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Meta-Analysis
. 2013 Jul 5;2013(7):CD007545.
doi: 10.1002/14651858.CD007545.pub2.

Rifamycins (rifampicin, rifabutin and rifapentine) compared to isoniazid for preventing tuberculosis in HIV-negative people at risk of active TB

Surendra K Sharma  1 , Anju Sharma, Tamilarasu Kadhiravan, Prathap Tharyan
Affiliations
Meta-Analysis

Rifamycins (rifampicin, rifabutin and rifapentine) compared to isoniazid for preventing tuberculosis in HIV-negative people at risk of active TB

Surendra K Sharma et al. Cochrane Database Syst Rev. .

Abstract

Background: Preventing active tuberculosis (TB) from developing in people with latent tuberculosis infection (LTBI) is important for global TB control. Isoniazid (INH) for six to nine months has 60% to 90% protective efficacy, but the treatment period is long, liver toxicity is a problem, and completion rates outside trials are only around 50%. Rifampicin or rifamycin-combination treatments are shorter and may result in higher completion rates.

Objectives: To compare the effects of rifampicin monotherapy or rifamycin-combination therapy versus INH monotherapy for preventing active TB in HIV-negative people at risk of developing active TB.

Search methods: We searched the Cochrane Infectious Disease Group Specialized Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; LILACS; clinical trials registries; regional databases; conference proceedings; and references, without language restrictions to December 2012; and contacted experts for relevant published, unpublished and ongoing trials.

Selection criteria: Randomized controlled trials (RCTs) of HIV-negative adults and children at risk of active TB treated with rifampicin, or rifamycin-combination therapy with or without INH (any dose or duration), compared with INH for six to nine months.

Data collection and analysis: At least two authors independently screened and selected trials, assessed risk of bias, and extracted data. We sought clarifications from trial authors. We pooled relative risks (RRs) with their 95% confidence intervals (CIs), using a random-effects model if heterogeneity was significant. We assessed overall evidence quality using the GRADE approach.

Main results: Ten trials are included, enrolling 10,717 adults and children, mostly HIV-negative (2% HIV-positive), with a follow-up period ranging from two to five years. Rifampicin (three/four months) vs. INH (six months)Five trials published between 1992 to 2012 compared these regimens, and one small 1992 trial in adults with silicosis did not detect a difference in the occurrence of TB over five years of follow up (one trial, 312 participants; very low quality evidence). However, more people in these trials completed the shorter course (RR 1.19, 95% CI 1.01 to 1.30; five trials, 1768 participants; moderate quality evidence). Treatment-limiting adverse events were not significantly different (four trials, 1674 participants; very low quality evidence), but rifampicin caused less hepatotoxicity (RR 0.12, 95% CI 0.05 to 0.30; four trials, 1674 participants; moderate quality evidence). Rifampicin plus INH (three months) vs. INH (six months)The 1992 silicosis trial did not detect a difference between people receiving rifampicin plus INH compared to INH alone for occurrence of active TB (one trial, 328 participants; very low quality evidence). Adherence was similar in this and a 1998 trial in people without silicosis (two trials, 524 participants; high quality evidence). No difference was detected for treatment-limiting adverse events (two trials, 536 participants; low quality evidence), or hepatotoxicity (two trials, 536 participants; low quality evidence). Rifampicin plus pyrazinamide (two months) vs. INH (six months)Three small trials published in 1994, 2003, and 2005 compared these two regimens, and two reported a low occurrence of active TB, with no statistically significant differences between treatment regimens (two trials, 176 participants; very low quality evidence) though, apart from one child from the 1994 trial, these data on active TB were from the 2003 trial in adults with silicosis. Adherence with both regimens was low with no statistically significant differences (four trials, 700 participants; very low quality evidence). However, people receiving rifampicin plus pyrazinamide had more treatment-limiting adverse events (RR 3.61, 95% CI 1.82 to 7.19; two trials, 368 participants; high quality evidence), and hepatotoxicity (RR 4.59, 95% 2.14 to 9.85; three trials, 540 participants; moderate quality evidence). Weekly, directly-observed rifapentine plus INH (three months) vs. daily, self-administered INH (nine months)A large trial conducted from 2001 to 2008 among close contacts of TB in the USA, Canada, Brazil and Spain found directly observed weekly treatment to be non-inferior to nine months self-administered INH for the incidence of active TB (0.2% vs 0.4%, RR 0.44, 95% CI 0.18 to 1.07, one trial, 7731 participants; moderate quality evidence). The directly-observed, shorter regimen had higher treatment completion (82% vs 69%, RR 1.19, 95% CI 1.16 to 1.22, moderate quality evidence), and less hepatotoxicity (0.4% versus 2.4%; RR 0.16, 95% CI 0.10 to 0.27; high quality evidence), though treatment-limiting adverse events were more frequent (4.9% versus 3.7%; RR 1.32, 95% CI 1.07 to 1.64 moderate quality evidence)

