Egypt’s leading drug manufacturer Pharco Pharmaceuticals, Inc. announced advanced results from its Phase III clinical trial of the combination of ravidasvir with sofosbuvir for the treatment of patients with genotype-4 chronic hepatitis C virus, the largest study of its kind globally.

wpid-pharmaceutical-industry-640x360.jpgThe oral, late-breaker presentation entitled: “High Virologic Response Rate in Egyptian HCV-Genotype 4 Patients Treated with Ravidasvir (PPI-668) and Sofosbuvir: Results of a Large Multicenter Phase 3 Registrational Trial”will be presented by the lead Principal Investigator, Gamal Esmat, M.D. at the 66th Meeting of the American Association for the Study of Liver Diseases conference in San Francisco on November 16th 2015.

Results from the Phase III trial in 300 patients showed that combining ravidasvir 200 mg and sofosbuvir 400 mg once daily for 12 weeks resulted in SVR12 (Sustained Virologic Response at 12 weeks post-treatment) rates of 98% overall (255/261 patients). For non-cirrhotic patients, the per-protocol results to date are 100% SVR12 (163/163 patients).
“I am honored that the presentation was accepted as one of only 6 oral late-breaker presentations,” said Professor Esmat.

“The study indicates that we may be able to treat even compensated cirrhotic patients with a high SVR12 rate when we extend therapy to 16 weeks. No relapses have occurred to date in difficult to treat interferon-experienced cirrhotic patients treated for 16 weeks. High SVR12 rates were achieved when the combination was administered once daily for 3 months in non-cirrhotics, and for 4 months with ribavirin in cirrhotics,” he elaborated.

Professor Imam Waked, M.D. commented, “This study suggests that we don’t need ribavirin when using ravidasvir and sofosbuvir for genotype 4 non-cirrhotics, even if the patient previously failed on Interferon.”

“The study treatment was generally well tolerated and the once daily dosing encouraged patients’ adherence to therapy; in addition, a high response rate was evident in all treatment groups,” said Professor Maissa El Raziky, M.D., one of the three principal investigators.

In August 2014, Pharco Corporation licensed ravidasvir hydrochloride in Egypt from Presidio Pharmaceuticals Inc., a US clinical stage pharmaceutical company. The phase III study obtained all the necessary approvals prior to its official start in January 2015.

“At Presidio we have been pleased to work with the Pharco team and Egyptian clinical experts as they investigate the combination of ravidasvir, Presidio’s HCV NS5A inhibitor, with sofosbuvir in a large study population of genotype-4 Egyptian patients,” said Nathaniel A. Brown, M.D., Chief Medical Advisor at Presidio.

Dr. SherineHelmy, President of Pharco Corporation commented, “The study is the first of a comprehensive scientific program that we are committed to deliver to our country. We have one purpose: effectively eradicate HCV in Egypt at a highly affordable cost; ravidasvir combined with sofosbuvir is a promising once daily oral treatment that is well-tolerated and shows high sustained virologic response rates in Egyptian HCV Genotype 4 patients.”


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