{"id":32693,"date":"2017-10-01T11:48:34","date_gmt":"2017-10-01T11:48:34","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=32693"},"modified":"2017-10-05T14:27:37","modified_gmt":"2017-10-05T14:27:37","slug":"once-daily-raltegravir-96-weeks-results-from-the-oncemrk-study","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/32693","title":{"rendered":"Once-daily raltegravir: 96-week results from the ONCEMRK study"},"content":{"rendered":"

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

Longer follow-up results from the phase 3 registrational ONCEMRK study were presented at IAS 2017 as a later breaking poster. [1]<\/strong><\/p>\n

This was a double-blind, placebo-controlled non-inferiority study in 797 treatment naive participants randomised (2:1) to either the once-daily formulation (2 x 600 mg once-daily) or the original version (400 mg twice-daily). TDF\/FTC were used as background NRTIs in both groups.<\/p>\n

Baseline characteristics and demographics have been described before but this was a largely was male (85%), white (60%) study with mean (SD) age 36 (+\/\u201310.5) years. Mean CD4 and viral load were 415 cells\/mm3<\/sup> and 4.6 log copies\/mL respectively, with 28% having viral load >100,000 copies\/mL.<\/p>\n

At 96 weeks, viral load was <40 copies\/mL in 81% vs 80% of participants (difference: +1.4; 95%CI: \u2013\u00ad4.4 to +7.3), continuing to show non-inferiority. This compared to the primary endpoint virological response rates of 88% in each arm at week 48 (difference: +0\u00b75%; 95% CI: \u22124\u00b72 to 5\u00b72).<\/p>\n

Response rates at 96 weeks for those with baseline viral load >100,000 copies\/mL, were 85% vs 83% (difference: +1.8; 95%CI: \u20138.2 to +13.6).<\/p>\n

Although discontinuation rates were similar in each group (n=64 vs 39) most were due to participant withdrawal or lost to follow-up. Viral non-response was reported in 6 vs 3 participants and discontinuation due to side effects in 7 vs 6 participants.<\/p>\n

Resistance to raltegravir was infrequent, occurring in 4\/531 (0.8%) and 2\/266 (0.8%) in the QD and BID groups, respectively. CD4 responses at week 96 were similar (approximately +260 cells\/mm3<\/sup> in each arm) as were tolerability and side-effects.<\/p>\n

comment<\/h3>\n

Based on 48-week results from ONCEMRK, the once-daily formulation of raltegravir was approved in May 2017. [2]<\/strong><\/p>\n

Raltegravir 600 mg was launched in the UK on 26 September 2017. [3]<\/strong><\/p>\n

The 48-week results from ONCEMRK were also recently published online. [4]<\/strong><\/p>\n

Reference<\/p>\n

    \n
  1. Cahn P et al. Raltegravir (RAL) 1200 mg once daily (QD) versus RAL 400 mg twice daily (BID), in combination with tenofovir disoproxil fumarate\/emtricitabine (TDF\/FTC), in previously untreated HIV-1 infection through week 96. IAS 2017. TULBPEB20.
    \nhttp:\/\/programme.ias2017.org\/Abstract\/Abstract\/5493<\/a> (abstract)
    \n    http:\/\/programme.ias2017.org\/\/PAGMaterial\/eposters\/5493.pdf<\/a> (poster PDF)<\/li>\n
  2. Merck press statement. Merck receives FDA approval of Isentress HD (raltegravir), a new once-daily option, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in appropriate patients. (30 May 2017).
    \n    http:\/\/investors.merck.com\/news\/press-release-details\/2017\/Merck-Receives-FDA-Approval-of-ISENTRESS-HD-raltegravir-a-New-Once-Daily-Option-in-Combination-with-Other-Antiretroviral-Agents-for-the-Treatment-of-HIV-1-Infection-in-Appropriate-Patients\/default.aspx<\/a><\/li>\n
  3. MSD press release. MSD\u2019s Isentress (raltegravir) 600 mg launched in the UK. (26 September 2017).
    \n    http:\/\/www.pharmatimes.com\/news\/msd_launches_once-daily_isentress_in_the_uk_1206406<\/a><\/li>\n
  4. Cahn P et al. Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial. Lancet HIV. Published online 11 September 2017. DOI: 10.1016\/S2352-3018(17)30128-5.
    \n    http:\/\/www.thelancet.com\/journals\/lanhiv\/article\/PIIS2352-3018(17)30128-5\/fulltext<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base Longer follow-up results from the phase 3 registrational ONCEMRK study were presented at IAS 2017 as a later breaking poster. [1] This was a double-blind, placebo-controlled non-inferiority study in 797 treatment naive participants randomised (2:1) to …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[243],"class_list":["post-32693","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-ias-9-paris-2017"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/32693","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=32693"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/32693\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=32693"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=32693"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=32693"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}