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References
EPCLUSA® is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults1
למידע נוסף על בטיחות ויעילות, אנא עיין בעלון לרופא של אפקלוזה המפורסם במאגר התרופות של משרד הבריאות.
Footnotes:
- In a large-cohort international real-world study, all patients with unknown genotype (n = 42), unknown fibrosis score (n = 82) and unknown treatment history (n = 33) were cured with EPCLUSA® for 12 weeks.2
EASL defines cure as SVR, i.e. undetectable HCV RNA after treatment completion. 6 - EPCLUSA® offers an RBV-free STR option for the majority of HCV patients, excluding those with decompensated cirrhosis. For further information on restrictions please refer to the Prescribing Information. The addition of RBV is recommended for the treatment of patients with decompensated cirrhosis and may be considered for the treatment of HCV GT3 patients with compensated cirrhosis 1
- In a Phase 2 study in patients with chronic HCV and CPT-C cirrhosis, EPCLUSA® + RBV for 12 weeks led to a 78% (25/32) SVR12 rate. Treatment was well tolerated, with observed AEs consistent with expectations for a patient population with advanced liver disease. 5
References:
- EPCLUSA® Israeli prescribing information, April 2020.
- Mangia A et al. Liver Int 2020;40:1841–1852
- Lawitz E et al. Poster THU-273 presented at the International Liver Congress 2017, Amsterdam, The Netherlands. Available from: https://www.natap.org/2017/EASL/EASL_07.htm. Accessed September 2020.
- University of Liverpool. HEP Drug Interactions Checker. Available from: https://www.hep-druginteractions.org/checker. Accessed October 2020.
- Flamm S et al. Poster THU-138 presented at the International Liver Congress 2019, Vienna, Austria.
- European Association for the Study of the Liver (EASL). J Hepatol 2020;73(5):1170–1218.
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals and patients are asked to report any suspected adverse reactions to the MoH using the link https://sideeffects.health.gov.il/
Adverse reactions may also be reported directly to the manufacturer of the suspected product. Adverse reactions related to Gilead products may be reported directly to Gilead via details below.
DrugSafety.Israel@gilead.com.
IL-HCV-2021-01-0009
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