NICE guidance backs Gilead's Harvoni for genotype 1, 4 hepatitis C, but not genotype 3

The National Institute for Health and Care Excellence issued draft guidance Tuesday recommending NHS reimbursement of Gilead Sciences' Harvoni (ledipasvir/sofosbuvir) as a treatment option for certain adults with genotype 1 or 4 chronic hepatitis C. Carole Longson, director of NICE's Centre for Health Technology Evaluation, said the therapy "offers the possibility of a shortened course of treatment – in some cases as little as eight weeks – without the need for combination therapy with interferon."

Longson added "this could make it more likely that people will seek treatment for their condition. In turn this could have important benefits, not just for people with chronic hepatitis, but also in reducing transmission of the virus to people without the infection." NICE noted that Harvoni, which was approved by the European Commission in November last year, costs 38,979.99 pounds ($59,915) for a 12-week course of treatment.

Although the drug is also approved in Europe for the treatment of genotype 3, NICE said that based on evidence the use of Harvoni in these patients "could not be considered a cost-effective use of NHS resources." According to the agency, genotype 1 disease represents 46 percent of hepatitis C cases in England, genotype 3 makes up 43 percent and genotype 4 accounts for around 4 percent of cases.

NICE recently issued final guidance recommending Gilead's Sovaldi (sofosbuvir) for patients with hepatitis C, although the agency has allowed NHS England to postpone implementation for four months, until the end of July instead of the beginning of April.

For related analysis, see ViewPoints: Europe to provide Gilead with 'durable' hepatitis C revenues?

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