Real-World Virological Efficacy and Safety of Ledipasvir and Sofosbuvir in Patients with Chronic Hepatitis C Virus Genotype 2 Infection : A Multicenter Study
INTRODUCTION: The real-world virological efficacy and safety of interferon-free direct-acting antiviral (DAA) therapy with ledipasvir (LDV) plus sofosbuvir (SOF) were assessed in patients who were chronically infected with hepatitis C virus (HCV) genotype 2.
METHODS: A total of 126 patients with chronic hepatitis C due to HCV genotype 2 infection who were treated with the LDV/SOF regimen were enrolled. The sustained virological response (SVR) rate and safety were analyzed. SVR was assessed in the intention-to-treat (ITT) population as well as in the modified intention-to-treat (mITT) population, which excluded patients with non-virological failure, including those who dropped out before the SVR assessment.
RESULTS: The overall SVR rates of the ITT and mITT populations were 87.3% (95% confidence interval [CI] 80.2-92.6) (110/126) and 97.3% (95% CI 92.4-99.4) (110/113), respectively. In the mITT population, the percentages of patients with undetectable HCV RNA at 4, 8, and 12 weeks after the start of therapy were 92.9% (95% CI 86.5-96.9) (105/113), 99.1% (95% CI 95.2-100.0) (112/113), and 100.0% (95% CI 97.4-100.0) (113/113), respectively. Subgroup analyses of the mITT population showed no significant differences in SVR rates according to age, sex, HCV genotype (subtype), history of interferon-based therapy, baseline FIB-4 index, or baseline estimated glomerular filtration rate. In all subpopulations, the SVR rates were > 90%. There were no severe adverse events associated with the treatment.
CONCLUSION: The LDV/SOF regimen showed high virological efficacy and acceptable safety in patients with HCV genotype 2 infection.
TRIAL REGISTRATION: UMIN registration no. 000038604.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2021 |
|---|---|
| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
|---|---|
| Enthalten in: |
Infectious diseases and therapy - 10(2021), 1 vom: 03. März, Seite 269-280 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Tada, Toshifumi [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Genotype 2 |
|---|
| Anmerkungen: |
Date Revised 29.03.2021 published: Print-Electronic Citation Status PubMed-not-MEDLINE |
|---|
| doi: |
10.1007/s40121-020-00364-9 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM317096834 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM317096834 | ||
| 003 | DE-627 | ||
| 005 | 20231225162520.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2021 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s40121-020-00364-9 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1056.xml |
| 035 | |a (DE-627)NLM317096834 | ||
| 035 | |a (NLM)33141401 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Tada, Toshifumi |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Real-World Virological Efficacy and Safety of Ledipasvir and Sofosbuvir in Patients with Chronic Hepatitis C Virus Genotype 2 Infection |b A Multicenter Study |
| 264 | 1 | |c 2021 | |
| 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 Revised 29.03.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a INTRODUCTION: The real-world virological efficacy and safety of interferon-free direct-acting antiviral (DAA) therapy with ledipasvir (LDV) plus sofosbuvir (SOF) were assessed in patients who were chronically infected with hepatitis C virus (HCV) genotype 2 | ||
| 520 | |a METHODS: A total of 126 patients with chronic hepatitis C due to HCV genotype 2 infection who were treated with the LDV/SOF regimen were enrolled. The sustained virological response (SVR) rate and safety were analyzed. SVR was assessed in the intention-to-treat (ITT) population as well as in the modified intention-to-treat (mITT) population, which excluded patients with non-virological failure, including those who dropped out before the SVR assessment | ||
| 520 | |a RESULTS: The overall SVR rates of the ITT and mITT populations were 87.3% (95% confidence interval [CI] 80.2-92.6) (110/126) and 97.3% (95% CI 92.4-99.4) (110/113), respectively. In the mITT population, the percentages of patients with undetectable HCV RNA at 4, 8, and 12 weeks after the start of therapy were 92.9% (95% CI 86.5-96.9) (105/113), 99.1% (95% CI 95.2-100.0) (112/113), and 100.0% (95% CI 97.4-100.0) (113/113), respectively. Subgroup analyses of the mITT population showed no significant differences in SVR rates according to age, sex, HCV genotype (subtype), history of interferon-based therapy, baseline FIB-4 index, or baseline estimated glomerular filtration rate. In all subpopulations, the SVR rates were > 90%. There were no severe adverse events associated with the treatment | ||
| 520 | |a CONCLUSION: The LDV/SOF regimen showed high virological efficacy and acceptable safety in patients with HCV genotype 2 infection | ||
| 520 | |a TRIAL REGISTRATION: UMIN registration no. 000038604 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Genotype 2 | |
| 650 | 4 | |a Hepatitis C virus | |
| 650 | 4 | |a Ledipasvir | |
| 650 | 4 | |a Sofosbuvir | |
| 650 | 4 | |a Sustained virological response | |
| 700 | 1 | |a Kumada, Takashi |e verfasserin |4 aut | |
| 700 | 1 | |a Okushin, Hiroaki |e verfasserin |4 aut | |
| 700 | 1 | |a Tani, Joji |e verfasserin |4 aut | |
| 700 | 1 | |a Takaguchi, Koichi |e verfasserin |4 aut | |
| 700 | 1 | |a Tsutsui, Akemi |e verfasserin |4 aut | |
| 700 | 1 | |a Toyoda, Hidenori |e verfasserin |4 aut | |
| 700 | 1 | |a Yasuda, Satoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Dohmen, Kazufumi |e verfasserin |4 aut | |
| 700 | 1 | |a Hiraoka, Atsushi |e verfasserin |4 aut | |
| 700 | 1 | |a Michitaka, Kojiro |e verfasserin |4 aut | |
| 700 | 1 | |a Nouso, Kazuhiro |e verfasserin |4 aut | |
| 700 | 1 | |a Kariyama, Kazuya |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Soo Ryang |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Soo Ki |e verfasserin |4 aut | |
| 700 | 1 | |a Fujioka, Shinichi |e verfasserin |4 aut | |
| 700 | 1 | |a Mikami, Shigeru |e verfasserin |4 aut | |
| 700 | 1 | |a Watanabe, Yuto |e verfasserin |4 aut | |
| 700 | 1 | |a Tamai, Tsutomu |e verfasserin |4 aut | |
| 700 | 1 | |a Atsukawa, Masanori |e verfasserin |4 aut | |
| 700 | 1 | |a Itokawa, Norio |e verfasserin |4 aut | |
| 700 | 1 | |a Tanaka, Hironori |e verfasserin |4 aut | |
| 700 | 1 | |a Tsuji, Kunihiko |e verfasserin |4 aut | |
| 700 | 1 | |a Ishikawa, Toru |e verfasserin |4 aut | |
| 700 | 1 | |a Imai, Michitaka |e verfasserin |4 aut | |
| 700 | 1 | |a Itobayashi, Ei |e verfasserin |4 aut | |
| 700 | 1 | |a Shibata, Hiroshi |e verfasserin |4 aut | |
| 700 | 1 | |a Shimada, Noritomo |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Infectious diseases and therapy |d 2012 |g 10(2021), 1 vom: 03. März, Seite 269-280 |w (DE-627)NLM240483693 |x 2193-8229 |7 nnns |
| 773 | 1 | 8 | |g volume:10 |g year:2021 |g number:1 |g day:03 |g month:03 |g pages:269-280 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s40121-020-00364-9 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 10 |j 2021 |e 1 |b 03 |c 03 |h 269-280 | ||