Regulators in the USA have given the green light to Gilead Sciences' Sovaldi, the first drug that has demonstrated safety and efficacy to treat hepatitis C infection without the need for interferon.

The US Food and Drug Administration has approved Sovaldi (sofosbuvir), a nucleotide analogue inhibitor that blocks a specific protein needed by the hep C virus to replicate. The thumbs-up is based on six clinical trials consisting of 1,947 participants who had not previously received treatment for their disease or had not responded to other drugs.

The trials were designed to measure whether the virus was no longer detected in the blood at least 12 weeks after finishing treatment, suggesting a participant’s infection has been cured. The results showed that a regimen containing Sovaldi was effective in treating multiple types of the virus.

Sovaldi becomes the first-ever oral treatment regimen for genotypes 2 or 3, used in combination with ribavirin, although genotype 1, which accounts for 70% of US infections, must be used with both interferon and ribavirin. However, it can be considered for use in patients with genotype 1 infections who are interferon-eligible, while patients with genotype 4 will be treated with the three-drug combination.

Sovaldi is the third drug with breakthrough therapy designation to receive FDA approval and the second backed by the agency in the past two weeks for HCV, following Johnson & Johnson's Olysio (simeprevir).

Costs $1,000 a day

Price-wise, Gilead notes that the wholesaler acquisition cost of a 28-tablet bottle of the once-a-day drug is $28,000. Patients with genotypes 1,2 and 4 will be treated for 12 weeks, while treatment for genotype 3  is 24 weeks and the company noted that it has launched an initiative to provide assistance to patients who are uninsured, underinsured or who need financial assistance to pay for Sovaldi.