Hepatitis C: Experimental Anti-Viral Combo Helps Tough Cases

Patients with advanced chronic kidney disease (CKD) who also have chronic hepatitis C virus genotypes1 showed a sustained response to a new combination therapy, grazoprevir/elbasvir (Merck).

The significance of the results is that the drug combo appears to reach a population with virtually no options.

"This is an untouched population, " said Eliav Barr, MD, vice president of the infectious diseases project for Merc, commenting on the study at a news briefing this morning at the 2015 International Liver Congress. Data from a related study are due to be presented today.

Barr said he was particularly heartened by the results in the chronic kidney disease group because, he said, often physicians will be reluctact to even try to treat these patients.

The results of the phase 2/3 trial were reported April 23 in a poster session of the meeting.

The antiviral combo regimen is the first all-oral ribavirin-free treatment for these patients. It worked for both those who had never been treated for their conditions and those who tried other drugs and they did not work.

C-SURFER stands for safety and efficacy of grazoprevir plus elbasvir in participants with chronic hepatits C and chronic kidney disease is due to be completed in September, 2015.

Researchers looked at group of 111 patients who got grazoprevir plus elbasvir once a day for 12 weeks. A second "deferred treatment" group got a placebo for 12 weeks then, had a 4-week followup period, then also got the drug-combo for 12 weeks.

Of those 122 patients, 83% were treatment naive, 36% had diabetes, 18% had stage 4 CKD, 82% had stage 5 CKD (the most serious) 75% were on dialysis, and nearly half (45%) were African American.

A full 99% of patients getting the drugs showed a significant viral response, said Howard Monsour, MD, chief of hepatology at Houston Methodists Hospital in Houston, TX. in reporting the results yesterday.

Grazoprevir is a protease inhibitor; elbasvir is a replication complex inhibitor. Merck is testing the drug under a US Food and Drug Administration breakthrough therapy designation.

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