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Outcomes of a nine-month regimen for rifampicin-resistant tuberculosis up to 24 months after treatment completion in nine African countries.

ABSTRACT: Background:Treatment outcomes of the shorter regimen for rifampicin-resistant tuberculosis are not completely established. We report on these outcomes two years after treatment completion among patients enrolled in an observational cohort study in nine African countries. Methods:1,006 patients treated with the nine-month regimen were followed every six months with sputum cultures up to 24 months after treatment completion. The risk of any unfavourable outcome, of failure and relapse, and of death during and after treatment was analysed according to patient's characteristics and initial drug susceptibility by Cox proportional hazard models. Findings:Respectively 67.8% and 57.2% patients had >=1 culture result six months and 12 months after treatment completion. Fourteen relapses were diagnosed. The probability of relapse-free success was 79.3% (95% confidence interval [CI] 76.6-82.0%) overall, 80.9% (95% CI 78.0-84.0%) among HIV-negative and 72.5% (95% CI 66.5-78.9%) among HIV-infected patients. Initial fluoroquinolone (adjusted hazard ratio [aHR] 6.7 [95% CI 3.4-13.1]) and isoniazid resistance (aHR 9.4 [95% CI 1.3-68.0]) were significantly associated with increased risk of failure/relapse and of any unfavourable outcome. Interpretation:The close to 80% relapse-free success indicates the good outcome of the regimen in low-and middle-income settings. Results confirm the lesser effectiveness of the regimen in patients with initial resistance to fluoroquinolones and support the use of high-dose isoniazid, but do not support exclusion of patients for resistance to drugs other than fluoroquinolones. Funding:Expertise-France and Agence Française de Développement.

SUBMITTER: Schwœbel V

PROVIDER: S-EPMC7152829 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Outcomes of a nine-month regimen for rifampicin-resistant tuberculosis up to 24 months after treatment completion in nine African countries.

Schwœbel Valérie V Trébucq Arnaud A Kashongwe Zacharie Z Bakayoko Alimata S AS Kuaban Christopher C Noeske Juergen J Harouna Souleymane H SH Souleymane Mahamadou B MB Piubello Alberto A Ciza François F Fikouma Valentin V Gasana Michel M Ouedraogo Martial M Gninafon Martin M Van Deun Armand A Tagliani Elisa E Cirillo Daniela M DM Koura Kobto G KG Rieder Hans L HL

EClinicalMedicine 20200210

<h4>Background</h4>Treatment outcomes of the shorter regimen for rifampicin-resistant tuberculosis are not completely established. We report on these outcomes two years after treatment completion among patients enrolled in an observational cohort study in nine African countries.<h4>Methods</h4>1,006 patients treated with the nine-month regimen were followed every six months with sputum cultures up to 24 months after treatment completion. The risk of any unfavourable outcome, of failure and relap ...[more]

