{"id":37164,"date":"2020-02-24T08:39:17","date_gmt":"2020-02-24T08:39:17","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=37164"},"modified":"2020-02-24T15:31:20","modified_gmt":"2020-02-24T15:31:20","slug":"bictegravir-emtricitabine-tenofovir-alafenamide-appears-to-be-safe-and-effective-in-women-results-from-a-pooled-analysis","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/37164","title":{"rendered":"Bictegravir\/emtricitabine\/tenofovir alafenamide appears to be safe and effective in women: results from a pooled analysis"},"content":{"rendered":"

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

A pooled analysis of women and girls receiving bictegravir\/emtricitabine\/tenofovir alafenamide (B\/F\/TAF) in five clinical trials showed high rates of virological suppression at 48 weeks, according to data presented at EACS 2019.<\/strong><\/p>\n

Rates of adverse events (AEs) were similar to those seen among participants receiving comparator regimens.<\/p>\n

There were not sufficient numbers of B\/F\/TAF-exposed pregnancies to draw any conclusions.<\/p>\n

Co-formulated B\/F\/TAF 50\/200\/25 mg is a once-daily fixed dose combination manufactured by Gilead Sciences.<\/p>\n

This analysis included 679 women and girls receiving B\/F\/TAF or comparators (373 B\/F\/TAF) across five phase 2\/3 originator clinical trials, conducted in ART naive adults and virologically suppressed children, adolescents and adults through 48 weeks. See Table 1.<\/p>\n

Table 1: Pooled analysis of women in phase 2\/3 bictegravir\/emtricitabine\/tenofovir alafenamide studies\u00a0 \u00a0<\/strong><\/p>\n\n\n\n\n\n\n\n
Study<\/td>\nPopulation<\/td>\nComparator regimen(s)<\/td>\nWomen B\/F\/TAF arm (n)<\/td>\nWomen comparator arm (n)<\/td>\n<\/tr>\n
1489\/1490<\/td>\nART naive adults<\/td>\nDTG\/ABC\/3TC (1489) DTG+F\/TAF (1490)<\/td>\n69<\/td>\n70<\/td>\n<\/tr>\n
1961<\/td>\nSuppressed women<\/td>\nE\/C\/F\/TAF E\/C\/F\/TDF ATV\/r\/F\/TAF<\/td>\n234<\/td>\n236<\/td>\n<\/tr>\n
1464<\/td>\nSuppressed (2 NRTIs + 3rd agent) children and adolescents\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 6\u2013 17 years<\/td>\n<\/td>\n59<\/td>\n<\/td>\n<\/tr>\n
4449<\/td>\nSuppressed (2 NRTIs + 3rd agent) adults 65+<\/td>\n<\/td>\n11<\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Key: ABC, abacavir; ATV\/r, atazanavir\/ritonavir; B, bictegravir; DTG, dolutegravir; E, elvitegravir; F, emtricitabine; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate; 3TC lamivudine<\/p>\n

The comparator arm in study 1489 was dolutegravir\/abacavir\/lamivudine (DTG\/ABC\/3TC) and in 1490 DTG\/F\/TAF. Notably the total number of participants in these naive studies was 1274 of which only 139 were women.<\/p>\n

Women in study 1961 were previously enrolled in the women-only WAVES study (elvitegravir\/cobicistat\/emtricitabine\/tenofovir E\/C\/F\/TDF or E\/C\/F\/TAF vs atazanavir\/r-based ART) and its open label extension in which they all received elvitegravir-based ART.<\/p>\n

Paediatric switch study 1464 had 100 participants in total, of which 59 were young women and girls. And switch study 4449, in participants aged 65+, had 86 in total of which 11 were women.<\/p>\n

In the pooled analysis, demographics among women and girls by age and baseline treatment group were as follows. Virologically suppressed: 6\u201317 years (n=59); 18\u201349 years (n=191); 50\u201364 years (n=43) and 65\u201375 (n=11). ART naive: 18\u201349 years (n=54) and 50\u201368 (n=15).<\/p>\n

