Hepatitis C Treatment Options

San Antonio—In May 2011, the FDA approved 2 direct acting antiviral oral medications that substantially improved sustained virologic response (SVR) in patients with genotype 1 hepatitis C: boceprevir and telaprevir. Still, these agents have to be used in combination with pegylated interferon and ribavirin for 24 to 48 weeks. For genotypes 2 and 3 hepatitis C, the standard of care is pegylated interferon and ribavirin for 24 weeks.

With more than 20 hepatitis C drugs in the pipeline, the preferred regimens could soon change, according to Linda Spooner, PharmD, associate professor of pharmacy practice at the Massachusetts College of Pharmacy and Health Sciences University.

In fact, Dr. Spooner said that many healthcare providers are not treating patients with hepatitis C because they are waiting for the new drugs to be approved. They believe boceprevir and telaprevir have drug interactions and side effects and the new regimens may be simpler, prevent resistance, and have a greater chance of an SVR. When some of the new regimens are introduced, she predicted that boceprevir and telaprevir could “fall by the wayside” and not be used much. Dr. Spooner spoke at the AMCP meeting during a session titled Evolving Treatment Strategies for Hepatitis C. Gilead Sciences, Inc. supported the session with an educational grant.

Approximately 4 million people in the United States have hepatitis C, although most of them are not aware they have the disease or are receiving treatment. Each year, there are approximately 17,000 new cases of hepatitis C, with 85% of the cases becoming chronic. Hepatitis C is the leading cause of chronic liver disease, cirrhosis, liver cancer, and liver transplantation. 

Dr. Spooner said there is a need for new hepatitis C regimens that do not include injections, require fewer pills, need less frequent dosing, and have fewer side effects. Pharmaceutical companies are developing regimens that do not include interferons, which are associated with flu-like symptoms and hematologic, psychiatric, endocrine, dermatologic, neurologic, pulmonary, and ophthalmologic adverse effects. Interferon-free regimens could lead to lower discontinuation rates, lower chances of resistance, and more convenient dosing.

The FDA could soon approve 2 new direct acting antiviral oral medications (sofosbuvir and simeprevir), according to Dr. Spooner. Patients would use sofosbuvir and simeprevir in combination with interferon and ribavirin. They also may be allowed to use an interferon-free regimen of sofosbuvir plus ribavirin.

Two other direct acting antiviral oral medications (daclatasvir and asunaprevir) are in late stage development and would be used together if approved. The FDA may also approve pegylated interferon lambda in the coming months.