PMID: 32300732

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Project description:BackgroundGlobally, drug resistant tuberculosis (DR-TB) continues to be a public health threat. Nigeria, which accounts for a significant proportion of the global burden of rifampicin/multi-drug resistant-TB (RR/MDR-TB) had a funding gap of $168 million dollars for TB treatment in 2018. Since 2010, Nigeria has utilized five different models of care for RR/MDR-TB (Models A-E); Models A, B and C based on a standardized WHO-approved treatment regimen of 20-24 months, were phased out between 2015 and 2019 and replaced by Models D and E. Model D is a fully ambulatory model of 9-12 months during which a shorter treatment regimen including a second-line injectable agent is utilized. Model E is identical to Model D but has patients hospitalized for the first four months of care while Model F which is to be introduced in 2020, is a fully ambulatory, oral bedaquiline-containing shorter treatment regimen of 9-12 months. Treatment models for RR/MDR-TB of 20-24 months duration have had treatment success rates of 52-66% while shorter treatment regimens have reported success rates of 85% and above. In addition, replacing the second-line injectable agent in a shorter treatment regimen with bedaquiline has been found to further improve treatment success in patients with fluoroquinolone-susceptible RR/MDR-TB. Reliable cost data for RR/MDR-TB care are limited, specifically costs of models that utilize shorter treatment regimens and which are vital to guide Nigeria through the provision of RR/MDR-TB care at scale. We therefore conducted a cost analysis of shorter treatment regimens in use and to be used in Nigeria (Models D, E and F) and compared them to three models of longer duration utilized previously in Nigeria (Models A, B and C) to identify any changes in cost from transitioning from Models A-C to Models D-F and opportunities for cost savings.MethodsWe obtained costs for TB diagnostic and monitoring tests, in-patient and out-patient care from a previous study, inflated these costs to 2019 NGN and then converted to 2020 USD. We obtained other costs from the average of six health facilities and drug costs from the global drug facility. We modeled treatment on strict adherence to two Nigerian National guidelines for programmatic and clinical management of drug-resistant tuberculosis.ResultsWe estimated that the total costs of care from the health sector perspective for Models D, E and F were $4,334, $7,705 and $3,420 respectively. This is significantly lower than the costs of Models A, B and C which were $14,781, $12, 113, $7,572 respectively.ConclusionReplacing Models A-C with Models D and E reduced the costs of RR/MDR-TB care in Nigeria by approximately $5,470 (48%) per patient treated and transitioning from Models D and E to Model F would result in further cost savings of $914 to $4,285 (21 to 56%) for every patient placed on Model F. If the improved outcomes of patients managed using bedaquiline-containing shorter treatment regimens in other countries can be attained in Nigeria, Model F would be the recommended model for the scale up of RR/MDR-TB care in Nigeria.

Project description:BackgroundSince a meta-analysis showed little or no effect of second-line injectables on treatment success, and using injectables may induce ototoxicity, injectable-free rifampicin-resistant tuberculosis (RR-TB) treatment regimens are recommended. However, acquired resistance preventing activity was overlooked. No previous study assessed the effect of shortening the duration of kanamycin administration to 2 months during the intensive phase of the RR-TB shorter treatment regimen (STR).MethodsRetrospective cohort study of the effect of using 2 months of kanamycin instead of the standard 4(+) months (extension if lack of smear conversion at 4 months) on recurrence (either treatment failure or relapse) and fluoroquinolone acquired drug resistance, in patients treated with a gatifloxacin-based STR in Damien Foundation supported clinics in Bangladesh. Logistic regression was used to estimate associations.ResultsFive of 52 (9.6%) treated with a STR containing two months of kanamycin had recurrence, compared to 21 of 738 (2.8%) patients treated with the standard STR containing 4(+) months of kanamycin (OR 3.7; 95%CI:1.5-10.3). In those with initially fluoroquinolone-susceptible TB, acquired resistance to fluoroquinolone was detected in none of 639 patients treated with 4(+) months of kanamycin and two (4.5%) of 44 treated with two months of kanamycin (OR 75.2; 95%CI:3.6-1592.1).ConclusionTwo months of kanamycin was insufficient to prevent recurrence with acquired resistance to gatifloxacin, the core drug of the most effective RR-TB STR. Injectable mediated resistance prevention is important to reach high effectiveness, to safeguard all treatment options after recurrence, and to prevent the spread of resistant TB. Studies on all-oral regimens should also assess the effect of regimen composition on resistance acquisition. Until evidence shows that other drugs can assure at least the same strong resistance preventing activity of the injectables, it seems wise to continue using this group of drugs, and adapt the regimen if any ototoxicity is detected.

