Novel combined single dose anti-hepatitis C therapy: a pilot study

Abstract The new anti-hepatitis C virus (HCV) molecules improve treatment regimens and outcomes, but there are drawbacks. New combinations should target the HCV infectious cycle and be effective against all HCV genotypes. We developed the novel formulation Catvira, composed of epigallocatechingallat...

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Autores principales:	Gamal Shiha, Reham Soliman, Mohamed Elbasiony, Noureldien H. E. Darwish, Shaker A. Mousa
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/c125c5d7acf641d7bc44530b72c5414f
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spelling	oai:doaj.org-article:c125c5d7acf641d7bc44530b72c5414f2021-12-02T13:19:29ZNovel combined single dose anti-hepatitis C therapy: a pilot study10.1038/s41598-021-84066-32045-2322https://doaj.org/article/c125c5d7acf641d7bc44530b72c5414f2021-02-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-84066-3https://doaj.org/toc/2045-2322Abstract The new anti-hepatitis C virus (HCV) molecules improve treatment regimens and outcomes, but there are drawbacks. New combinations should target the HCV infectious cycle and be effective against all HCV genotypes. We developed the novel formulation Catvira, composed of epigallocatechingallate (EGCG) + sofosbuvir + ribavirin. Here, we compared Catvira to sofosbuvir + ribavirin tablets in patients with CHC genotype 4 in a randomized open-label efficacy and safety study. Treatment-naïve and treatment-experienced patients (n = 80) were randomly assigned to receive a single daily fixed dose of Catvira or sofosbuvir + ribavirin for 12 or 24 weeks. Both Catvira and sofosbuvir + ribavirin yielded similar outcomes of viral load (p < 0.001). Patients receiving Catvira had a significantly more rapid rate of viral load decline with sustained virologic response (SVR12) achieved by 90% of patients receiving 12 weeks of treatment. Catvira did not impact hemoglobin levels while sofosbuvir + ribavirin showed significant decline in hemoglobin levels after 24 weeks (p < 0.05). In this clinical trial (ClinicalTrials.gov Identifier NCT02483156), we found that Catvira administered daily for 12 or 24 weeks is safe, effective, and well-tolerated in both naïve and treatment-experienced patients with HCV genotype 4.Gamal ShihaReham SolimanMohamed ElbasionyNoureldien H. E. DarwishShaker A. MousaNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-7 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Gamal Shiha Reham Soliman Mohamed Elbasiony Noureldien H. E. Darwish Shaker A. Mousa Novel combined single dose anti-hepatitis C therapy: a pilot study
description	Abstract The new anti-hepatitis C virus (HCV) molecules improve treatment regimens and outcomes, but there are drawbacks. New combinations should target the HCV infectious cycle and be effective against all HCV genotypes. We developed the novel formulation Catvira, composed of epigallocatechingallate (EGCG) + sofosbuvir + ribavirin. Here, we compared Catvira to sofosbuvir + ribavirin tablets in patients with CHC genotype 4 in a randomized open-label efficacy and safety study. Treatment-naïve and treatment-experienced patients (n = 80) were randomly assigned to receive a single daily fixed dose of Catvira or sofosbuvir + ribavirin for 12 or 24 weeks. Both Catvira and sofosbuvir + ribavirin yielded similar outcomes of viral load (p < 0.001). Patients receiving Catvira had a significantly more rapid rate of viral load decline with sustained virologic response (SVR12) achieved by 90% of patients receiving 12 weeks of treatment. Catvira did not impact hemoglobin levels while sofosbuvir + ribavirin showed significant decline in hemoglobin levels after 24 weeks (p < 0.05). In this clinical trial (ClinicalTrials.gov Identifier NCT02483156), we found that Catvira administered daily for 12 or 24 weeks is safe, effective, and well-tolerated in both naïve and treatment-experienced patients with HCV genotype 4.
format	article
author	Gamal Shiha Reham Soliman Mohamed Elbasiony Noureldien H. E. Darwish Shaker A. Mousa
author_facet	Gamal Shiha Reham Soliman Mohamed Elbasiony Noureldien H. E. Darwish Shaker A. Mousa
author_sort	Gamal Shiha
title	Novel combined single dose anti-hepatitis C therapy: a pilot study
title_short	Novel combined single dose anti-hepatitis C therapy: a pilot study
title_full	Novel combined single dose anti-hepatitis C therapy: a pilot study
title_fullStr	Novel combined single dose anti-hepatitis C therapy: a pilot study
title_full_unstemmed	Novel combined single dose anti-hepatitis C therapy: a pilot study
title_sort	novel combined single dose anti-hepatitis c therapy: a pilot study
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/c125c5d7acf641d7bc44530b72c5414f
work_keys_str_mv	AT gamalshiha novelcombinedsingledoseantihepatitisctherapyapilotstudy AT rehamsoliman novelcombinedsingledoseantihepatitisctherapyapilotstudy AT mohamedelbasiony novelcombinedsingledoseantihepatitisctherapyapilotstudy AT noureldienhedarwish novelcombinedsingledoseantihepatitisctherapyapilotstudy AT shakeramousa novelcombinedsingledoseantihepatitisctherapyapilotstudy
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Novel combined single dose anti-hepatitis C therapy: a pilot study

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