{"id":33575,"date":"2018-03-14T11:35:19","date_gmt":"2018-03-14T11:35:19","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=33575"},"modified":"2018-03-15T12:15:19","modified_gmt":"2018-03-15T12:15:19","slug":"dual-therapy-can-reduce-tb-prophylaxis-from-nine-months-to-one-similar-efficacy-with-fewer-side-effects-and-greater-completion-rate","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/33575","title":{"rendered":"Dual therapy can reduce TB prophylaxis from nine months to one: fewer side effects and more people complete treatment"},"content":{"rendered":"

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

New results from a large international study using a simplified approach to prevent TB have the potential to dramatically improve outcomes for HIV positive people, cutting prophylaxis from nine months to one.<\/strong><\/p>\n

The BRIEF-TB study randomised 3000 adults with either latent TB or at high risk of TB infection to either one month of daily isoniazid (H) 300 mg plus rifapentine (P) 450 – 600 mg or to the standard of care nine-month regimen with daily isoniazid 300 mg.<\/p>\n

The study included three years follow-up with primary endpoints of incidence rates (IR) of active TB, TB death or death by unknown cause, and stratified participants by ART use.<\/p>\n

\"\"

Richard Chaisson at the CROI 2018 press conference<\/p><\/div>\n

This was a non-inferiority study with lower margin of 1.25\/100 patient years, based on an assumed IR of 2.0\/100 PY in the nine-month arm.\u00a0Results were presented by Richard Chaisson from Johns Hopkins University.<\/p>\n

The study recruited participants from May 2012 to November 2011 in 45 sites in 10 countries.<\/p>\n

Baseline demographics included 54% women (n=1614), median age 35 years (IQR 28-43), with 66% black and 24% Hispanic. Median CD4 count was 470 cells\/mm3<\/sup> (IQR 346 to 635) and 50% were on ART at entry. Median BMI was 23.5 (IQR 20.9 to 27.1). Approximately 20% (n=634) had latent TB defined by positive TST or IGRA.<\/p>\n

After three years of follow-up, there was no significant difference in the rate of primary events: in 34 vs 35 participants in the one vs nine month arms respectively. TB incidence rates were 0.69 vs 0.72\/100 person years respectively (difference \u20130.025, upper 95% CI: 0.31).<\/p>\n

Rates were higher for participants not on ART at entry and those with a positive TST\/IGRA, but with no difference between treatment arms. Higher incidence in the one-month arm with baseline CD4 count <250 cells\/mm3<\/sup> was not statistically significant (p=0.12). See Table 1.<\/p>\n

Although higher serious adverse events in the nine-month arm (7.1% vs 5.6%) were not statistically significant (p=0.1), targeted safety events was significantly lower with one month of treatment (3.3 vs 5.1\/100 person years , p=0.03). Importantly the one-month course was more likely to be completed (97% vs. 90%, p<0.01).<\/p>\n

There was one case of rifampin-resistant TB in each arm and one case of izoniazid-resistant TB in the nine-month arm.<\/p>\n

The researchers concluded that once daily izoniazid plus rifampentine was non-inferior to nine-months izoniazid, with fewer side events, and higher completion rates.<\/p>\n

Table 1: Incidence of primary events by baseline characteristics<\/strong><\/p>\n\n\n\n\n\n\n\n\n
Characteristics<\/strong><\/td>\nOne-month (H+P)<\/strong>\n

