A prospective patient registry to monitor safety, effectiveness, and utilisation of bedaquiline in patients with multidrug-resistant tuberculosis in South Korea
© 2022. The Author(s)..
BACKGROUND: Multidrug-resistant tuberculosis (MDR-TB) represents a major public health concern, with an ongoing need for new effective treatments. Bedaquiline is an oral diarylquinoline that has shown encouraging treatment success and culture conversion rates in MDR-TB.
METHODS: A South Korean patient registry was set up across 19 centres between 2016 and 2018 for the prospective collection of data from patients with MDR-TB who received either a bedaquiline-containing or a non-bedaquiline-containing regimen. Treatment was at the physician's discretion (bedaquiline use requiring approval by special committee) and was based on patient characteristics, disease status, and local treatment guidelines.
RESULTS: The safety population included 172 patients (88 bedaquiline and 84 non-bedaquiline). The mean (standard deviation, SD) duration of follow-up was 24.3 (9.5) months. Mean (SD) durations of treatment were 5.4 (1.8) months in bedaquiline-treated patients and 15.7 (6.7) months in the non-bedaquiline group. Treatment success (cured and treatment completed according to WHO 2013 treatment outcome definitions) was achieved by 56.3% of bedaquiline-treated and 45.2% of non-bedaquiline-treated patients. Sputum culture conversion rates were 90.4% and 83.7% with and without bedaquiline, respectively. Diarrhoea and nausea were the most frequently reported treatment-emergent adverse events (TEAEs) in the bedaquiline group (27.3% [24/88] and 22.7% [20/88], respectively). The most frequent bedaquiline-related TEAEs were prolonged QT interval (10.2%; 9/88), and diarrhoea and nausea (9.1% each; 8/88). QT interval prolongation was reported in 19.3% (17/88) of bedaquiline-treated and 2.4% (2/84) of non-bedaquiline-treated patients, but bedaquiline was not discontinued for any patient for this reason. There were 13 (14.7%) and three (3.6%) deaths in the bedaquiline-treated and non-bedaquiline groups, respectively. Review of fatal cases revealed no unexpected safety findings, and no deaths were bedaquiline-related. The most common cause of death was worsening cancer (three patients). Patients in the bedaquiline group tended to have poorer baseline risk profiles than non-bedaquiline patients and were more likely to have relapsed or already failed second-line treatment. Interpretation of mortality data was complicated by high rates of loss to follow-up in both groups.
CONCLUSIONS: The South Korean registry findings support previous risk/benefit observations and the continued use of bedaquiline as part of combination therapy in patients with MDR-TB.
Medienart: |
E-Artikel |
---|
Erscheinungsjahr: |
2023 |
---|---|
Erschienen: |
2023 |
Enthalten in: |
Zur Gesamtaufnahme - volume:23 |
---|---|
Enthalten in: |
BMC infectious diseases - 23(2023), 1 vom: 09. Jan., Seite 15 |
Sprache: |
Englisch |
---|
Beteiligte Personen: |
Shim, Tae Sun [VerfasserIn] |
---|
Links: |
---|
Themen: |
Antitubercular Agents |
---|
Anmerkungen: |
Date Completed 11.01.2023 Date Revised 11.01.2023 published: Electronic Citation Status MEDLINE |
---|
doi: |
10.1186/s12879-022-07955-6 |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
NLM351354808 |
---|
LEADER | 01000naa a22002652 4500 | ||
---|---|---|---|
001 | NLM351354808 | ||
003 | DE-627 | ||
005 | 20231226051151.0 | ||
007 | cr uuu---uuuuu | ||
008 | 231226s2023 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1186/s12879-022-07955-6 |2 doi | |
028 | 5 | 2 | |a pubmed24n1171.xml |
035 | |a (DE-627)NLM351354808 | ||
035 | |a (NLM)36624432 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Shim, Tae Sun |e verfasserin |4 aut | |
245 | 1 | 2 | |a A prospective patient registry to monitor safety, effectiveness, and utilisation of bedaquiline in patients with multidrug-resistant tuberculosis in South Korea |
264 | 1 | |c 2023 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ƒaComputermedien |b c |2 rdamedia | ||
338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Date Completed 11.01.2023 | ||
500 | |a Date Revised 11.01.2023 | ||
