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High Response Rate in HCV-Genotype 4 Patients Treated With Ravidasvir and Sofosbuvir
Gamal Esmat1; Maissa El Raziky2; Asmaa Gomaa3; Tamer Elbaz4; Mahmoud Abouelkhair2; Alyaa Sabry3; Hadeel Gamal Eldeen4; Mohammed Karim2; Mohammed Abdel-Hamid5; Ola Nada5; Sherine Helmy6; Hanaa Abdel-Maguid6; Richard Colonno7; Nathaniel Brown7; Eric Ruby7; Pamela Vig7;Imam Waked3
1Cairo Univ, Cairo, Egypt;2Cairo Fatemic Hosp, Cairo, Egypt;3Natl Liver Inst, Shebeen El Kom, Egypt;4Kasr Alaini Viral Hepatitis Cntr, Cairo, Egypt;5MyLab Lab, Cairo, Egypt;6European Egyptian Pharmaceutical Industries, Alexandria, Egypt;7Presidio Pharmaceuticals, San Francisco, CA, USA
Egypt has the highest prevalence of hepatitis C infection in the world, of which 90% is due to HCV genotype-4 (gt-4). Increasing HCV-related morbidity in Egypt presents an urgent need for highly curative, safe and affordable therapies. We report results from a Phase 3 registrational trial in Egyptian HCV gt-4 patients, assessing the combination of ravidasvir (RDV), a pan-genotypic HCV NS5A inhibitor, and sofosbuvir (SOF), a nucleotide HCV NS5B polymerase inhibitor, with or without ribavirin (RBV).
Key inclusion criteria were age 18-65 yr, HCV gt-4 infection, serum HCV RNA >4 log10 IU/mL, and absence of decompensated cirrhosis or other causes of liver disease. Patients were enrolled into 3 groups: treatment-naïve non-cirrhotic and cirrhotic, by Fibroscan & FIB-4 score (Group 1); interferon (IFN)-experienced non-cirrhotic (Group 2); and IFN-experienced cirrhotic (Group 3). Groups 1 and 2 were treated with RDV 200 mg QD + SOF 400 mg QD for 12 wk, randomized 1:1 to additional RBV (weight-based) or no RBV. Group 3 patients all received RDV+SOF+RBV and were randomized 1:1 to 12 wk vs.16 wk of treatment. The primary endpoint is sustained virologic response (SVR), defined as serum HCV RNA below the lower limit of detection (LLD <12 IU/mL by the Abbott Real-Time™ PCR assay) at 12 wk post-treatment (SVR12).
This study is fully enrolled with 300 patients (150 in Group 1, 80 in Group 2, and 70 in Group 3); 284 patients had completed treatment at the time of this abstract. Study treatment has been generally well tolerated, with one serious adverse event possibly attributed to study drug (transient episode of symptomatic bradycardia). The most common adverse events are headache and fatigue. HCV RNA decreased by ~6 logs in all groups by Wk 1, with 94% of patients HCV RNA undetectable by Wk 4. Of the 265 patients who have reached 4 wk post-treatment, 262 (99%) had RNA
To our knowledge, this is the largest IFN-free clinical trial in HCV gt-4 patients. Treatment with RDV+SOF±RBV has been well-tolerated and shows high sustained response rates in a large population of Egyptian patients, regardless of previous treatment status or underlying cirrhosis.