Authors' conclusions: Trials to date of shortened prophylactic regimens using rifampicin alone have not demonstrated higher rates of active TB when compared to longer regimens with INH. Treatment completion is probably higher and adverse events may be fewer with shorter rifampicin regimens. Shortened regimens of rifampicin with INH may offer no advantage over longer INH regimens. Rifampicin combined with pyrazinamide is associated with more adverse events. A weekly regimen of rifapentine plus INH has higher completion rates, and less liver toxicity, though treatment discontinuation due to adverse events is probably more likely than with INH.

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Conflict of interest statement

None of the authors declare financial or academic conflicts of interest.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Forest plot of comparison: 1 Rifampicin versus INH, outcome: 1.3 Adherence.
4
4
Forest plot of comparison: 1 Rifampicin versus INH, outcome: 1.6 Hepatotoxicity.
5
5
Forest plot of comparison: 3 Rifampicin plus pyrazinamide versus INH, outcome: 3.3 Adherence.
6
6
Forest plot of comparison: 3 Rifampicin plus pyrazinamide versus INH, outcome: 3.5 Hepatotoxicity.
1.1
1.1. Analysis
Comparison 1 Rifampicin versus INH, Outcome 1 Active TB.
1.2
1.2. Analysis
Comparison 1 Rifampicin versus INH, Outcome 2 Drug‐resistant TB.
1.3
1.3. Analysis
Comparison 1 Rifampicin versus INH, Outcome 3 Adherence.
1.4
1.4. Analysis
Comparison 1 Rifampicin versus INH, Outcome 4 Serious adverse events: (adults with LTBI).
1.5
1.5. Analysis
Comparison 1 Rifampicin versus INH, Outcome 5 Treatment‐limiting adverse events.
1.6
1.6. Analysis
Comparison 1 Rifampicin versus INH, Outcome 6 Hepatotoxicity.
1.7
1.7. Analysis
Comparison 1 Rifampicin versus INH, Outcome 7 Gastrointestinal Intolerance.
1.8
1.8. Analysis
Comparison 1 Rifampicin versus INH, Outcome 8 Rash.
1.9
1.9. Analysis
Comparison 1 Rifampicin versus INH, Outcome 9 Haematological adverse events (in adults with LTBI).
1.10
1.10. Analysis
Comparison 1 Rifampicin versus INH, Outcome 10 Any adverse event (in adults with silicosis).
2.1
2.1. Analysis
Comparison 2 Rifampicin plus INH versus INH, Outcome 1 Active TB: INH plus rifampicin 3 months versus INH 6 months (in adults with silicosis).
2.2
2.2. Analysis
Comparison 2 Rifampicin plus INH versus INH, Outcome 2 Drug‐resistant TB.
2.3
2.3. Analysis
Comparison 2 Rifampicin plus INH versus INH, Outcome 3 Adherence.
2.4
2.4. Analysis
Comparison 2 Rifampicin plus INH versus INH, Outcome 4 Serious adverse events: INH plus rifampicin 3 months versus INH 9 months (in adults).
2.5
2.5. Analysis
Comparison 2 Rifampicin plus INH versus INH, Outcome 5 Treatment‐limiting adverse events.
2.6
2.6. Analysis
Comparison 2 Rifampicin plus INH versus INH, Outcome 6 Hepatotoxicity.
2.7
2.7. Analysis
Comparison 2 Rifampicin plus INH versus INH, Outcome 7 Gastrointestinal intolerance.
2.8
2.8. Analysis
Comparison 2 Rifampicin plus INH versus INH, Outcome 8 Any adverse event: INH plus rifampicin 3 months versus INH 6 months (in adults with silicosis).
3.1
3.1. Analysis
Comparison 3 Rifampicin plus pyrazinamide versus INH, Outcome 1 Active TB.
3.2
3.2. Analysis
Comparison 3 Rifampicin plus pyrazinamide versus INH, Outcome 2 Drug‐resistant TB.
3.3
3.3. Analysis
Comparison 3 Rifampicin plus pyrazinamide versus INH, Outcome 3 Adherence.
3.4
3.4. Analysis
Comparison 3 Rifampicin plus pyrazinamide versus INH, Outcome 4 Treatment‐limiting adverse events (in adults).
3.5
3.5. Analysis
Comparison 3 Rifampicin plus pyrazinamide versus INH, Outcome 5 Hepatotoxicity.
3.6
3.6. Analysis
Comparison 3 Rifampicin plus pyrazinamide versus INH, Outcome 6 At least one adverse event (in adults).
3.7
3.7. Analysis
Comparison 3 Rifampicin plus pyrazinamide versus INH, Outcome 7 Gastrointestinal Intolerance (in adults).
3.8
3.8. Analysis
Comparison 3 Rifampicin plus pyrazinamide versus INH, Outcome 8 Rash (in adults).
3.9
3.9. Analysis
Comparison 3 Rifampicin plus pyrazinamide versus INH, Outcome 9 Pruritus (in adults).
4.1
4.1. Analysis
Comparison 4 Rifapentine plus INH weekly for 3 months versus INH daily for 9 months, Outcome 1 Active TB.
4.2
4.2. Analysis
Comparison 4 Rifapentine plus INH weekly for 3 months versus INH daily for 9 months, Outcome 2 All‐cause mortality.
4.3
4.3. Analysis
Comparison 4 Rifapentine plus INH weekly for 3 months versus INH daily for 9 months, Outcome 3 Drug‐resistant TB.
4.4
4.4. Analysis
Comparison 4 Rifapentine plus INH weekly for 3 months versus INH daily for 9 months, Outcome 4 Adherence.
4.5
4.5. Analysis
Comparison 4 Rifapentine plus INH weekly for 3 months versus INH daily for 9 months, Outcome 5 Serious adverse events.
4.6
4.6. Analysis
Comparison 4 Rifapentine plus INH weekly for 3 months versus INH daily for 9 months, Outcome 6 Treatment‐limiting adverse events.
4.7
4.7. Analysis
Comparison 4 Rifapentine plus INH weekly for 3 months versus INH daily for 9 months, Outcome 7 Hypersensitivity.
4.8
4.8. Analysis
Comparison 4 Rifapentine plus INH weekly for 3 months versus INH daily for 9 months, Outcome 8 Hepatotoxicity.
4.9
4.9. Analysis
Comparison 4 Rifapentine plus INH weekly for 3 months versus INH daily for 9 months, Outcome 9 Rash.
4.10
4.10. Analysis
Comparison 4 Rifapentine plus INH weekly for 3 months versus INH daily for 9 months, Outcome 10 Any adverse event.
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Samandari 2011 {published data only}
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References to studies awaiting assessment

