Hepatitis C Drug, Harvoni, Approved By FDA

A new drug called Harvoni, which stands to change the way hepatitis C is treated, has just won approval for use by the Food and Drug Administration, the New York Times reported Friday. The drug is the first single-pill treatment for hepatitis C on the drug market, and has been proven to eliminate the virus in over 90 percent of patients in clinical trials.

Experts say Harvoni is hopeful for hepatitis C patients because it's much simpler to take than other drugs and it can also be less expensive. A 12-week course of Harvoni will sell for $94,500 wholesale; however, many patients may only see an eight-week treatment of the drug, which would lower its price to $63,000. In comparison, the current leading hepatitis C treatment, a drug called Sovaldi costs $84,000 for a 12-week course, and must be used with other drugs, which increases the total price of the treatment.

“We’re talking about a much lower cost to Medicaid for a substantial number of people, and to me that’s a game changer,” said Ryan Clary, executive director of the National Viral Hepatitis Roundtable.

Providing treatment for hepatitis C has been challenging since insurance companies and Medicaid programs have set restrictions on the use of Sovaldi. The drug is to be prescribed only to the most seriously ill patients, usually those with advanced liver disease. Sovaldi requires a co-prescription of other hepatitis C drugs such as the intravenous treatment alpha interferon or the oral treatment Ribavirin; however, these drugs are known for several side effects including flu-like symptoms and depression. Several issues with Sovaldi have led doctors to recommend patients wait for Harvoni to be available before proceeding with treatment.

Harvoni, which has been approved for treatment of the main subtype of hepatitis C, called genotype 1, can be used at any stage. Overall, early treatment of hepatitis C is recommended. “The sooner you cure them, the more likely you are to have better long-term outcomes for these patients,” John F. Milligan, president and chief operating officer of Gilead Sciences, the company that developed both Sovaldi and Harvoni, said at the Morgan Stanley health care conference last month.

Gilead plans to allow for generic manufacturing of Sovaldi and Harvoni in order to provide low-cost version of the drugs for 90 disadvantaged countries.