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Open Access Is 6 months of bedaquiline enough? Results from the compassionate use of bedaquiline in Armenia and Georgia

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BACKGROUND AND SETTING: Bedaquiline (BDQ) was initially only available through compassionate use programmes.

OBJECTIVE: To assess the effectiveness and safety of multidrug-resistant tuberculosis (MDR-TB) treatment containing BDQ.

METHOD: Retrospective analysis of data from patients receiving BDQ through compassionate use in Armenia and Georgia from April 2013 to April 2015. Logistic regression was used to assess the risk factors associated with unsuccessful treatment outcomes.

RESULTS: Of 82 patients included, 84.2% (69/82) had fluoroquinolone-resistant MDR-TB and 43.4% (23/53) were seropositive for the hepatitis C virus (HCV). The culture conversion rate was 84.4% (54/64), and 18.5% (10/54) reverted back to positive. In total, 79.3% (65/82) of the patients reported at least one adverse event. Serious adverse events were reported in 14 patients, with 10/14 patients experiencing fatal outcomes—6/10 related to advanced TB and 2/10 assessed as possibly related to BDQ. Treatment outcomes were as follows: 58.5% treatment success, 12.2% deaths, 7.3% failures and 21.9% lost to follow-up. HCV coinfection was associated with unsuccessful outcomes (adjusted OR 4.45, 95%CI 1.23–16.13).

CONCLUSION: BDQ through compassionate use showed relatively good success rates and safety profiles in a cohort with difficult-to-treat MDR-TB. High rates of reversion may indicate that >24 weeks of BDQ is necessary in some cases. HCV coinfection should be diagnosed and treatment considered in MDR-TB patients.
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Keywords: MDR-TB; duration; hepatitis C; new anti-tuberculosis drugs; treatment

Document Type: Research Article

Affiliations: 1: Médecins Sans Frontières (MSF), Paris 2: Epicentre, Paris, France 3: MSF, Yerevan, Armenia 4: MSF, Tbilisi, Georgia; 5: National Tuberculosis Control Centre, Yerevan, Armenia 6: National Centre for Tuberculosis and Lung Disease, Tbilisi, Georgia 7: Migration Health Department, International Organization for Migration, Amman, Jordan, MSF, Yerevan, Armenia 8: MSF, Geneva, Switzerland

Publication date: 01 July 2018

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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