Sofosbuvir plus velpatasvir for 8 weeks in patients with acute hepatitis C : The HepNet acute HCV-V study
© 2022 The Author(s)..
Background & Aims: EASL guidelines recommend 8 weeks of treatment with sofosbuvir plus velpatasvir (SOF/VEL) for the treatment of acute or recently acquired HCV infection, but only 6- and 12-week data are available. Therefore, the aim of this study was to evaluate the safety and efficacy of a shortened 8-week SOF/VEL treatment for acute HCV monoinfection.
Methods: In this investigator-initiated, prospective, multicentre, single-arm study, we recruited 20 adult patients with acute HCV monoinfection from nine centers in Germany. Patients received SOF/VEL (400/100 mg) as a fixed-dose combination tablet once daily for 8 weeks. The primary efficacy endpoint was the proportion of patients with sustained virological response 12 weeks after the end of treatment (SVR12).
Results: The median HCV RNA viral load at baseline was 104,307 IU/ml; the distribution of HCV genotypes was as follows: GT1a/1b/2/3/4: n = 12/1/1/3/3. Thirteen (65%) of the 20 patients were taking medication for HIV pre-exposure prophylaxis. SVR12 was achieved in all patients who complied with the study protocol (n = 18/18 [100%], per protocol analysis), but the primary endpoint was not met in the intention-to-treat analysis (n = 18/20 [90%]) because two patients were lost to follow-up. One serious adverse event (unrelated to study drug) occurred during 12 weeks of post-treatment follow-up.
Conclusions: The 8-week treatment with SOF/VEL was well tolerated and highly effective in all adherent patients with acute HCV monoinfection. Early treatment of hepatitis C might effectively prevent the spread of HCV in high-risk groups.
Clinical Trial Number: NCT03818308.
Impact and implications: The HepNet acute HCV-V study (NCT03818308), an investigator-initiated, single-arm, multicenter pilot study, demonstrates the efficacy and safety of 8 weeks of daily treatment with the fixed-dose combination sofosbuvir/velpatasvir (400/100 mg) in patients with acute hepatitis C virus (HCV) infection. All patients who completed therapy and were followed-up achieved sustained virologic response. Thus, early treatment with SOF/VEL which might effectively prevent the spread of HCV in high-risk groups can be recommended for patients with acute HCV monoinfection.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:5 |
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| Enthalten in: |
JHEP reports : innovation in hepatology - 5(2023), 3 vom: 23. März, Seite 100650 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Maasoumy, Benjamin [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Revised 01.03.2023 published: Electronic-eCollection ClinicalTrials.gov: NCT03818308 Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1016/j.jhepr.2022.100650 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM353581909 |
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| 100 | 1 | |a Maasoumy, Benjamin |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Sofosbuvir plus velpatasvir for 8 weeks in patients with acute hepatitis C |b The HepNet acute HCV-V study |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
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| 500 | |a Date Revised 01.03.2023 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a ClinicalTrials.gov: NCT03818308 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2022 The Author(s). | ||
| 520 | |a Background & Aims: EASL guidelines recommend 8 weeks of treatment with sofosbuvir plus velpatasvir (SOF/VEL) for the treatment of acute or recently acquired HCV infection, but only 6- and 12-week data are available. Therefore, the aim of this study was to evaluate the safety and efficacy of a shortened 8-week SOF/VEL treatment for acute HCV monoinfection | ||
| 520 | |a Methods: In this investigator-initiated, prospective, multicentre, single-arm study, we recruited 20 adult patients with acute HCV monoinfection from nine centers in Germany. Patients received SOF/VEL (400/100 mg) as a fixed-dose combination tablet once daily for 8 weeks. The primary efficacy endpoint was the proportion of patients with sustained virological response 12 weeks after the end of treatment (SVR12) | ||
| 520 | |a Results: The median HCV RNA viral load at baseline was 104,307 IU/ml; the distribution of HCV genotypes was as follows: GT1a/1b/2/3/4: n = 12/1/1/3/3. Thirteen (65%) of the 20 patients were taking medication for HIV pre-exposure prophylaxis. SVR12 was achieved in all patients who complied with the study protocol (n = 18/18 [100%], per protocol analysis), but the primary endpoint was not met in the intention-to-treat analysis (n = 18/20 [90%]) because two patients were lost to follow-up. One serious adverse event (unrelated to study drug) occurred during 12 weeks of post-treatment follow-up | ||
| 520 | |a Conclusions: The 8-week treatment with SOF/VEL was well tolerated and highly effective in all adherent patients with acute HCV monoinfection. Early treatment of hepatitis C might effectively prevent the spread of HCV in high-risk groups | ||
| 520 | |a Clinical Trial Number: NCT03818308 | ||
| 520 | |a Impact and implications: The HepNet acute HCV-V study (NCT03818308), an investigator-initiated, single-arm, multicenter pilot study, demonstrates the efficacy and safety of 8 weeks of daily treatment with the fixed-dose combination sofosbuvir/velpatasvir (400/100 mg) in patients with acute hepatitis C virus (HCV) infection. All patients who completed therapy and were followed-up achieved sustained virologic response. Thus, early treatment with SOF/VEL which might effectively prevent the spread of HCV in high-risk groups can be recommended for patients with acute HCV monoinfection | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a ALT, alanine aminotransferase | |
| 650 | 4 | |a HCV, hepatitis C virus | |
| 650 | 4 | |a ITT, intention-to-treat | |
| 650 | 4 | |a LLOQ, lower limit of quantification | |
| 650 | 4 | |a PP, per protocol | |
| 650 | 4 | |a SVR, sustained virologic response | |
| 650 | 4 | |a ULN, upper limit of normal | |
| 650 | 4 | |a acute HCV infection | |
| 650 | 4 | |a direct-acting antivirals | |
| 650 | 4 | |a hepatitis C elimination | |
| 650 | 4 | |a recently acquired infection | |
| 700 | 1 | |a Ingiliz, Patrick |e verfasserin |4 aut | |
| 700 | 1 | |a Spinner, Christoph D |e verfasserin |4 aut | |
| 700 | 1 | |a Cordes, Christiane |e verfasserin |4 aut | |
| 700 | 1 | |a Stellbrink, Hans-Jürgen |e verfasserin |4 aut | |
| 700 | 1 | |a Schulze Zur Wiesch, Julian |e verfasserin |4 aut | |
| 700 | 1 | |a Schneeweiß, Stephan M |e verfasserin |4 aut | |
| 700 | 1 | |a Deterding, Katja |e verfasserin |4 aut | |
| 700 | 1 | |a Müller, Tobias |e verfasserin |4 aut | |
| 700 | 1 | |a Kahlhöfer, Julia |e verfasserin |4 aut | |
| 700 | 1 | |a Dörge, Petra |e verfasserin |4 aut | |
| 700 | 1 | |a von Karpowitz, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Manns, Michael P |e verfasserin |4 aut | |
| 700 | 1 | |a Wedemeyer, Heiner |e verfasserin |4 aut | |
| 700 | 1 | |a Cornberg, Markus |e verfasserin |4 aut | |
| 700 | 0 | |a HepNet Acute HCV-V Study Group |e verfasserin |4 aut | |
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