SER-109 (VOWST™) : A Review in the Prevention of Recurrent Clostridioides difficile Infection
© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG..
SER-109 (VOWST™; fecal microbiota spores, live-brpk) is a live biotherapeutic product indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in patients 18 years of age and older following standard of care (SOC) antibacterial treatment for recurrent CDI. It is a purified bacterial spore suspension sourced from healthy donors. As the first oral faecal microbiota product approved for prevention of recurrent CDI, SER-109 is administered as four capsules once daily for three consecutive days. In a well-designed, placebo-controlled, phase III trial (ECOSPOR III), SER-109 significantly reduced the risk of recurrent CDI at 8 weeks post-treatment, with a durable response seen at 6 months post-treatment. Treatment with SER-109 was also associated with rapid and steady improvement in health-related quality of life compared with placebo. SER-109 was generally well tolerated, with a safety profile similar to that of placebo. The most common adverse events were of mild to moderate severity and generally gastrointestinal in nature. Thus, with the convenience of oral administration and lack of necessity for cold storage, SER-109 is a valuable option for preventing further CDI recurrence in adults following antibacterial treatment for recurrent CDI.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:84 |
|---|---|
| Enthalten in: |
Drugs - 84(2024), 3 vom: 02. März, Seite 329-336 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Blair, Hannah A [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
|---|
| Anmerkungen: |
Date Completed 02.04.2024 Date Revised 02.04.2024 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1007/s40265-024-02006-7 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM369316630 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM369316630 | ||
| 003 | DE-627 | ||
| 005 | 20240403000400.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240305s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s40265-024-02006-7 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1361.xml |
| 035 | |a (DE-627)NLM369316630 | ||
| 035 | |a (NLM)38441806 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Blair, Hannah A |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a SER-109 (VOWST™) |b A Review in the Prevention of Recurrent Clostridioides difficile Infection |
| 264 | 1 | |c 2024 | |
| 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 02.04.2024 | ||
| 500 | |a Date Revised 02.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG. | ||
| 520 | |a SER-109 (VOWST™; fecal microbiota spores, live-brpk) is a live biotherapeutic product indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in patients 18 years of age and older following standard of care (SOC) antibacterial treatment for recurrent CDI. It is a purified bacterial spore suspension sourced from healthy donors. As the first oral faecal microbiota product approved for prevention of recurrent CDI, SER-109 is administered as four capsules once daily for three consecutive days. In a well-designed, placebo-controlled, phase III trial (ECOSPOR III), SER-109 significantly reduced the risk of recurrent CDI at 8 weeks post-treatment, with a durable response seen at 6 months post-treatment. Treatment with SER-109 was also associated with rapid and steady improvement in health-related quality of life compared with placebo. SER-109 was generally well tolerated, with a safety profile similar to that of placebo. The most common adverse events were of mild to moderate severity and generally gastrointestinal in nature. Thus, with the convenience of oral administration and lack of necessity for cold storage, SER-109 is a valuable option for preventing further CDI recurrence in adults following antibacterial treatment for recurrent CDI | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Review | |
| 650 | 7 | |a Anti-Bacterial Agents |2 NLM | |
| 773 | 0 | 8 | |i Enthalten in |t Drugs |d 1976 |g 84(2024), 3 vom: 02. März, Seite 329-336 |w (DE-627)NLM00001611X |x 1179-1950 |7 nnns |
| 773 | 1 | 8 | |g volume:84 |g year:2024 |g number:3 |g day:02 |g month:03 |g pages:329-336 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s40265-024-02006-7 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 84 |j 2024 |e 3 |b 02 |c 03 |h 329-336 | ||