{"id":7879,"date":"2010-02-21T13:03:25","date_gmt":"2010-02-21T13:03:25","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=7879"},"modified":"2013-08-06T06:35:46","modified_gmt":"2013-08-06T06:35:46","slug":"once-daily-darunavirr-monotherapy-is-suboptimal-as-initial-regimen-in-treatment-naive-people","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/7879","title":{"rendered":"Once-daily darunavir\/r monotherapy is suboptimal as initial regimen in treatment-naive people"},"content":{"rendered":"

Simon Collins, HIV\u00a0i-Base<\/strong><\/p>\n

A tiny pilot for a Phase 2 study in treatment naive patients was stopped prematurely, concluding that once-daily darunavir\/r was not sufficiently potent<\/strong>
\n as initial treatment in treatment naive patients for the study to continue.<\/strong><\/p>\n

Seven patients (with baseline viral load <100,000 copies\/mL and CD4 counts >100 cells\/mm3 and no evidence of drug resistance) were started on
\nopen-label darunavir\/r monotherapy. At week 4, all patients had >1 log drop in viral load and by week 8, viral load was <400 copies\/mL in 4\/7.
\nHowever, the trial was stopped as 5\/7 patients had inadequate viral responses (together with the high level of screening failures – 38\/45 screened – which
\nwould limit enrollment for the larger planned study).<\/p>\n

All seven patients achieved viral loads <50 copies\/mL following intensification with nucleosides. CD4 responses at week 12 were +167 cells\/mm3. No
\ngrade 3-4 clinical or laboratory events were reported. No darunavir-associated mutations were seen in the two patients with genotype results.<\/p>\n

COMMENT <\/strong><\/p>\n

Although these results were disappointing as initial therapy, an analysis of the MONET study that randomised people with undetectable viral load
\n(<50 copies\/mL) on any HAART regimen to either darunavir\/r as monotherapy or plus dual RTIs, reported non-inferiority (difference = \u00961.6; 95%CI \u009610.1 to
\n+6.8%) in terms of the percentage of people in each group with <50 copies\/mL at week 48 (86.2% vs 87.8% respectively). [2] <\/strong><\/p>\n

These results were supported by other analyses, which is important for the continued use of darunavir\/r in the currently enrolling MRC PIVOT study
\nof PI-monotherapy maintenance therapy. [3]<\/strong><\/p>\n

References:<\/p>\n

    \n
  1. Patterson P et al. A Phase II, open-label trial in treatment-naive. HIV-1-infected subjects who received DRV\/RTV as induction monotherapy. 12th\u00a0EACS, 11-14 November 2009, Cologne. Abstract PS4\/4.<\/li>\n
  2. Ripamonti D et al. Non-inferior efficacy shown across different efficacy endpoints in the MONET trial of darunavr\/ritonaivr (DRV\/r) monotherapy.\u00a012th EACS, 11-14 November 2009, Cologne. Abstract PS 4\/1.<\/li>\n
  3. PIVOT: Protease Inhibitor monotherapy Versus Ongoing Triple-therapy in the long-term management of HIV infection.
    \nhttp:\/\/www.ctu.mrc.ac.uk\/research_areas\/study_details.aspx?s=55<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV\u00a0i-Base A tiny pilot for a Phase 2 study in treatment naive patients was stopped prematurely, concluding that once-daily darunavir\/r was not sufficiently potent as initial treatment in treatment naive patients for the study to continue. Seven patients …<\/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":[72],"class_list":["post-7879","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-eacs-12th-2009"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/7879","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=7879"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/7879\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=7879"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=7879"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=7879"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}