Event \/ PY<\/p>\n

(IR\/100PY)<\/p><\/td>\n

Nine-month (H)<\/strong>\n

Event \/ PY<\/p>\n

(Rate\/100PY)<\/p><\/td>\n

IR difference: 1\u20139 month<\/strong>\n

(95%CI)<\/p>\n

All p=NS between groups<\/em><\/p><\/td>\n<\/tr>\n

All participants<\/strong><\/td>\n32\/4926\n

(0.65)<\/p><\/td>\n

33\/4896\n

(0.67)<\/p><\/td>\n

\u20130.023\n

(\u20130.30 to +0.35)<\/p><\/td>\n<\/tr>\n

Baseline ART<\/strong>\n

Yes<\/p>\n\n

No<\/p><\/td>\n

 \n

14\/2378<\/p>\n

(0.59)<\/p>\n

20\/2545<\/p>\n

(0.79)<\/p><\/td>\n

 \n

14\/2397<\/p>\n

(0.58)<\/p>\n

21\/2487<\/p>\n

(0.84)<\/p><\/td>\n

 \n\n

0.005 (\u20130.43 to +0.44)<\/p>\n

\u20130.059 (\u20130.55 to +0.44)<\/p><\/td>\n<\/tr>\n

TST\/IGRA status<\/strong>\n

Positive<\/p>\n\n

Negative<\/p><\/td>\n

 \n

11\/1107<\/p>\n

(0.99)<\/p>\n

23\/3816<\/p>\n

(0.60<\/p><\/td>\n

 \n

12\/1133<\/p>\n

(1.06)<\/p>\n

23\/3751<\/p>\n

(0.61)<\/p><\/td>\n

 \n\n

\u20130.066 (\u20130.90 to +0.77)<\/p>\n

\u20130.01 (\u20130.36 to +0.34)<\/p><\/td>\n<\/tr>\n

Baseline CD4 (copies\/mm3<\/sup>)<\/strong>\n

<250<\/p>\n\n

>250<\/p><\/td>\n

 \n

14\/619<\/p>\n

(2.26)<\/p>\n

20\/4304<\/p>\n

(0.46)<\/p><\/td>\n

 \n

7\/627<\/p>\n

(1.12)<\/p>\n

28\/4256<\/p>\n

(0.66)<\/p><\/td>\n

 \n\n

1.15 (\u20130.30 to +2.59)<\/p>\n\n

\u20130.19 (\u20130.51 to +0.12)<\/p><\/td>\n<\/tr>\n

Sex<\/strong>\n

Men<\/p>\n\n

Women<\/p><\/td>\n

 \n

12\/2300<\/p>\n

(0.52)<\/p>\n

22\/2622<\/p>\n

(0.84)<\/p><\/td>\n

 \n

17\/2285<\/p>\n

(0.74)<\/p>\n

18\/2599<\/p>\n

(0.69)<\/p><\/td>\n

 \n\n

\u20130.22 (\u20130.68 to +0.24<\/p>\n\n

0.15 (\u20130.33 to +0.62)<\/p><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

comment<\/h3>\n

The effectiveness of current TB prophylaxis for people with HIV is limited by the difficulties of taking nine months of isoniazid \u2013 despite their dramatically higher need for this protection.<\/strong><\/p>\n

These results are likely to change management of HIV in people with latent TB or in high TB incidence settings.<\/strong><\/p>\n

Reference<\/p>\n

Swindells S et al. One month of rifapentine\/isoniazid to prevent TB in people with HIV: BRIEF-TB\/A5279. CROI, 4-7 March 2018. Late breaker oral abstract 37LB.
\nhttp:\/\/www.croiconference.org\/sessions\/one-month-rifapentineisoniazid-prevent-tb-people-hiv-brief-tba5279<\/a> (abstract)
\nhttp:\/\/www.croiwebcasts.org\/console\/player\/37077<\/a> (webcast)<\/p>\n\n","protected":false},"excerpt":{"rendered":"

Simon Collins, HIV i-Base New results from a large international study using a simplified approach to prevent TB have the potential to dramatically improve outcomes for HIV positive people, cutting prophylaxis from nine months to one. The BRIEF-TB study randomised …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,37],"tags":[251],"class_list":["post-33575","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-tb-coinfection","tag-croi-2018"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/33575","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=33575"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/33575\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=33575"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=33575"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=33575"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}