{"id":2966,"date":"2006-10-07T14:01:29","date_gmt":"2006-10-07T13:01:29","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=2966"},"modified":"2013-12-06T15:49:29","modified_gmt":"2013-12-06T15:49:29","slug":"efavirenztenofovir-fails-as-2-drug-maintenance-regimen","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/2966","title":{"rendered":"Efavirenz\/tenofovir fails as 2-drug maintenance regimen"},"content":{"rendered":"

Mark Mascolini, natap.org<\/strong><\/p>\n

Efavirenz plus tenofovir given as a simplified maintenance regimen did not control HIV as well as the same two drugs plus 3TC in a 48-week French trial<\/strong> [1]. Three people in the two-drug arm and none in the three-drug arm had to stop an antiretroviral because of treatment-related side effects.<\/strong><\/p>\n

Pierre-Marie Girard (St. Antoine Hospital, Paris) and colleagues across France recruited 143 people with a viral load below 50 copies\/mL for at least 6 months on their current regimen, no history of virologic failure, and no significant lab or clinical abnormalities. Study participants were randomised to start efavirenz\/tenofovir or those two drugs plus 3TC.<\/p>\n

The group had a median age of 40 years (range 22 to 73) and a median CD4 count of 473 (range 78 to 1775); 35% had CDC stage C disease. They had taken antiretrovirals for a median of 3.7 years (range 0.5 to 7.7). While 45.5% were taking two nucleosides plus one protease inhibitor, 43.5% were taking a non-nucleoside with two nucleosides. Nearly three quarters (71%) were using AZT and 3TC as their nucleosides.<\/p>\n

After 48 weeks, both intention-to-treat analysis and on-treatment analysis showed better virologic control in the three-drug group (Table 1). The 95% confidence interval for both comparisons stretched beyond the range set to establish non-inferiority of the two-drug regimen (14%).<\/p>\n

Table 1: Two- versus three-drug maintenance for 48 weeks<\/strong><\/p>\n\n\n\n\n\n\n
<\/th>\nEFV\/TDF<\/th>\nEFV+2 RTIs<\/th>\nDifference (upper bound 95% CI)<\/th>\n<\/tr>\n
n<\/td>\n72<\/td>\n71<\/td>\n<\/td>\n<\/tr>\n
Intent-to-treat <50copies\/mL<\/td>\n81.7%<\/td>\n97.2%<\/td>\n15.5% (23.7%)<\/td>\n<\/tr>\n
On treatment <50copies\/mL<\/td>\n90%<\/td>\n100%<\/td>\n10.0% (15.5%)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Three people in the two-drug group had NNRTI-related resistance mutations by week 48, while no NNRTI mutations emerged in the triple-drug group. Ten people in the two-drug arm stopped one or more study drugs, 3 of them because of treatment-related side effects (2 transaminase elevations and 1 case of vertigo). No one in the three-drug arm stopped an antiretroviral because of side effects, though two stopped coming back for follow-up visits.<\/p>\n

Median CD4 counts climbed by 35 cells\/mm3 in the three-drug group and 14 cells in the two-drug group, but this difference lacked statistical significance (p=0.94). Median hemoglobin rose 0.80 g\/dL in the triple-therapy arm and 0.45 g\/dL in the double-therapy arm, a difference that also fell short of significance (P = 0.14). Creatinine clearance fell 3.3 mL\/min in the three-drug arm and rose 1.7 mL\/min in the two-drug arm, again a non-significant difference (p=0.17).<\/p>\n

In the group as a whole, triglycerides fell 0.25 mmol\/L (p<0.001) and total cholesterol fell 0.3 mmol\/L (p<0.001). Dangerous low-density lipoprotein cholesterol dropped 0.2 mmol\/L in the triple-therapy group (p=0.015 versus baseline) but rose (non-significantly) by 0.15 mmol\/L in the two-drug group (p=0.5). The treatment groups did not differ in lipid changes or fat distribution. Subcutaneous abdominal fat rose significantly in the whole study group (9 cm2, p=0.017), while the visceral-to-subcutaneous adipose tissue ratio fell by 0.05 (p=0.06).<\/p>\n

Reference:<\/p>\n

    \n
  1. Girard PM, Cabie A, Michelet C, et al. Tenofovir DF + efavirenz vs tenofovir DF + efavirenz + lamivudine maintenance regimen in virologically controlled patients: COOL trial. 46th ICAAC. September 27-30, 2006, San Francisco. Abstract H-1383.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Mark Mascolini, natap.org Efavirenz plus tenofovir given as a simplified maintenance regimen did not control HIV as well as the same two drugs plus 3TC in a 48-week French trial [1]. Three people in the two-drug arm and none in …<\/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":[101],"class_list":["post-2966","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-icaac-46th-2006"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/2966","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=2966"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/2966\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=2966"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=2966"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=2966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}