White 2012 {published and unpublished data}
    1. NCT00128206. Treatment of Latent TB Infection for Jailed Persons. http://clinicaltrials.gov/ct2/show/NCT00128206 (Accessed 10 May 2012).
    1. White MC, Tulsky JP, Lee JR, Chen L, Goldenson J, Spetz J, et al. Isoniazid versus rifampin for latent tuberculosis infection in jail inmates: toxicity and adherence. Journal of Correctional Health Care 2012;18(2):131‐42. - PMC - PubMed

References to ongoing studies

ISRCTN53253537 {published data only}
    1. Menzies D. A randomized trial to compare completion and tolerability of 4 months rifampin (4 Rif) and 9 months isoniazid (9 INH) in treatment of latent TB in children. http://www.controlled‐trials.com/ISRCTN53253537 Accessed 14 November 2010.
NCT00023452 {published data only}
    1. CDC fact sheet. PREVENT TB study. http://www.cdc.gov/nchhstp/newsroom/docs/PREVENT‐TB‐Factsheet.pdf 2011; Vol. May:1‐2 (Accessed 14 November 2011).
    1. Sterling T, Villarino E. TBTC study 26: weekly Rifapentine + INH for 3 months versus daily INH for 9 months for the treatment of LTBI. http://clinicaltrials.gov/show/NCT00023452 (Accessed 14 November 2011).
NCT00931736 {published data only}
    1. Menzies D. A randomized clinical trial comparing 4RIF versus 9INH for treatment of latent tuberculosis infection (LTBI) ‐ effectiveness. http://clinicaltrials.gov/show/NCT00931736 (Accessed 14 November 2011).
NCT01398618 {published data only}
    1. Wang JY. Comparing the efficacy of two preventive regimens for adult household contacts with latent tuberculosis infection. http://clinicaltrials.gov/ct2/show/record/NCT01398618 (Accessed 15 April 2012).

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