Two-drug Therapy for HCV Patients Matches SVR Results Shown in Clinical Trials

A two-drug combination hepatitis C therapy showed efficacy and safety in treating real-world patients in Korea — results that were consistent with clinical studies in the country, according to findings presented at The Liver Week 2017 in Incheon, South Korea.

BMS Pharmaceutical Korea, an affiliate of New York-based Bristol-Myers Squibb, reported that a dual-drug regimen of the company’s daclatasvir (Daklinza) and asunaprevir (Sunvepra) produced a sustained virologic response (SVR) rate of 95.2% in 12 weeks. That was similar to the results reported for the therapy in Korean clinical trials.

The SVR rate was slightly higher, at 95.8%, among patients without nonstructural protein 5A (NS5A) resistance mutation, according to a report from the June 22-24 conference.

The study involved 591 patients with genotype 1b hepatitis C. They were treated at eight Korean Catholic Medical Center (CMC) hospitals, according to the report.

The successful test of Daklinza-Sunvepra in a real-life environment may add support for the combination therapy, suggested Jang Jung-won, a professor at the Department of Internal Medicine at Seoul St. Mary's Hospital, one of the participating facilities.

"Proven effectiveness and security in non-clinical, actual prescription experience is a fundamental basis for physicians and patients choosing therapeutic agents," Jung-won said.

Daklinza-Sunvepra is Korea’s first direct-acting antiviral (DAA) drug, Lee Seung-hoon, managing director of BMS Pharmaceutical Division, Korea, said.

DAAs are rapidly replacing interferon-based treatments in Asia and beyond. The pills are gaining converts because they require shorter treatment times, improve cure rates and produce fewer side effects. However, high prices have kept DAAs out of the reach of many patients worldwide, studies have shown.

The Daklinza-Sunvepra combination has received approvals elsewhere in Asia. In April, the China Food and Drug Administration (CFDA) authorized the therapy for people with genotype 1b HCV in that nation’s first all-oral, interferon- and ribavirin-free HCV treatment regimen.

In July 2014 the Japanese Ministry of Health, Labor and Welfare (MHLW) approved the dual therapy. The move provides a cure for many patients in that country who have no treatment options, Bristol-Myers Squibb said.

Korea has a less than 1% prevalence of HCV infection, according to “Current status of hepatitis C virus infection and countermeasures in South Korea,” which was published April 13 in Epidemiology and Health. But one estimate from 2016 found that 230,000 to 250,000 HCV-positive individuals were living in the country without undergoing any form of treatment.

HCV infection due to intravenous drug abuse is still low in Korea. And blood transfusions are not likely to lead to hepatitis C in the future because the country has adopted mandatory screening. However, recent outbreaks of the liver-attacking virus in medical facilities have become a public health problem, according to the status report.

A report of the findings shared at the conference was published online in The Korea Biomedical Review:

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