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PLoS One. 2019 Apr 4;14(4):e0214795. doi: 10.1371/journal.pone.0214795. eCollection 2019.

Real-world effectiveness and safety of sofosbuvir/velpatasvir and ledipasvir/sofosbuvir hepatitis C treatment in a single centre in Germany.

Author information

1
Asklepios Klinik St. Georg Haus L, IFI Institut für Interdisziplinäre Medizin, Hamburg, Germany.
2
Amaris Consulting, London, United Kingdom.
3
Gilead Sciences, Inc., Foster City, CA, United States of America.

Abstract

BACKGROUND:

Newer direct-acting antiviral therapies are increasingly becoming the therapy of choice in patients with hepatitis C virus (HCV) infection. Here, we report the safety and effectiveness of sofosbuvir/velpatasvir (SOF/VEL) and ledipasvir/sofosbuvir (LDV/SOF) in real-world cohorts in Germany.

METHODS:

Patients initiated on SOF/VEL 12 weeks or LDV/SOF 8, 12 or 24 weeks regimens in a single German centre were included in this study. Data on treatment outcomes and adverse events (AE) were analysed in patients with available sustained virologic response 12 weeks after cessation of treatment (SVR12) information overall and by subgroups.

RESULTS:

This study included 115 patients who received SOF/VEL from July-2016 to July-2017, and 249 patients who received LDV/SOF from November-2014 to September-2015. Overall, SVR12 was achieved in 99% of patients on SOF/VEL ± ribavirin 12 weeks independent of HCV genotype, treatment history, or cirrhosis status, and in 96% of patients treated with LDV/SOF 8 weeks or LDV/SOF ± ribavirin 12 or 24 weeks. In genotype 1 treatment-naïve, non-cirrhotic patients, ≥99% achieved SVR12 across SOF/VEL and LDV/SOF regimens. Likewise, 100% of genotype 3-cirrhotic patients on SOF/VEL ± ribavirin regimens achieved SVR12. Grade 3/4 AE were reported in 13 (5.2%) patients on LDV/SOF and in 1 (<1%) patient on SOF/VEL.

CONCLUSION:

Overall, SOF/VEL and LDV/SOF achieved high SVR rates in a broad patient population. We showed the effectiveness of SOF/VEL as a pan-genotypic regimen, and regardless of treatment history or cirrhosis status. Use of such therapies improves outcomes and contributes towards the global efforts to eradicate HCV.

Conflict of interest statement

While conducting the research under consideration, the funder (Gilead Sciences, Inc) provided support in the form of salaries for author PB, and provided input for the following: design of data analysis, data interpretation, and manuscript review. The funder did not have any additional role in data collection, data analysis, or decision to publish. Amaris Consulting provided support in the form of data analysis and manuscript preparation. Competing Interests: P.B.: Has been a paid speaker or adviser for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen Pharmaceuticals, Merck Sharpe and Dohme and Roche. He has received research grants from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen Pharmaceuticals, Merck Sharpe & Dohme and Roche. K.W.: Consults, advises, and received grants and lecture fees from Bristol‐Myers Squibb. He consults, advises, and received lecture fees from AbbVie, Gilead, and Janssen. He received lecture fees from Roche. He received grants from Novartis. A.S.: Board Membership: MSD, Böhringer Ingelheim; Speaking and Teaching: Janssen, MSD, Gilead, AbbVie, Böhringer Ingelheim. P.K.A.: Employee of Amaris Consulting. R.S.: Employee of Amaris Consulting. J.L.: Employee of Gilead Sciences, Inc. J.T.: Employee of Gilead Sciences, Inc. J.P.: Grant/Research Support: BMS, Novartis, Roche and Consultant/Advisor: Abbott, AbbVie, BMS, Boehringer, Gilead, GSK, Kedrion, Janssen, Merck, MSD, Novartis, Roche and Sponsored lectures: Abbott, BMS, Boehringer, Gilead, Kedrion, Janssen, Merck, MSD, Novartis, Roche. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

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