On Friday, the U.S. FDA approved Gilead Sciences' Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection.
The daily, all-oral treatment is the first pill approved to treat certain types of hepatitis C infection without the need for the injected drug interferon, which causes flu-like symptoms.
The FDA announcement noted, "Sovaldi’s effectiveness was evaluated in six clinical trials....The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment, suggesting a participant’s HCV infection has been cured."
The CDC reports that about 3.2 million Americans are infected with HCV. Sovaldi's efficacy has been established in multiple types of hepatitis C infection (genotypes 1, 2, 3 or 4) as well as in patients with liver cancer awaiting liver transplantation and those with HCV/HIV-1 co-infection.
According to TheStreet.com, which dubs the Sovaldi launch "Gilead's best and fastest drug launch in history," investors believe first-year Sovaldi sales will total $2.6 billion - a feat that has never previously been accomplished.
This is largely because doctors are expected to adopt it quickly and have been waiting for the Sovaldi approval to treat many of their Hep C patients.
The approval is not without controversy, which largely surrounds the treatment's pricetag.
Gilead reports that most patients will be treated with the $7,000-a-week drug for 12 weeks, resulting in a total price of $84,000.
Dr. Jennifer Cohn, medical director, MSF Access Campaign (Doctors Without Borders) points out the main concern voiced by critics: “This drug is of public health importance but it won’t do much good if it’s unaffordable for the more than one hundred million people with hepatitis C in developing countries.... Using patents to block affordable versions of sofosbuvir and pricing this drug out of reach of the most vulnerable groups who need it most is simply putting profits before people’s lives.”