500 | |a published: Electronic | ||
500 | |a Citation Status MEDLINE | ||
520 | |a © 2022. The Author(s). | ||
520 | |a BACKGROUND: Multidrug-resistant tuberculosis (MDR-TB) represents a major public health concern, with an ongoing need for new effective treatments. Bedaquiline is an oral diarylquinoline that has shown encouraging treatment success and culture conversion rates in MDR-TB | ||
520 | |a METHODS: A South Korean patient registry was set up across 19 centres between 2016 and 2018 for the prospective collection of data from patients with MDR-TB who received either a bedaquiline-containing or a non-bedaquiline-containing regimen. Treatment was at the physician's discretion (bedaquiline use requiring approval by special committee) and was based on patient characteristics, disease status, and local treatment guidelines | ||
520 | |a RESULTS: The safety population included 172 patients (88 bedaquiline and 84 non-bedaquiline). The mean (standard deviation, SD) duration of follow-up was 24.3 (9.5) months. Mean (SD) durations of treatment were 5.4 (1.8) months in bedaquiline-treated patients and 15.7 (6.7) months in the non-bedaquiline group. Treatment success (cured and treatment completed according to WHO 2013 treatment outcome definitions) was achieved by 56.3% of bedaquiline-treated and 45.2% of non-bedaquiline-treated patients. Sputum culture conversion rates were 90.4% and 83.7% with and without bedaquiline, respectively. Diarrhoea and nausea were the most frequently reported treatment-emergent adverse events (TEAEs) in the bedaquiline group (27.3% [24/88] and 22.7% [20/88], respectively). The most frequent bedaquiline-related TEAEs were prolonged QT interval (10.2%; 9/88), and diarrhoea and nausea (9.1% each; 8/88). QT interval prolongation was reported in 19.3% (17/88) of bedaquiline-treated and 2.4% (2/84) of non-bedaquiline-treated patients, but bedaquiline was not discontinued for any patient for this reason. There were 13 (14.7%) and three (3.6%) deaths in the bedaquiline-treated and non-bedaquiline groups, respectively. Review of fatal cases revealed no unexpected safety findings, and no deaths were bedaquiline-related. The most common cause of death was worsening cancer (three patients). Patients in the bedaquiline group tended to have poorer baseline risk profiles than non-bedaquiline patients and were more likely to have relapsed or already failed second-line treatment. Interpretation of mortality data was complicated by high rates of loss to follow-up in both groups | ||
520 | |a CONCLUSIONS: The South Korean registry findings support previous risk/benefit observations and the continued use of bedaquiline as part of combination therapy in patients with MDR-TB | ||
650 | 4 | |a Journal Article | |
650 | 4 | |a Bedaquiline | |
650 | 4 | |a Multidrug-resistant | |
650 | 4 | |a South Korea | |
650 | 4 | |a Tuberculosis | |
650 | 7 | |a Diarylquinolines |2 NLM | |
650 | 7 | |a Antitubercular Agents |2 NLM | |
700 | 1 | |a Pai, Helen |e verfasserin |4 aut | |
700 | 1 | |a Mok, JeongHa |e verfasserin |4 aut | |
700 | 1 | |a Lee, Seung Heon |e verfasserin |4 aut | |
700 | 1 | |a Kwon, Yong-Soo |e verfasserin |4 aut | |
700 | 1 | |a Choi, Jae Chol |e verfasserin |4 aut | |
700 | 1 | |a Park, JaeSeok |e verfasserin |4 aut | |
700 | 1 | |a Birmingham, Eileen |e verfasserin |4 aut | |
700 | 1 | |a Mao, Gary |e verfasserin |4 aut | |
700 | 1 | |a Alquier, Lori |e verfasserin |4 aut | |
700 | 1 | |a Davis, Kourtney |e verfasserin |4 aut | |
700 | 1 | |a Thoret-Bauchet, Florence |e verfasserin |4 aut | |
700 | 1 | |a Kim, Ji Hyun |e verfasserin |4 aut | |
700 | 1 | |a Kim, Hyeongyeong |e verfasserin |4 aut | |
700 | 1 | |a Bakare, Nyasha |e verfasserin |4 aut | |
773 | 0 | 8 | |i Enthalten in |t BMC infectious diseases |d 2001 |g 23(2023), 1 vom: 09. Jan., Seite 15 |w (DE-627)NLM11120089X |x 1471-2334 |7 nnns |
773 | 1 | 8 | |g volume:23 |g year:2023 |g number:1 |g day:09 |g month:01 |g pages:15 |
856 | 4 | 0 | |u http://dx.doi.org/10.1186/s12879-022-07955-6 |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a GBV_NLM | ||
951 | |a AR | ||
952 | |d 23 |j 2023 |e 1 |b 09 |c 01 |h 15 |