Two new treatment options for patients with hepatitis C are a step closer to being recommended for use in the NHS, following draft guidance from the National Institute for Health and Care Excellence.
NICE has recommended simeprevir (Olysio) in combination with peginterferon alfa and ribavirin for treating two hepatitis C in final draft guidance.
Simeprevir, manufactured by Janssen, has a marketing authorisation for treating two forms of hepatitis C – genotype 1 and genotype 4.
Genotype 1 hepatitis C is the most common type of chronic hepatitis C in England, accounting for around 46% of diagnoses. Genotype 4 hepatitis C accounts for around 4% of diagnoses.
“New treatments, like sofosbuvir, can shorten the duration of interferon-based therapy and in some cases don’t need to be taken with interferon at all”
The draft guidance recommends simeprevir, in combination with peginterferon alfa and ribavirin, as an option for treating both genotypes 1 and 4 chronic hepatitis C in adults.
The decision marks a change of mind from the institute, which had initially rejected the drug on cost-effectiveness grounds for genotype 4 in a previous draft of the guidance.
Simeprevir is administered orally and works by inhibiting the replication of the hepatitis C virus.
Professor Carole Longson, director of the NICE’s health technology evaluation centre, said: “The previous draft guidance did not recommend simeprevir for treating genotype 4 chronic hepatitis C and asked the company for more information on its use for this group of patients.
“Based on the information received the independent appraisal committee concluded that simeprevir, in combination with peginterferon alfa and ribavirin, is a cost effective treatment option for people with genotypes 1 and 4 chronic hepatitis C,” she said.
In another set of final draft guidance published today, NICE has extended an earlier recommendation for sofosbuvir (Sovaldi) for chronic hepatitis C. It now also recommends the use of sofosbuvir as an option for some people with genotypes 4, 5 and 6.
Sofosbuvir, a once-daily oral therapy, is the first in a new class of antivirals used to prevent hepatitis C viral replication in infected cells. It is manufactured by Gilead.
Professor Longson said: “Current interferon-based treatments for chronic hepatitis C, which often need to be given for a long period of time, are associated with a number of often unpleasant side-effects such as chronic fatigue, neuropsychological effects and flu-like symptoms.
“New treatments, like sofosbuvir, can shorten the duration of interferon-based therapy and in some cases don’t need to be taken with interferon at all,” she said.
“Sofosbuvir can also be given to people who have previously been treated but did not clear the virus, in people whose condition has relapsed, or in people who have become re-infected after treatment,” she added.
However, NICE noted that NHS England had requested more time to get services and resources in place to comply with the final guideline on sofosbuvir when it is published later this year. As a result, there is likely to be a delay of around six months after the guidance is ratified before the drug becomes available.
Meanwhile, NICE said separate guidance would in future be developed on the use of simeprevir in combination with sofosbuvir for patients who cannot tolerate interferon – but after forthcoming trial data was published.
The two sets of draft NICE guidance are currently open to consultation from stakeholder groups who have the opportunity to appeal against it.
Once NICE issues its final guidance on the treatments, it replaces local recommendations across the country.
Final guidance on both sofosbuvir and simeprevir in combination with peginterferon alfa and ribavirin for chronic hepatitis C is due to be published in February 2015.