There was considerable variation in ethnicity, particularly among virologically suppressed participants: from 78% black among 6\u201317 year-olds to 91% white in the 65\u201375 years age group. In the ART-naive group just under half of the participants were black and 35\u201340% were white.<\/p>\n

At week 48 there were high and similar rates of virologic suppression across age and treatment groups (B\/F\/TAF 87\u2013100% and comparators 88\u201395%). These findings are consistent with those seen overall in the B\/F\/TAF studies across both sexes. \u00a0No treatment-emergent resistance was seen with B\/F\/TAF across the programme.<\/p>\n

Drug-related AEs were similar among participants taking B\/F\/TAF versus comparators. Overall rates of grade 3\/4 AEs were low and similar to comparators. One adolescent (0.1%) discontinued B\/F\/TAF due to anxiety.<\/p>\n

Weight gain was reported as an AE in 3\/314 women receiving B\/F\/TAF (all in ART-naive group aged 18\u201349); weight loss was reported in 1\/314. There was 1\/306 weight gain and 1\/306 weight loss among the participants receiving comparator ART.<\/p>\n

At week 48 the median change from baseline weight in the virologically suppressed participants receiving B\/F\/TAF was 1.5 kg vs 0.4 kg in the comparators (p<0.001). Among these participants 53% received TAF and the remainder TDF.<\/p>\n

The difference in median change between B\/F\/TAF and comparators in the ART-naive participants was non-significant at weeks 48 and 144. The respective weight gain from baseline at week 144 was 5 kg, 7.9 kg and 4.9 kg in the B\/F\/TAF (n=50), DTG\/ABC\/3TC (n=29) and DTG + F\/TAF (n=29) groups. But numbers were very small.<\/p>\n

The presentation also included weight gain in men. Of note in the ART-naive group differences in weight gain from baseline for men receiving B\/F\/TAF vs DTG\/ABC\/3TC were significant: 3 kg vs 1.4 kg (p<0.0001) and 4.2 kg vs 3.2 kg (p=0.03) at 48 and 144 weeks respectively. There were no significant differences in weight gain among men receiving B\/F\/TAF and DTG+F\/TAF. There were over 1000 men in the ART naive group.<\/p>\n

Cumulative to 17 October 2019, there were 30 B\/F\/TAF exposed pregnancies across the Gilead trials: 25 prospective, 4 retrospective and one unknown reports.<\/p>\n

Among the prospective reports 21 exposures were preconception\/first trimester, 2 were second\/third trimester and 2 unknown. The 4 retrospective reports were all preconception\/first trimester as was the unknown prospective or retrospective pregnancy.<\/p>\n

Of these there were 15 live births with no congenital anomaly; 1 live birth with patent urachus; 3 with unknown outcome; 7 spontaneous abortion; 1 still birth and 3 elective terminations.<\/p>\n

There were no cases of CNS congenital anomalies or neural tube defects but no prevalence can be calculated as retrospective reports are drawn from a population in which the number of exposed pregnancies is unknown.<\/p>\n

Presenting author Chloe Orkin made a plea to the audience to report pregnancies retrospectively and reminded us that in the US only 10% are reported.<\/p>\n

Reference<\/p>\n

Orkin C et al. Efficacy and safety of bictegravir\/emtricitabine\/tenofovir alafenamide vs comparators in cis-women and girls (living with HIV): an analysis of 5 clinical trials. 17th European AIDS Conference (EACS). Basel, Switzerland. 6\u20139 November, 2019. Oral abstract PS7\/6.
\nhttp:\/\/europeanaidsconference.eacs.cyim.com\/mediatheque\/media.aspx?mediaId=78084&channel=28172 <\/a>(webcast)<\/p>\n","protected":false},"excerpt":{"rendered":"

Polly Clayden, HIV i-Base A pooled analysis of women and girls receiving bictegravir\/emtricitabine\/tenofovir alafenamide (B\/F\/TAF) in five clinical trials showed high rates of virological suppression at 48 weeks, according to data presented at EACS 2019. Rates of adverse events (AEs) …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,35],"tags":[],"class_list":["post-37164","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-pmtct-and-maternal-health"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/37164","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=37164"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/37164\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=37164"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=37164"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=37164"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}