Bourlière, M.

Brainard, D.M.

Chessa, L.

Flamm, S.L.

Gallinari, P.

Han, L.

Lawitz, E.

Mcnally, J.

Reddy, K.R. .

Stamm, L.M.

Subramanian, G.M.

CHESSA, LUCHINO

Stamm, L. M.

Brainard, D. M.

Subramanian, G. M.

Flamm, S. L.

Reddy, K. R. .

Archivio istituzionale della ricerca - Università di Cagliari

HepatitisSession/Topic:Poster DiscussionN. Title:Treatment with SOF/VEL is well tolerated and results in high SVR12 in genotype 1-6 HCV infected patients with minimal fibrosis: a retrospective analysis of theASTRAL clinical studiesPD 16Authors:Affiliation:1University Hospital of Cagliari, Italy, 2Texas Liver Institute, University of Texas Health Science Center, SanAntonio, United States, 3Hospital Saint Joseph, Marseille, France, 4Gilead Sciences, Inc., Foster City,5Northwestern University, Chicago, 6University of Pennsylvania, Philadelphia, United StatesAbstract:L. Chessa1, E. Lawitz2, M. Bourlière3, P. Gallinari4, L. Han4, J. Mcnally4, L.M. Stamm4, D.M. Brainard4, G.M.Subramanian4, S.L. Flamm5, K.R. Reddy6Background and Aims: The prioritization of patients with advanced liver disease and cirrhosis fortreatment with DAA based therapy in Italy has resulted in a large population of untreated patientswith minimal or mild fibrosis. Many such patients are already in care, and have been deferredtreatment with DAAs because of mild liver disease (Metavir F0-F2). In Italy, the easing of restrictionsfor DAA treatment regardless of fibrosis status provides an opportunity to treat morepatientsSimple, safe and highly effective regimens are necessary to provide a treatment option inthis population.Methods: This is a retrospective analysis of the safety and efficacy of treatment with SOF/VEL for 12weeks in genotype 1-6 HCV infected patients with minimal or mild fibrosis from the Phase 3 ASTRALstudies. Minimal fibrosis was defined as liver biopsy staged (Metavir F0-2), transient elastography<9.6 kPa, or Fibrotest <0.59. Efficacy was assessed by sustained virologic response 12 weeks aftertreatment (SVR12). Plasma HCV RNA was quantified with the CAP/CTM HCV 2.0 assay with LLOQ=15IU/mL.Results: 887 patients with genotype 1-6 HCV infection and minimal or mild fibrosis were treated withSOF/VEL for 12 weeks; 47% were male, mean age was 49, 67% had non CC genotype, and 20%had failed treatment with an interferon-based regimen. The table below presents the SVR12 bygenotype. SOF/VEL for 12 weeks resulted in SVR12 rates ≥96% across all HCV genotypes in patientswith minimal or mild fibrosis. SOF/VEL was well tolerated with low incidences of severe adverseevents (3.1%), serious adverse events (2.5%) and discontinuations due to adverse events (0.3%).Conclusions: Treatment with SOF/VEL for 12 weeks is well tolerated and results in high SVR12 inHCV infected patients with minimal or mild fibrosis. The availability of simple, pangenotypic, highlyeffective and well-tolerated treatments will enable providers to treat a large number of patients withno fibrosis or minimal fibrosis and thereby impact the prevalence and burden of disease in thispopulation, in line with the eradication plan set up by the Italian Health Ministry.

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Treatment with SOF/VEL is well tolerated and results in high SVR12 in genotype 1-6 HCV infected patients with minimal fibrosis: a retrospective analysis of the ASTRAL clinical studies

Treatment with SOF/VEL is well tolerated and results in high SVR12 in genotype 1-6 HCV infected patients with minimal fibrosis: a retrospective analysis of the ASTRAL clinical studies

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Archivio istituzionale della ricerca - Università di Cagliari