On December 6th, 2013 the FDA announced the approval of Gilead’s once-a-day pill Sofosbuvir, marketed as Sovaldi. The approval comes shortly after an FDA advisory committee awarded Gilead breakthrough therapy status for the once-a-day pill Sofosbuvir at the end of October 2013 (see previous Sofosbuvir article). The FDA committee also unanimously recommended the approval of Sofosbuvir in conjunction with Ribavirin and Pegylated Interferon for treatment naïve patients with chronic hepatitis C who have the specific genotype 1 and genotype 4 infections.
The once-a-day pill Sofosbuvir is designed to treat the main forms of hepatitis C that affect U.S. patients. This highly anticipated approval comes as the FDA recommends people born between 1945 and 1965 get tested for hepatitis C. Baby boomers are five times more at risk to have the disease than other age groups – even more so than younger people who share needles or have unprotected sex with hepatitis C infected individuals.
Sofosbuvir is the first in a new class of nucleotide polymerase inhibitors that doesn’t require interferon injections. This once-a-day pill pushes the cure rate much higher than before.
As a nucleotide analogue, Sofosbuvir has demonstrated safe and formidable effects in four Phase 3 trials coined FISSION, FUSION, NEUTRINO and POSITRON. The POSITRON study specifically showcased the benefits of Sofosbuvir in patients who were unable or unwilling to take adjunctive interferon. Patients with genotypes 1 and 4 hepatitis C infections will still need to be treated with peg interferon, but the concomitant use of Sofosbuvir makes a shorter treatment time available, specifically 12 weeks duration, creating a lesser probability of adverse effects. Patients with the hepatitis genotype 3 infections displayed success in the FUSION trial after a full 16 weeks of treatment with Sofosbuvir. While a 12 week course of treatment did reveal positive data, the percentage of genotype 3 patients finding relief grew substantially with the extended course of treatment.
Gilead has announced that it would sell the Sovaldi 12-week treatment for $84,000. Patients with a less common form of hepatitis C might require a 24 week treatment of the drug, upping the cost to $168,000. Existing hepatitis C drugs on the market average between $25,000 and $50,000 per treatment.
Next year Gilead plans on filing for FDA approval of a combination pill containing Sofosbuvir and Ledipasvir, another antiviral drug, that could become the first all-oral regimen for the most common form of hepatitis C, long viewed as the holy grail of treatments by drug makers. Similar development efforts are underway from competitors like Abbott Laboratories, Bristol-Myers Squibb Co., Vertex Pharmaceuticals and others.
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