Is 6 months of bedaquiline enough? Results from the compassionate use of bedaquiline in Armenia and Georgia
| Autor: | Yegiazaryan L, Naira Khachatryan, Helena Huerga, Atshemyan H, Mathieu Bastard, Chumburidze N, N. Kiria, Armen Hayrapetyan, Zaza Avaliani, Tinatin Kotrikadze, Francis Varaine, Kirakosyan O, Cathy Hewison, N Lachenal, Qayyum S |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Compassionate Use Trials Male Pulmonary and Respiratory Medicine medicine.medical_specialty Georgia Tuberculosis Antitubercular Agents Logistic regression Cohort Studies 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Risk Factors Internal medicine Tuberculosis Multidrug-Resistant medicine Culture conversion Humans 030212 general & internal medicine Diarylquinolines Adverse effect Retrospective Studies Coinfection business.industry Compassionate Use Armenia Middle Aged medicine.disease Hepatitis C Logistic Models Treatment Outcome Infectious Diseases 030228 respiratory system chemistry Cohort Female Bedaquiline business Fluoroquinolones Follow-Up Studies |
| Zdroj: | The International Journal of Tuberculosis and Lung Disease. 22:766-772 |
| ISSN: | 1027-3719 |
| DOI: | 10.5588/ijtld.17.0840 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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