efavirenz after four years"},"content":{"rendered":"

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

Four year results from a five year, double-blind, randomised, non-inferiority study comparing raltegravir to efavirenz (each with tenofovir plus FTC) in treatment-naive patients were presented by Jurgen Rockstroh.<\/p>\n

The study design, matched baseline characteristics and safety and efficacy results from earlier analyses have already been presented at earlier meetings. The new subgroup analyses (including baseline CD4 <200 copies\/mm3, viral load >100,000 copies\/mL, hepatitis and demographic responses) focused on virological efficacy with discontinuations related to viral failure included but discontinuations for other reasons excluded and using an observed failure approach.<\/p>\n

From approximately 280 patients in each arm at baseline, 223 (79%) and 197 (70%) completed the 192 week analysis, in the raltegravir and efavirenz arms respectively. Discontinuations were all less frequent in the raltegravir arm: virological failure (n=5 vs 8); side effects (n=13 vs 26); and loss to follow-up (n=8 vs 17)<\/p>\n

At 192 weeks, the primary analysis of viral suppression to <50 copies\/mL (non-completer=failure) saw raltegravir achieve statistical superiority compared to efavirenz [76% vs 67% (difference = +9.0; 95%CI 1.6, 16.4, p < 0.001: with the lower limit for non-inferiority set at ?12% and superiority being achieved when both confidence intervals became greater than 1.0].<\/p>\n

CD4 increases were + 60 cells\/mm3 higher in the raltegravir arm (95%CI 24, 95).<\/p>\n

Overall clinical events (96% vs 98%, p = 0.16), discontinuations due to drug-related events (5% vs 8%, p = 0.173) and serious adverse events (18% in each arm, p = 0.91) were similar between the two study groups, raltegravir was associated with significantly fewer drug-related events (50% vs 80%, p < 0.001).<\/p>\n

There were no statistically significant differences in response between groups by gender, age, race\/ethnicity, viral load >100,000 c\/mL, CD4 > 200 cells\/mm3, hepatitis coinfection or HIV sub-type. Raltegravir showed a significantly stronger virological response in the <100,000 c\/mL group (93% vs 81%; difference +12; 95% CI 3, 22). Interpretation of a difference in favour of raltegravir when baseline CD4 was 50-<200 cells\/mm3 is complicated by a trend to favour efairenz when CD4 counts were <50 cells\/mm3.<\/p>\n

comment<\/h2>\n

These results support durability and safety of raltegravir. they also show that after week 192 raltegravir achieves superiority compared to efavirenz with the difference largely driven by efavirenz-related side effects. <\/strong><\/p>\n

The CD4 difference may also be important for patients with sub-optimal CD4 responses on other HAART combinations.<\/strong><\/p>\n

Reference:<\/p>\n

Rockstroh JK et al. Long-term efficacy of raltegravir or efavirenz combined with TDF\/FTC in treatment-na? HIV-1-infected patients: week-192 subgroup analyses from STARTMRK. 13th EACS, 12?15 October 2011, Belgrade. Abstract PS 1\/1.<\/p>\n","protected":false},"excerpt":{"rendered":"

Simon Collins, HIV i-Base Four year results from a five year, double-blind, randomised, non-inferiority study comparing raltegravir to efavirenz (each with tenofovir plus FTC) in treatment-naive patients were presented by Jurgen Rockstroh. The study design, matched baseline characteristics and safety …<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[73],"class_list":["post-15961","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-eacs-13th-2011"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/15961","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=15961"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/15961\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=15961"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=15961"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=15961"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}