Disease and healthcare utilisation burden without treatment

Two recently published studies highlight the extent to which untreated hepatitis C infection will lead to substantial costs for health systems as a result of untreated liver disease.

A study of hepatitis C treatment uptake in England found that only 3% of people with chronic hepatitis C infection are treated each year. An estimated 160,000 people have hepatitis C. Doubling the uptake of new direct-acting antivirals to treat everyone with hepatitis C would cost £1.4 billion over the next 30 years. Continuing to treat the same number of people each year without any increase in treatment coverage would lead to healthcare costs of £4.6 billion over the next 30 years as people progress to end-stage liver disease.

In the United States, a study of healthcare utilisation by people living with hepatitis found that over the ten-year period from 2001 to 2010, liver-related health problems in people with hepatitis C cost $7.5 billion to treat.

A recent analysis of healthcare costs versus hepatitis C treatment costs in the United States suggests that hepatitis C treatment numbers will peak in 2016 at around 80,000 a year, but that treatment costs will fall rapidly after 2017 as the backlog of untreated patients begins to decline.

Recent European decisions on reimbursement for sofosbuvir treatment of hepatitis C

Despite the mounting evidence of the long-term costs of not treating hepatitis C, bodies responsible for reimbursement and cost-effectiveness decisions continue to question the cost attached to the use of sofosbuvir (Sovaldi).

This month, the body responsible for issuing guidance on medicines for England and Wales, NICE (National Institute for Health and Care Excellence), issued draft guidance stating that sofosbuvir may not be approved for prescription in England and Wales. The agency asked for further cost-effectiveness analyses looking at the use of sofosbuvir in genotypes 1 and 3 and for a comparison of cost-effectiveness in patients with and without cirrhosis.

A 12-week course of treatment with sofosbuvir will cost £34,983 ($59,385) in the United Kingdom.

NHS England agreed to provide funding to pay for sofosbuvir treatment for people with acute liver failure and/or those awaiting liver transplantation, and for those at high risk of death or irreversible liver damage due to liver disease within the next year. The funding will provide treatment for approximately 500 people in the next year.

In Scotland, which runs a separate system for approving medical costs within the United Kingdom, the Scottish Medicines Consortium has approved the use of sofosbuvir for most genotypes with the exception of untreated patients with genotype 2 infection.

Merck buys Idenix to improve its hepatitis C portfolio

Merck has bought the biotechnology company Idenix for $3.85 billion in what market analysts have described as a challenge to Gilead’s dominance of the hepatitis C market. Merck’s aim is to develop a single-tablet regimen that will cure all genotypes of hepatitis C in four to six weeks.

Merck will take a nucleotide polymerase inhibitor developed by Idenix and test it in combination with its NS5B inhibitor MK-8742 and its protease inhibitor MK-5172.

BMS aims to test four-week treatment course for HCV

Bristol-Myers Squibb (BMS) is planning a clinical trial to test whether it is possible to cure hepatitis C in four week using sofosbuvir (Sovaldi) in combination with its investigational direct-acting antivirals daclatasvir, asunaprevir and BMS-791325.

Currently available treatment regimens must be taken for between 12 and 48 weeks according to HCV genotype and treatment history. Gilead Sciences is seeking marketing approval for an 8- or 12-week treatment course using a combination of sofosbuvir and ledipasvir.

Now Bristol-Myers Squibb is reviving research into the use of its promising NS5A inhibitor daclatasvir, its protease inhibitor asunaprevir and its polymerase inhibitor BMS-791325 in combination with Gilead’s sofosbuvir. Preliminary studies showed that this combination was highly effective, but Gilead chose to pursue development of a combination of its own drugs. Bristol-Myers Squibb plans to begin a preliminary study of a four-week regimen involving people with genotype 1 hepatitis C within the next few weeks, with larger studies to follow if the combination cures more than 90% of participants.

As well as being attractive for patients and doctors, a four-week treatment course could prove to be cheaper, allowing more people to be treated. Daclatasvir and asunaprevir are active against genotypes 1 and 4. Bristol-Myers Squibb has already submitted a licensing application for approval of daclatasvir and asunaprevir in the United States for treatment of genotype 1b HCV infection.

Faldaprevir discontinued

Boehringer Ingelheim has announced that it will discontinue development of its investigational HCV protease inhibitor faldaprevir. The company says that the drug was developed on the assumption that it would be used with pegylated interferon, but the hepatitis C market is changing so quickly that interferon-free regimens will be approved soon for genotype 1. Boehringer Ingelheim says it has halted any further work on developing drugs to treat hepatitis C.

Achillion development plans

The biotechnology company Achillion has been given permission to resume studies of its investigational hepatitis C protease inhibitor sovaprevir. Studies were halted due to safety concerns. The company also announced plans to study a nucleotide polymerase inhibitor. The company also has an NS5A inhibitor in phase 2 studies, and hopes that it will be able to develop dual or triple regimens for treatment of hepatitis C.

Getting ready for World Hepatitis Day?

For many of us in Europe who work in hepatitis, or are patient advocates, World Hepatitis Day on 28 July offers an opportunity to get people talking about hepatitis. This year’s theme is Hepatitis: Think again.

The World Hepatitis Alliance has put together free campaign materials, including posters which you can adapt online.

You can also use the official World Hepatitis Day website to join social media campaigns, and to use the events listing, where you can search for events near you or add any related events you are involved with. Find out more at: www.worldhepatitisday.org

We would love to know what you are planning! Email us to let us know at info@infohep.org

New! Hepatitis C treatment factsheets

At the International Liver Congress, we launched three new hepatitis C treatment factsheets.

Each factsheet focuses on one direct-acting antiviral drug and gives an overview of how it works, who can use it, how it is taken, what trial results tell us about how effective it is, known side-effects and drug interactions.

The factsheets are available to read online, and are also designed to be printed and shared. Find out more in the infohep.org blog.

New! Customise your hepatitis information

We have also recently developed a simple tool to customise the hepatitis treatment information on infohep.org.

For example, you can choose to search for information according to the genotype it is relevant to, or information relevant for people who have taken treatment before.

Answer a few simple questions, and the information presented will be our news reporting on the studies relevant to your search.

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