New agents offer promise for patients with hepatitis C, real-world study indicates

Telaprevir (Incivek, Vertex) and boceprevir (Victrelis, Merck) may offer a more promising future to patients with the hepatitis C genotype 1 infection when combined with the previous regimen of peginterferon alfa and ribavirin, according to emerging research data reported in Atlantic Information Services' SpecialtyPharmacy News.

While the current standard of care for patients with chronic hepatitis C infection is peginterferon alfa and ribavirin taken for 48 weeks, only about 45% of patients respond to this therapy.

FDA approved telaprevir and boceprevir for use with the interferon therapy in May 2011. The new drugs work by binding to the virus and preventing it from multiplying. Studies have demonstrated that a triple-therapy regimen using one of the new agents can increase a patient's chance of clearing the virus to more than 75%, as well as shorten the duration of treatment to 24 weeks.

Steve Burman, CEO of Burman's Medical Supplies and Specialty Pharmacy and president of Burman's Pharmacy, said that the company has been tracking approximately 700 patients who began treatment with telaprevir and boceprevir when the drugs were approved.

"We knew there were going to be new agents coming out in May or June of 2011, and we knew it was going to be complicated. We try to focus in areas that are difficult because we can make a bigger difference there and create some value," Burman explained. His company has a software program that it developed to help track patient data.

With telaprevir costing around $17,000 a month and boceprevir coming in around $4,000 a month, therapy costs have nearly doubled, Burman said. There are 600,000 patients waiting for treatment, Burman added. If 50% of them were eligible for response- guided therapy, it could save the health system over $5 billion by cutting the 6 months of interferon therapy, which costs about $18,000 per patient, he explained.

PROMISING DATA

For patients, the data provides promise. Among patients treated with telaprevir, the data showed that 50% of the patients were naïve to hepatitis treatment, the other 50% were divided equally between patients who relapsed, patients who had a partial response, and patients who demonstrated no response to previous therapy, Burman said.

Telaprevir therapy was discontinued due to side effects in 14% of the patients. Although rash was common with telaprevir, only a small percentage of patients needed to discontinue therapy due to rash. Another 14% of the patients were discontinued for no response to therapy.

Among the patients taking boceprevir, 60% were naïve, 20% were prior relapsers, and 20% were partial responders to previous therapy. Anemia was one of the side effects, but only 13% of patients discontinued due to all side effects, Burman said.

"When you consider that previous therapy of peg-riba had a discontinue rate of 12% due to side effects, it appears that both Incivek and Victrelis are both well tolerated," Burman said. "We are in the process of comparing therapies, Incivek versus Victrelis, by analyzing 4-,8-,and 12-week viral response."

So far, these results have been similar to what the literature shows, Burman said. However, he's looking forward to gathering the data on the first of the response-guided therapy group. He said in a group of 77 patients treated with telaprevir, 75% of the naïve patients and 91% of prior relapsers achieved early viral response and 66% of the naïve population treated with boceprevir achieved early viral response, making them eligible for the shortened therapy.

"The first group of patients hit their 24-week mark in January, so we have to wait 6 months to retest them," Burman said. "If they're clear, they're considered cured. That will be the true test."