Advertisement

TheBodyPRO Covers CROI 2018

News

Dual Therapy Can Reduce TB Prophylaxis From Nine Months to One: Fewer Side Effects and More People Complete Treatment

March 7, 2018

Richard Chaisson at the CROI 2018 press conference

Richard Chaisson at the CROI 2018 press conference (Courtesy of 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 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.

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.

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. Results were presented by Richard Chaisson from Johns Hopkins University.

The study recruited participants from May 2012 to November 2011 in 45 sites in 10 countries.

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 (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.


Related: Once-Daily Tenofovir Alafenamide Appears Sufficient When Dosed With Rifampicin

Advertisement


After three years of follow-up, there were 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 -0.025, upper 95% CI: 0.31).

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 was not statistically significant (p=0.12). See Table 1.

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 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).

There was one case of rifampin-resistant TB in each arm and one case of izoniazid-resistant TB in the nine-month arm.

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


Table 1: Incidence of Primary Events by Baseline Characteristics
Characteristics One-month (H+P)

Event / PY

(IR/100PY)

Nine-month (H)

Event / PY

(Rate/100PY)

IR difference: 1-9 month

(95%CI)

All p=NS between groups

All participants 32/4926

(0.65)

33/4896

(0.67)

-0.023

(-0.30 to +0.35)

Baseline ART

Yes

No

14/2378

(0.59)

20/2545

(0.79)

14/2397

(0.58)

21/2487

(0.84)

0.005 (-0.43 to +0.44)

-0.059 (-0.55 to +0.44)

TST/IGRA status

Positive

Negative

11/1107

(0.99)

23/3816

(0.60

12/1133

(1.06)

23/3751

(0.61)

-0.066 (-0.90 to +0.77)

-0.01 (-0.36 to +0.34)

Baseline CD4 (copies/mm3)

<250

>250

14/619

(2.26)

20/4304

(0.46)

7/627

(1.12)

28/4256

(0.66)

1.15 (-0.30 to +2.59)

-0.19 (-0.51 to +0.12)

Sex

Men

Women

12/2300

(0.52)

22/2622

(0.84)

17/2285

(0.74)

18/2599

(0.69)

-0.22 (-0.68 to +0.24

0.15 (-0.33 to +0.62)


Comment

The effectiveness of current TB prophylaxis for people with HIV is limited by the difficulties of taking nine months of isoniazid -- despite their dramatically higher need for this protection.

These results are likely to change management of HIV in people with latent TB or in high TB incidence settings.


Reference

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.
www.croiwebcasts.org/console/player/37077 (webcast)

[Note from TheBodyPRO: This article was originally published by HIV i-Base on March 5, 2018. We have cross-posted it with their permission.]


Related Stories

Once-Daily Tenofovir Alafenamide Appears Sufficient When Dosed With Rifampicin



This article was provided by HIV i-Base. It is a part of the publication The 25th Conference on Retroviruses and Opportunistic Infections. Visit HIV i-Base's website to find out more about their activities, publications and services.
 


No comments have been made.
 

Add Your Comment:
(Please note: Your name and comment will be public, and may even show up in
Internet search results. Be careful when providing personal information! Before
adding your comment, please read TheBody.com's Comment Policy.)

Your Name:


Your Location:

(ex: San Francisco, CA)

Your Comment:

Characters remaining:


Please note: Knowledge about HIV changes rapidly. Note the date of this summary's publication, and before treating patients or employing any therapies described in these materials, verify all information independently. If you are a patient, please consult a doctor or other medical professional before acting on any of the information presented in this summary. For a complete listing of our most recent conference coverage, click here.

Advertisement

The content on this page is free of advertiser influence and was produced by our editorial team. See our content and advertising policies.