{"id":5683,"date":"2006-03-25T08:35:50","date_gmt":"2006-03-25T07:35:50","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=5683"},"modified":"2013-12-07T07:49:54","modified_gmt":"2013-12-07T07:49:54","slug":"atazanavir-in-treatment-naive-patients-with-and-without-ritonavir-boosting","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/5683","title":{"rendered":"Atazanavir in treatment naive patients, with and without ritonavir boosting"},"content":{"rendered":"

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

Although there are limited data on using atazanavir (ATZ), with or without ritonavir (RTV), in first line therapy, it is already widely used by some clinicians where once-daily regimens are important but where there is a caution against or intolerance to efavirenz.<\/strong><\/p>\n

Malan and colleagues from Port Elizabeth, South Africa, reported 48-week results from a 96-week study of 199 treatment-naive patients randomised 1:1 to receive either 300mg ATZ\/100mg RTV or 400mg ATZ, in combination with 3TC and d4T-ER (the extended release formulation of d4T that is no longer in development). Mean baseline CD4 count and viral load was 235 cells\/mm3<\/sup> and 4.95 log copies\/mL respectively.<\/p>\n

At 48 weeks, by intent-to-treat analysis, 75% and 70% of the patients in the RTV-boosted and unboosted arms respectively, had viral load reduced to <50 copies\/mL, (difference, 5.0; 95% CI \u00967.0, 17.0). CD4 increases were +189 and +224 cells\/mm3<\/sup> (difference -21.1; 95% CI -48.9, 6.6).<\/p>\n

12% and 10% of patients discontinued before week 48 in the RTV and unboosted arms, and although similar rates of drug-related adverse events of at least moderate intensity were comparable between arms, adverse events-related discontinuations occurred more commonly in the ATV\/r arm (8%) than the ATV arm (1%).<\/p>\n

Persistent hyperbilirubinemia. jaundice and scleral icterus (all grades) were more common in the ritonavir-boosted ATZ\/r arm (22%; 23%) than the ATV arm (7%; 13%).<\/p>\n

At baseline, mean total cholesterol was 161 mg\/dL and mean triglycerides was 145 mg\/dL. Total cholesterol increased by a mean 15% for the ATV\/r arm vs 6% for the ATV arm (p <0.01); mean increase in triglycerides was 26% for ATV\/r vs \u00963% for ATV (p <0.01); a shift of NCEP triglyceride category occurred in 16% for ATV\/r vs 11% for ATV.<\/p>\n

Comment<\/h3>\n

This study is underpowered to answer the question of non-inferiority of unboosted ATV compared to ATV\/r. Boosted ATV\/r looses a substantial part of its potentially beneficial \u0091lipid friendly\u0092 properties. No data on the relevant issue of the development of resistance to ATV was shown.<\/strong><\/p>\n

Atazanavir, boosted by ritonavir, only received approval for second-line indication in Europe. In the US atazanavir, boosted by ritnonavir, is approved for use in treatment naive and treatment experienced patients.<\/strong><\/p>\n

NOTE (added 2007): a paper in JAIDS reported a high rate of virological failure in a Swedish study of atazanavir\/r monotherapy that resulted in early termination of the study.<\/strong> [2]<\/p>\n

References:<\/p>\n

    \n
  1. Malan N, Krantz E, David N et al. Efficacy and safety of atazanavir-based therapy in antiretroviral naive HIV-1 infected subjects, both with and without ritonavir: 48-week results from AI424-089. 13th Conference on Retroviruses and Opportunistic Infections, 5-8 February 2006, Denver, Colorado. Abstract 107LB.<\/li>\n
  2. Karlstr\u00f6m\u00a0et al.\u00a0Early virologic rebound in a pilot trial of ritonavir-boosted atazanavir as maintenance monotherapy. J Acquir Immune Defic Syndr. 2007 Apr 1;44(4):417-22.<\/li>\n<\/ol>\n

    http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/17159658<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base Although there are limited data on using atazanavir (ATZ), with or without ritonavir (RTV), in first line therapy, it is already widely used by some clinicians where once-daily regimens are important but where there is a …<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[60],"class_list":["post-5683","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-croi-2006"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/5683","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=5683"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/5683\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=5683"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=5683"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=5683"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}