The US Food and Drug Administration (USFDA) approved the first fixed-dose combination (FDC) direct-acting antiviral (DAA) used to treat hepatitis C. The combination of sofosbuvir/ledipasvir (SOF/LDV) represents a more powerful and effective all-oral treatment for hepatitis C (HCV), particularly for people with genotype 1 HCV. The approval of this FDC is a welcome step for people with genotype 1 disease, given it can be used without ribavirin, which causes many side-effects, meaning it is potentially better tolerated by people.
While there is some suggestion that SOF/LDV is effective for genotype 3, Gilead is not planning to do larger phase III studies for additional genotypes; we would encourage Gilead to reconsider, given the need for effective treatments for all genotypes.
While pricing for SOF/LDV has not been released, with sofosbuvir currently priced at $84,000 per treatment in the United States, it’s thought this combination could be priced as much as $100,000 or more; far beyond the reach of most people with the disease, in either developed or developing countries.
Both sofosbuvir and ledipasvir, as well as the combination, were recently included in a voluntary licence agreement offered by pharmaceutical company Gilead, with licences signed by seven Indian generic drug and active pharmaceutical ingredient manufacturers to produce generic versions of both drugs, as well as the combination. However, this licence fell far short of improving access for millions of patients, since the agreement excluded many key and high burden countries, especially middle-income countries. Combined with other restrictions included in the agreement, it means millions of people could be left without affordable access to this life-saving combination.
Médecins Sans Frontières (MSF) responds to the approval of sofosbuvir/ledipasvir with the below quote:
“The FDA’s approval of sofosbuvir/ledipasvir is a welcome one, given the effectiveness of this first all-oral fixed dose combination for hepatitis C. While this approval is welcome news for people with genotype 1 hepatitis C, companies must do more to develop and test combinations for other genotypes as well.
“With rumours of price for this combination thought to be as high as the eye-watering $100,000 mark, countries – especially those excluded from Gilead’s voluntary licence – should be using all the measures at their disposal to encourage generic competition. While Gilead should immediately expand the geographic reach of its voluntary license to include millions of patients being left behind in middle-income countries, all countries should demand affordable access and not accept unaffordable prices for the public and private sector.”
- Dr Jennifer Cohn, Medical Director, Médecins Sans Frontières Access Campaign.
"MSF welcomes approval of new #HepC treatment, urges @Gileadsciences to expand affordable access to more countries"