NICE Approves Epclusa to Treat More Genotypes of Hepatitis C

NICE Approves Epclusa to Treat More Genotypes of Hepatitis C

The U.K. National Health Service’s (NHS) National Institute for Health and Care Excellence (NICE) recently published a new draft guidance recommending Epclusa (sofosbuvir-velpatasvir), an anti-viral drug that offers patients with chronic hepatitis C infection a new therapeutic option.

The NICE appraisal committee concluded that Epclusa was clinically- and cost-effective, and recommended its regular availability through the NHS. The draft guidance recommends that the decision to give patients the combination treatment should be made by multidisciplinary teams in the operational delivery networks set up by the NHS England.

Epclusa is an oral fixed-dose combination of sofosbuvir, an inhibitor of the viral NS5B polymerase, and velapatasvir, an inhibitor of the viral NS5A replication complex. The drug works by blocking the virus from multiplying and infecting new cells. Previous clinical trials have shown cure rates of 89% and above, for all hepatitis C virus (HCV) genotypes.

Sofosbuvir is currently approved in the U.S. for the treatment of HCV genotypes 1, 2, 3 and 4, with different regimens according to the HCV genotype. Velpatasvir is a novel NS5A inhibitor with potent in vitro anti-HCV activity across all genotypes. The combination therapy is the first once-daily single-tablet regiment with pan-genotypic activity. (Pan-genotypic drugs work against every genotype.)

People with HCV genotype 3 account for 44% of the patient population with chronic hepatitis C. They are treated currently with an older type of anti-viral drug, which can cause unwanted side effects, or “with a daclastavir-based regimen depending on … the stage of liver disease,” NICE reported in a release, adding that Epclusa would be will be another “effective treatment to this group of patients.”

“The decision by the independent NICE appraisal committee to recommend sofosbuvir-velpatasvir is great news. The drug provides considerable health benefits to patients with hepatitis C, in particular, those with genotype 3 who can become very ill, very quickly,” Carole Longson, director of the NICE Centre for Health Technology Evaluation, said in a press release.

“Sofosbuvir-velpatasvir, a newer type of direct-acting anti-viral medicine, can be used to treat all genotypes of hepatitis C. Other drugs currently available treat only certain genotypes or can cause unwanted side effects if they have to be taken in combination with earlier anti-viral treatments. Our positive recommendation of sofosbuvir-velpatasvir means that more tolerable treatment options will become available to all patients with hepatitis C,” Longson said.

A 12-week treatment course with sofosbuvir-velpatasvir costs £38,980 (approximately $50,447 or €44,850). The drug also might be taken in combination with Ribavirin, also for 12 weeks, raising the cost to around £40,000. The NHS will pay less than these prices, however,  due to an agreed confidential discount with the company.

All preliminary recommendations are now available to the public for open consultation. Those interested may comment until Oct. 14.

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