Project description:BackgroundHIV-related stigmatisation and discrimination by young children towards their peers have important consequences at the individual level and for our response to the epidemic, yet research on this area is limited.MethodsWe used nationally representative data to examine discrimination of HIV-positive children by grade six students (n?=?39,664) across nine countries in Southern Africa: Botswana, Lesotho, Malawi, Mozambique, Namibia, South Africa, Swaziland, Zambia and Zimbabwe. Descriptive statistics are used to compare discrimination by country, gender, geographic location and socioeconomic status. Multivariate logistic regression is employed to assess potential determinants of discrimination.ResultsThe levels and determinants of discrimination varied significantly between the nine countries. While one in ten students in Botswana, Malawi, South Africa and Swaziland would "avoid or shun" an HIV positive friend, the proportions in Lesotho, Mozambique, Zambia and Zimbabwe were twice as high (approximately 20%). A large proportion of students believed that HIV positive children should not be allowed to continue to attend school, particularly in Zambia (33%), Lesotho (37%) and Zimbabwe (42%). The corresponding figures for Malawi and Swaziland were significantly lower at 13% and 12% respectively. Small differences were found by gender. Children from rural areas and poorer schools were much more likely to discriminate than those from urban areas and wealthier schools. Importantly, we identified factors consistently associated with discrimination across the region: students with greater exposure to HIV information, better general HIV knowledge and fewer misconceptions about transmission of HIV via casual contact were less likely to report discrimination.ConclusionsOur study points toward the need for early interventions (grade six or before) to reduce stigma and discrimination among children, especially in schools situated in rural areas and poorer communities. In particular, interventions should focus on correcting misconceptions that HIV can be transmitted via casual contact.

Project description:BackgroundThere is ample evidence that gender norms affect contraceptive practice; however, data are mostly qualitative with limited geographical scope. We investigated that association quantitatively using collective community-level attitudes towards premarital sex and wife-beating as proxies for gender norms.MethodsData came from nationally representative Demographic and Health Surveys (2005-2009) for women of reproductive age (15-49 years) in nine sub-Saharan African countries. Using multilevel logistic models, controlling for individual covariates and community-level indicators of women's empowerment, we assessed the community-level association of gender norms regarding premarital sex and wife-beating with individual contraception uptake and demand satisfied among fecund sexually active women. Norms were approximated as 'collective attitudinal norms' from female/male residents (aged 15-49 years) from the same community. We assessed the magnitude and significance of the community-level effects and attributed variance across communities. The same analysis was replicated for each country.ResultsIn a fully-adjusted model with a pooled sample of 24 404 adolescent women, the odds of contraception use increased with a 1 standard deviation (SD) increase in the variation of collective permissive attitudes towards premarital sex of female (odds ratio (OR) = 1.08, 95% confidence interval (CI) = 1.02-1.15) and male (OR = 1.11, 95% CI = 1.05-1.17) peers (15-24 years), while odds of contraceptive use declined by 10% (OR = 0.90, 95% CI = 0.85-0.96) with collective accepting attitudes towards wife-beating of women aged 15-49 years. Similar results were found in separate models that controlled for adults' permissive attitudes towards premarital sex. The community-level attributed variance (V2 = 1.62, 95% CI = 1.45-1.80) represented 33% (intra-class correlation (ICC) = 33.0, 95% CI = 30.0-35.4) of the total variation of contraception use, and attitudes towards premarital sex and violence jointly explained nearly 26% of that V2 variance. The community-level shared of attributed variation of contraceptive use varied significantly across countries, from 3.5% in Swaziland (ICC = 3.5, 95% CI = 0.8-13.7) to 60.2% in Nigeria (OR = 60.2, 95% CI = 56.0-64.2).ConclusionsOverall, significant positive associations of collective permissive attitudes of both adolescent and adult women towards premarital sex were found for use of, and demand for, contraception, whereas collective accepting attitudes towards wife-beating were negatively associated with the use and demand for contraception. Ours is the first study to define quantitatively the influence of proxies for gender norms at the community level on women's family planning decisions. These findings offer new insights for understanding the role of sex-related attitudes and norms as important factors in shaping contraceptive practices and improving the effectiveness of family planning policies by targeting individuals as well as their groups of influence.

Dataset Information

Outcomes of a nine-month regimen for rifampicin-resistant tuberculosis up to 24 months after treatment completion in nine African countries.

Publications

Outcomes of a nine-month regimen for rifampicin-resistant tuberculosis up to 24 months after treatment completion in nine African countries.

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