{"id":14454,"date":"2011-02-01T11:39:23","date_gmt":"2011-02-01T11:39:23","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=14454"},"modified":"2011-02-01T11:39:23","modified_gmt":"2011-02-01T11:39:23","slug":"lopinavirritonavir-women-versus-men","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/14454","title":{"rendered":"Lopinavir\/ritonavir: women versus men"},"content":{"rendered":"

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

Lopinavir\/ritonavir (LPV\/r) is used frequently in pregnancy and in second line regimens in resource limited settings.<\/p>\n

An FDA meta-analysis showed that women made up only 21% of overall participants in phase 2-4 HIV studies from 2000-2006. LPV\/r (Kaletra) was approved in 2005.<\/p>\n

The originator manufacturer, Abbott, performed a meta-analysis from company data to provide some information on the efficacy, safety and tolerability of LPV\/r in women compared to men.<\/p>\n

Ashwaq Hermes presented findings from this analysis of seven randomised controlled trials that met the following inclusion criteria: prospective adult trials using the standard dose as part of a three drug regimen with available data to 48 weeks on viral load, CD4, adverse events and discontinuation rates.<\/p>\n

The investigation included 2022 trial participants. Of these, 492 were women (286 treatment naive and 206 experienced) and 1530 were men (1137 naive and 393 experienced).<\/p>\n

Treatment naive women, treatment naive men and treatment-experienced women were all younger, having mean ages of 39.2, 38.2 and 38.7 years respectively, than treatment-experienced men, who had a mean age of 41.6 years. White participants made up a greater proportion of both groups of men compared to women, 76.4 vs 48.3 and 58.5 vs 37.9, in the treatment naive and experienced groups respectively. More treatment-experienced men had a CD4 count of <50 cells\/mm3 at baseline, 12.6 vs 5.8. All comparisons p<0.05.<\/p>\n

Intent-to-treat analysis revealed similar proportions of women and men with viral load <50 copies\/mL at 48 weeks: 69 vs 74% in treatment naive women and men, p=0.73, and 52 vs 57% in experienced women and men, p=0.3. Mean increases in CD4 count from baseline were also similar between sexes at 48 weeks: 209 vs 200 cells\/mm3 in naive women and men, p=0.42 and 138 vs 123 cells\/mm3 in experienced, p=0.253.<\/p>\n

Incidence of moderate to severe adverse events also did not differ greatly overall between sexes: 34.3 vs 34.9% in treatment naive women and men, p=0.89, and 28.2 vs 25.4% in experienced women and men, p=0.495. Although there was a significant increase in the incidence vomiting, 6.6 vs 2.4%, and dyspepsia, 2.3 vs 0.7%, in naive women compared to men, both p<0.05. Laboratory abnormalities were again similar overall, but with a greater incidence of raised triglycerides (>750 mg\/dL) in 7.2 vs 1.4% in treatment-naive and 7.6 vs 2.0% in treatment-experienced men vs women, respectively (both p<0.05).<\/p>\n

When the investigators looked at overall rates of discontinuation of treatment for any reason, they found that these were greater in treatment-naive women compared to men, 21.7 vs 15.4%, p=0.013. Lost to follow up made up a high proportion of this group, 8.7 vs 4.1%, of women compared to men, p=0.004.<\/p>\n

Among experienced women and men, the overall rates of discontinuation were similar: 23.8 vs 21.9%, p=0.608.<\/p>\n

Discontinuation due to adverse events was greater in treatment naive women compared to men: 8.7 vs 5.2%, p=0.034. However, these rates were similar among the treatment experienced group: 7.8 vs 4.6% of women compared to men, p=0.136.<\/p>\n

Dr Hermes noted that the older gel formulation was used in the treatment naive trials whereas the tablet formulation was used in the trial of treatment-experienced patients.<\/p>\n

The investigators concluded that this analysis revealed no substantial overall differences between women and men with regards to efficacy, safety and tolerability. They are continuing their evaluation of these data.<\/p>\n

comment<\/h2>\n

Overall this meta-analysis of seven randomised controlled studies including 492 women and 1530 men did not find significant differences in virological or immunological response or overall incidence of adverse events.<\/strong><\/p>\n

Although there are always difficulties with interpretation with any post hoc analysis it seems a good idea for companies to look at their own data in this way.<\/strong><\/p>\n

Reference:<\/p>\n

Hermes A et al. Efficacy, safety and tolerability of lopinavir\/ritonavir in HIV-infected women: results of a meta-analysis of 7 prospective, randomised clinical trials through 48 weeks. 1st International Workshop on HIV and Women. 10\u009611 January 2011, Washington. Oral abstract O_17.<\/p>\n","protected":false},"excerpt":{"rendered":"

Polly Clayden, HIV i-Base Lopinavir\/ritonavir (LPV\/r) is used frequently in pregnancy and in second line regimens in resource limited settings. An FDA meta-analysis showed that women made up only 21% of overall participants in phase 2-4 HIV studies from 2000-2006. …<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3,44],"tags":[118],"class_list":["post-14454","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","category-womens-health","tag-intl-workshop-on-hiv-and-women-1st-2011"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/14454","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=14454"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/14454\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=14454"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=14454"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=14454"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}