{"id":43121,"date":"2022-07-01T07:46:48","date_gmt":"2022-07-01T07:46:48","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=43121"},"modified":"2022-09-12T07:21:39","modified_gmt":"2022-09-12T07:21:39","slug":"namsal-study-comparing-dtg-to-efv400-in-cameroon-week-192-results","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/43121","title":{"rendered":"CROI 2022: NAMSAL study comparing DTG to EFV400 in Cameroon: week 192 results"},"content":{"rendered":"
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Polly Clayden, HIV i-Base<\/b><\/p>\n<\/div>\n

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\"CROIFour-year follow-up of ART-naive adults living with HIV in Cameroon, who were randomised to either dolutegravir (DTG)-based or low-dose efavirenz (EFV400)-based treatment, suggests durability of both regimens long-term. <\/span><\/b><\/p>\n<\/div>\n

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These findings from the NAMSAL study were presented at CROI 2022.<\/span><\/b><\/p>\n<\/div>\n

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Drug resistance was reported at low rates in the EFV arm and in none of the DTG participants. Weight gain continued to be notable among women receiving DTG. <\/span><\/p>\n<\/div>\n

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NAMSAL was an open-label, multicenter, randomised, phase 3 non inferiority trial, conducted over 96 weeks. This was extended as a prospective cohort until week 192. <\/span><\/p>\n<\/div>\n

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Adults with viral load >1000 copies\/mL were randomised (1:1) to receive DTG or EFV 400 \u2013 both combined with tenofovir-disoproxil-fumarate (TDF)\/lamivudine (3TC). <\/span><\/p>\n<\/div>\n

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The primary end point was the proportion of participants with viral load of <50 copies\/mL at week 48. <\/span><\/p>\n<\/div>\n

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Week 48 and 96 data showed DTG to be non-inferior to EFV. [2, 3] But DTG was associated with substantial and continuing weight gain, particularly among women. <\/span><\/p>\n<\/div>\n

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At week 192, a slightly higher proportion of participants (ITT population) in the DTG arm, achieved viral load <50 copies\/mL vs the EFV arm 214\/310 (69%) vs 187\/303 (62%): difference 7.3% (CI 95% 0.20 to 15.45), p=0.057. <\/span><\/p>\n<\/div>\n

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In the fourth-year of follow-up there were five (2 in DTG and 3 in EFV 400 arms) new virological failures without related resistance mutations (NNRTI+\/-NRTI). <\/span><\/p>\n<\/div>\n

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At week 192, the mean weight gain was greater in women compared to men: women, DTG +8.0 kg and EFV 400 +5.0 kg (p=0.010); men, DTG +6.0 kg, EFV400 +4.0 kg (p=0.024). Incidence of obesity in the respective arms was: women, 17% and 11% (p=0.140) and men 26% and 3% (p<0.001).<\/p>\n<\/div>\n

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The investigators noted that close cardiovascular and metabolic monitoring should be recommended to take into account risks related to weight-gain. <\/span><\/p>\n<\/div>\n

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References<\/span><\/p>\n<\/div>\n

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    \n
  1. Mpoudi Ngole-Etame M et al. Long-term outcomes of dolutegravir and efavirenz-400 as first-line ART in Cameroon. CROI 2022.12\u201316 February. Virtual. Poster abstract 493.
    \n<\/span>https:\/\/www.croiconference.org\/abstract\/long-term-outcomes-of-dolutegravir-and-efavirenz-400-as-first-line-art-in-cameroon\/<\/a> (abstract and\u00a0poster)<\/li>\n
  2. Clayden P. Dolutegravir non-inferior to low dose efavirenz in real-life African study conducted in Cameroon. HTB. 13 November 2018.
    \n    https:\/\/i-base.info\/htb\/35235<\/a><\/li>\n
  3. Clayden P. Dolutegravir non-inferior to efavirenz at week 96 in the NAMSAL study but associated with substantial weight gain. HTB. 28 August 2020.
    \n    https:\/\/i-base.info\/htb\/38778<\/a><\/li>\n<\/ol>\n

    This report was first published on 10 June 2022.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Polly Clayden, HIV i-Base Four-year follow-up of ART-naive adults living with HIV in Cameroon, who were randomised to either dolutegravir (DTG)-based or low-dose efavirenz (EFV400)-based treatment, suggests durability of both regimens long-term. These findings from the NAMSAL study were presented …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,41],"tags":[318],"class_list":["post-43121","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-treatment-strategies","tag-croi-2022"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/43121","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=43121"}],"version-history":[{"count":1,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/43121\/revisions"}],"predecessor-version":[{"id":44026,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/43121\/revisions\/44026"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=43121"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=43121"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=43121"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}