{"id":37149,"date":"2020-02-24T08:43:35","date_gmt":"2020-02-24T08:43:35","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=37149"},"modified":"2020-02-25T09:23:01","modified_gmt":"2020-02-25T09:23:01","slug":"long-acting-cabotegravir-and-rilpivirine-similar-results-in-women-and-men","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/37149","title":{"rendered":"Long-acting cabotegravir and rilpivirine: similar results in women and men\u00a0"},"content":{"rendered":"

\"\"Polly Clayden, HIV i-Base<\/span><\/strong><\/p>\n

A pooled analysis of two phase 3 trials of monthly long acting cabotegravir and rilpivirine (CAB + RPV LA) found similar efficacy among women and men at 48 weeks. [1]<\/span><\/b><\/span><\/p>\n

There were also <\/span><\/span>no significant differences between women and men in adverse events (AEs), injection site pain or study withdrawals. And treatment satisfaction was higher among women in the CAB + RPV LA arm vs control.\u00a0\u00a0 <\/span><\/p>\n

Romina Quercia from ViiV Healthcare presented these results at EACS 2019 from an analysis of efficacy, safety and patient satisfaction among women participants in the ATLAS and FLAIR trials.<\/span><\/span><\/p>\n

ATLAS and FLAIR are randomised (1:1), international, open label studies that demonstrated non-inferiority of switching to monthly intramuscular (IM) injections of CAB + RPV LA vs current antiretroviral regimen.<\/span><\/span><\/p>\n

ATLAS enrolled ART-experienced participants on stable ART (two NRTIs and a third agent). FLAIR participants were ART-naive and the study included a 20-week induction phase with dolutegravir\/abacavir\/lamivudine oral fixed dose combination.<\/span><\/span><\/p>\n

At randomisation, participants in the CAB + RPV LA arms in both studies received oral CAB + RPV for four weeks before receiving IM injections.<\/span><\/span><\/p>\n

Both studies were designed with enrolment targets for women: ATLAS at least one in four and FLAIR one in five participants.<\/span><\/span><\/p>\n

Pooled subgroup analysis by sex at birth was pre-planned and based on week 48 primary endpoint of viral load ><\/u>50 copies\/mL and secondary endpoint of <50 copies\/mL. <\/span><\/span><\/p>\n

Across the two trials there were 27% (162\/591) women in the CAB + RPV LA arms and 28% (168\/591) in the control arms.<\/span><\/span><\/p>\n

At baseline, 28% of women had BMI ><\/u>30 kg\/m2<\/sup> compared with 13% of men. Almost 40% of women were black or African American compared with just below 15% of men.<\/span><\/span><\/p>\n

At week 48, 3.1% and 0.6% of women in CAB + RPV LA and control arms had viral load\u00a0><\/u>50 copies\/mL. These proportions were similar for men, respectively 1.4% and 2.1%. Suppression rates were also similar between women and men.<\/span><\/span><\/p>\n

Seven confirmed virological failures occurred in both arms including 5\/7 and 2\/7 women in the CAB\/RPV LA and control arms respectively. These cases are under analysis and currently considered to be multifactorial.\u00a0\u00a0\u00a0 <\/span><\/span><\/p>\n

There were no significant differences between women and men in AEs and injection site reactions (most grade 1 or 2 and none severe). Women reported less injection site pain than men: 66% vs 82%.\u00a0 Two women and four men withdrew from the studies due to injection site reactions (both approximately 1%).<\/span><\/span><\/p>\n

Retention in the studies was high for women receiving CAB + RPV LA: 90% (overall 92%).<\/span><\/span><\/p>\n

In a post-hoc analysis at week 44, CAB + RPV participants showed higher treatment satisfaction vs those in the control arm. This increased from baseline and was greater among women participants.<\/span><\/span><\/p>\n

comment<\/span><\/p>\n

The enrollment of\u00a0<\/span><\/b><\/span>almost 30%\u00a0<\/b>in these trials is laudable and considerably more than what we have come to expect in industry phase 3 trials of antiretrovirals.<\/b><\/span><\/span><\/p>\n

One notable sex difference reported for CAB is longer half-life for women and men. CAB is still detectable after 3.5 years following a single injection in some women vs 2.5 years in some men.<\/b><\/p>\n

In a related presentation in this session, we were reminded that about 38 million people are living with HIV of which just over 19 million are women. This proportion of 50.4% is in stark contrast to the 18.9% of women study participants in HIV clinical trials shown in a recent analysis. [2] <\/span><\/b><\/span><\/p>\n

The investigations in the pooled analysis of CAB + RPV LA did not reveal any significant sex differences at 48 weeks. But having a larger group of women meant that this information was not based on a meaningless subgroup analysis among only a handful of participants.<\/span><\/b><\/span><\/p>\n

Having enrolment targets for women was also associated with a more diverse population than often seen in phase 3 studies. In the pooled analysis, almost 40% of women were black or African American (compared with less than 15% of men). Less than half of the women were recruited from Western Europe or North America (compared with 75% of men) and 21% were from South Africa compared with 4% of men. <\/span><\/b><\/span><\/b><\/p>\n

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

1.\u00a0\u00a0\u00a0\u00a0\u00a0 Quercia R et al.\u00a0Outcomes for women in phase 3 trials of long-acting cabotegravir + rilpivirine: pooled ATLAS and FLAIR week 48 results.<\/b><\/span>17th European AIDS Conference (EACS). Basel, Switzerland. 6\u20139 November, 2019. Oral abstract PS1\/1.\u00a0 <\/span><\/p>\n

\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0http:\/\/resourcelibrary.eacs.cyim.com\/?mediaId=78023<\/a>(webcast)<\/span><\/p>\n

2.\u00a0\u00a0\u00a0Sander F et al. <\/span>Are there gender and age differences in ARV PK? 17th European AIDS Conference (EACS). Basel, Switzerland. 6\u20139 November, 2019. Oral presentation ML1.<\/p>\n

\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 http:\/\/resourcelibrary.eacs.cyim.com\/?mediaId=78017<\/a><\/span>(webcast)<\/p>\n","protected":false},"excerpt":{"rendered":"

Polly Clayden, HIV i-Base A pooled analysis of two phase 3 trials of monthly long acting cabotegravir and rilpivirine (CAB + RPV LA) found similar efficacy among women and men at 48 weeks. [1] There were also no significant differences …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3,44],"tags":[276],"class_list":["post-37149","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","category-womens-health","tag-eacs-17-basel-2019"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/37149","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=37149"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/37149\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=37149"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=37149"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=37149"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}