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'Game changing' hepatitis C pill approved

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A "game changing" new drug with an unprecedented 95% cure rate against the hepatitis C virus was approved by the U.S. Food and Drug Administration (FDA) on December 6.

"The future is looking very bright for people with hepatitis C," said Daniel Raymond, a consumer advocate and Policy Director at the Harm Reduction Coalition.

The FDA's approval "represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

The FDA approval of the new drug called Sovaldi (sofosbuvir) represents a major medical advance. However Raymond cautioned that hurdles remain for consumers, including how to pay for the new medicine.

Hepatitis C is an infectious blood-borne virus that attacks the liver. When left untreated, the virus can lead to cirrhosis, liver failure, and death. In the U.S., 3.2 million are infected, many of whom are still undiagnosed.

About 3% of the world's population (150 million people) are infected. Many people contracted the virus before 1992 when routine testing began.

Manufactured by Gilead Sciences, Sovaldi was approved as one ingredient of a multi-drug "cocktail."

For people with strains of the virus called Type 2 and Type 3, Sovaldi should be combined with an older medicine called ribavirin. This is the first all-oral cocktail for these strains.

For people with Type 1—the most common in the U.S. and the most difficult to treat—Sovaldi should be combined with ribavirin plus an injectable medicine called interferon.

"Sovaldi offers a new option, especially for people with Types 2 and 3," said Raymond. "For those with Type 1, Sovaldi shortens the duration needed for interferon."

A major problem with interferon is depression, which for some can be severe and debilitating.

For this reason, most doctors are unlikely to prescribe any regimen that includes interferon, according to a recent survey. Instead, doctors may wait for better options for people with Type 1.

The $84,000 cure

Interferon aside, Gilead has come under fire about the proposed price tag of Sovaldi. The company recently announced it will charge $84,000 for a 12-week course of treatment and $168,000 for a 24-week course intended for Type 1.

"This is an expensive cure," said Raymond.

For people with Type 1 who cannot tolerate interferon, the issue of cost may be further compounded.

Previous research showed that combining Gilead's Sovaldi (sofosbuvir) with Janssen's Olysio (simeprevir) resulted in an impressive cure rate of up to 100% without interferon.

Olysio was approved last month by the FDA for use with interferon. Janssen (a subsidiary of Johnson & Johnson) has set the price of Olysio at roughly $66,000 for a standard 12-week course.

"The days of injectable interferon have gone by the wayside," said Raymond, "and there's a good case for combining the Gilead drug with the Janssen drug."

While this combination skirts the problems of interferon, it further raises the issues of cost.

Some health insurance companies may not fully cover the cost either drug alone—let alone two separate drugs used "off label," noted Raymond.

Still, he's optimistic that newer drug cocktails for hepatitis C ultimately will prove safer and more cost-effective than older, interferon-based regimens.

"We hope that all the pharmaceutical companies involved play nice together," said Raymond. "These companies should prioritize patients first and profits second."

Several pharmaceutical companies currently are conducting clinical trials of various combinations. Furthest along is the company Abbvie, which is expected to submit its hepatitis C combination to the FDA in early 2014.

For more about experimental hepatitis C medicine, see Positively Aware Hepatitis C Drug Guide.

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