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Exposure to Latent Tuberculosis Treatment during Pregnancy. The PREVENT TB and the iAdhere Trials.

ABSTRACT: RATIONALE:Data are limited regarding the safety of 12-dose once-weekly isoniazid (H, 900 mg) plus rifapentine (P, 900 mg) (3HP) for latent infection treatment during pregnancy. OBJECTIVES:To assess safety and pregnancy outcomes among pregnant women who were inadvertently exposed to study medications in two latent tuberculosis infection trials (PREVENT TB or iAdhere) evaluating 3HP and 9 months of daily isoniazid (H, 300 mg) (9H). METHODS:Data from reproductive-age (15-51 yr) women who received one or more study dose of 3HP or 9H in either trial were analyzed. Drug exposure during pregnancy occurred if the estimated date of conception was on or before the last dose date. RESULTS:Of 126 pregnancies (125 participants) that occurred during treatment or follow-up, 87 were exposed to study drugs. Among these, fetal loss was reported for 4/31 (13%) and 8/56 (14%), 3HP and 9H, respectively (difference, 13% - 14% = -1%; 95% confidence interval = -17% to +18%) and congenital anomalies in 0/20 and 2/41 (5%) live births, 3HP and 9H, respectively (difference, 0% - 5% = -5%; 95% confidence interval = -18% to +16%). All fetal losses occurred in pregnancies of less than 20 weeks. Of the total 126 pregnancies, fetal loss was reported in 8/54 (15%) and 9/72 (13%), 3HP and 9H, respectively; and congenital anomalies in 1/37 (3%) and 2/56 (4%) live births, 3HP and 9H, respectively. The overall proportion of fetal loss (17/126 [13%]) and anomalies (3/93 [3%]) were similar to those estimated for the United States, 17% and 3%, respectively. CONCLUSIONS:Among reported pregnancies in these two latent tuberculosis infection trials, there was no unexpected fetal loss or congenital anomalies. These data offer some preliminary reassurance to clinicians and patients in circumstances when these drugs and regimens are the best option in pregnancy or in women of child-bearing potential. This work used the identifying trial registration numbers NCT00023452 and NCT01582711, corresponding to the primary clinical trials PREVENT TB and iAdhere (Tuberculosis Trials Consortium Study 26 and 33).

SUBMITTER: Moro RN

PROVIDER: S-EPMC6624829 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundIn countries with low tuberculosis (TB) incidence, immigrants from higher incidence countries represent the major pool of individuals with latent TB infection (LTBI). The antenatal period represents an opportunity for immigrant women to access the medical system, and hence for potential screening and treatment of LTBI. However, such screening and treatment during pregnancy remains controversial.ObjectivesIn order to further understand the prevalence, natural history, screening and management of LTBI in pregnancy, we conducted a systematic literature review addressing the screening and treatment of LTBI, in pregnant women without known HIV infection.MethodsA systematic review of 4 databases (Embase, Embase Classic, Medline, Cochrane Library) covering articles published from January 1st 1980 to April 30th 2014. Articles in English, French or Spanish with relevant information on prevalence, natural history, screening tools, screening strategies and treatment of LTBI during pregnancy were eligible for inclusion. Articles were excluded if (1) Full text was not available (2) they were case series or case studies (3) they focused exclusively on prevalence, diagnosis and treatment of active TB (4) the study population was exclusively HIV-infected.ResultsOf 4,193 titles initially identified, 208 abstracts were eligible for review. Of these, 30 articles qualified for full text review and 22 were retained: 3 cohort studies, 2 case-control studies, and 17 cross-sectional studies. In the USA, the estimated prevalence of LTBI ranged from 14 to 48% in women tested, and tuberculin skin test (TST) positivity was associated with ethnicity. One study suggested that incidence of active TB was significantly increased during the 180 days postpartum (Incidence rate ratio, 1.95 (95% CI 1.24-3.07). There was a high level of adherence with both skin testing (between 90-100%) and chest radiography (93-100%.). In three studies from low incidence settings, concordance between TST and an interferon-gamma release assay was 77, 88 and 91% with kappa values ranging from 0.26 to 0.45. In low incidence settings, an IGRA may be more specific and less sensitive than TST, and results do not appear to be altered by pregnancy. The proportion of women who attended follow-up visits after positive tuberculin tests varied from 14 to 69%, while 5 to 42% of those who attended follow-up visits completed a minimum of 6 months of isoniazid treatment. One study raised the possibility of an association of pregnancy/post-partum state with INH hepatitis (risk ratio 2,5, 95% CI 0.8-8.2) and fatal hepatotoxicity (rate ratio 4.0, 95% CI 0.2-258). One study deemed INH safe during breastfeeding based on peak concentrations in plasma and breast milk after INH administration.ConclusionPregnancy is an opportunity to screen for LTBI. Interferon-gamma release assays are likely comparable to tuberculin skin tests and may be used during pregnancy. Efforts should be made to improve adherence with follow-up and treatment post-partum. Further data are needed with respect to safety and feasibility of antepartum INH therapy, and with respect to alternative treatment regimens.

Project description:Objective and methodManagement of latent tuberculosis infection (LTBI) is one of the core elements of End TB Strategy. Japan is one of the few countries in which notification of LTBI is mandatory, yet so far, the data has not been analyzed in detail. We thus conducted a cross-sectional study to examine the trend of LTBI, its treatment outcome and factors predicting treatment non-completion in Japan for the period of 2007 and 2014, using the data from the electronic Japan Tuberculosis Surveillance system. Treatment completion was defined as those whose reason for terminating the treatment was recorded as "treatment completed" and whose treatment duration was 180 days or more.ResultsDuring the study period, a total of 50,268 LTBI patients were notified, of which 49,525, who had started treatment, were analyzed for characteristics. 57.5% were females, and 38.5% were aged 25-44 years. As for the job category, healthcare professionals, that is medical doctors, nurses and other healthcare workers, consisted the largest group (30.4%). Overall, the number of LTBI notification has been on an increase, with a large increase observed among those aged 65 years and above. Of the 49,525 patients, the information regarding reason for termination of treatment was available for 46,128 (93.1%). Of them, 33,156 (71.9%) had completed treatment as according to the study definition. The risk factors for not completing LTBI treatment included being aged 65 years and above (adjusted odds ratio [aOR] 1.27, 95% confidence interval [95%CI] 1.10-1.47), foreign-born (aOR 1.14, 95%CI 1.02-1.28), healthcare professional (aOR 1.44, 95%CI 1.24-1.69), full-time and part-time worker (aOR 1.40, 95%CI, 1.20-1.63) and detected via contact investigation (aOR 1.26, 95%CI 1.12-1.41).ConclusionsOur study results revealed that the treatment completion rate was 71.9%, falling short of the national target of 85%, and also that the treatment duration was recorded as less than 180 days for approximately 20% of those who were reported as having completed treatment. Further studies may be built on ours to explore the reasons for not completing the treatment across different population groups, and identify those who benefit the most, and who has the greatest impact on ending TB, by receiving LTBI treatment.

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Exposure to Latent Tuberculosis Treatment during Pregnancy. The PREVENT TB and the iAdhere Trials.

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