Tag Archives: hep c

Hepatitis C drug delayed by NHS due to high cost

One in three people infected with hepatitis C will develop liver cirrhosis and some will get cancer. Photograph: Bsip/UIG via Getty Images

One in three people infected with hepatitis C will develop liver cirrhosis and some will get cancer. Photograph: Bsip/UIG via Getty Images

The NHS is to delay the introduction of a highly expensive drug that can save the lives of people infected with the hepatitis C virus. The move by NHS England is unprecedented, because the NHS rationing body, Nice (the National Institute for Health and Care Excellence) has approved the drug. Nice says sofosbuvir is cost-effective, because it is a cure for people who would otherwise run up huge NHS bills.

One in three people infected with hepatitis C will develop liver cirrhosis and some will get cancer. A liver transplant costs more than £50,000.

But NHS England appears to be balking at the bill for the drug, which would hit £1bn for every 20,000 people treated. Approximately 160,000 people in England alone are infected with hepatitis C, although fewer than half are aware of it.

Sofosbuvir has been hailed internationally as a breakthrough, but there is global concern over the very high cost of a drug that can save lives. Campaigners are pressing for lower prices, from the US – where it costs $1,000 a pill – to India, in a fight which they liken to that over drugs against another virus: HIV, which causes Aids. On Wednesday, they celebrated a decision by the Indian authorities not to allow a patent application for sofosbuvir by Gilead, the manufacturer, which means Indian companies may be able to make cheap copies for the developing world.

The price offered by Gilead in the UK is almost £35,000 for a 12-week course. Many patients will need a 24-week course, costing £70,000. In its final draft guidance on sofosbuvir, Nice said it was allowing NHS England to postpone implementation for four months, until the end of July instead the beginning of April. NHS England failed to comment.

Charles Gore, chief executive of the Hepatitis C Trust, said he was very concerned about the delay. Nice had allowed NHS England to make a decision based on affordability rather than cost-effectiveness. “It feels to me as if a whole new criterion has been invented by the backdoor,” he said. If the NHS could delay using a new drug by four months, it could also delay by six months or a year – or it could decide on the basis of its cash-strapped budget to use it one year but not the next.

“It is undoubtedly a high cost,” said Gore. “The unfortunate thing is there are an awful lot of people who need it. We’re talking about potentially hundreds of thousands of people. That becomes a massive budget-buster.”

NHS England has introduced a scheme to pay for the treatment of people who are very ill – many of them on liver transplant waiting lists. In April, it announced an £18.7m fund to pay for 500 patients with acute liver failure.

But Mark Thursz, professor of hepatology at Imperial College London and chair of the Hepatitis C Coalition, said there were others who needed treatment as soon as possible. “The delay is unprecedented,” he said. “What worries me about it is that if you have got advanced liver disease with hepatitis C, you could progress at any stage to the point where it is very difficult or impossible to reverse the situation or have any improvement. Opportunities are being missed by any delay.”

About 10,000 to 15,000 of people with hepatitis C infection in the UK have cirrhosis, he said. Around 5,000 have advanced disease and need treatment soon if they are not to suffer long-term damage.

Hepatitis C is spread by contact with infected blood. Some people live with it unknowingly for years having injected drugs in their youth, while some got it from blood transplants before screening for the virus was introduced. It is also thought to be spread by sharing razors or toothbrushes with those infected.

There are older drugs but the treatment lasts up to four years and has serious side-effects, including depression. Sofosbuvir is a once-daily pill, taken with one or two other drugs for 12 or 24 weeks

Stelios Karagiannoglou, Gilead’s general manager, UK and Ireland, said the company was pleased with the Nice decision. But he added: “We are disappointed that the majority of patients will not gain access to this important medicine until later this year.” He called on NHS England to commit to a scheme from April offering early treatment for people with cirrhosis.

Story via The Guardian

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Will New Drugs Block Hepatitis C Virus in Its Tracks?

Targeted multi-drug treatments for hepatitis C patients that could stop the virus in its tracks have come a step closer, thanks to researchers at the University of Leeds, UK.

The study by Dr Stephen Griffin and colleagues, published in the journal Hepatology, reveals how two prototype small molecule drugs, known as p7 inhibitors, can each attack different parts of the hepatitis C virus. Their findings suggest that p7 inhibitors could be a powerful way of suppressing hepatitis C, when used together with the latest generation of ‘direct-acting’ drugs.

More than 170 million people — or 3% of the world’s population — are infected with the hepatitis C virus. The virus causes severe liver disease and is a leading cause of liver-related deaths, organ transplants and liver cancer.

At the moment, patients are typically treated with PEGylated interferon alpha (IFN) and ribavirin (Rib) — drugs that work by boosting the patient’s immune system. However, the effects of these drugs can depend on the individual patient’s genetic make-up. To make matters worse, hepatitis C is often resistant to the therapy and fails to suppress the virus for long enough. The treatment is also expensive and can trigger unpleasant side effects. Many patients stop taking the drugs or do not take them when they should.

To address this, researchers are looking at new classes of drugs that work in a different way to either IFN or Rib and target the virus directly. The aim is to find groups of these ‘direct-acting’ drugs that each attack a different target, making it much, much harder for the virus to fight back.

University of Leeds researchers are focusing on drugs that target the p7 ion channel — a protein made by hepatitis C that allows the virus to continue spreading. In previous studies, Dr Griffin and colleagues worked out how the p7 ion channel could be blocked by certain types of small molecule, stopping the hepatitis C virus in its tracks. Their latest work looks at two particular classes of p7 inhibitor — adamantanes and alkylated imino-sugars — and confirms that these molecules do, indeed, attack their intended target through separate mechanisms.

The researchers used a combination of molecular modelling and lab-based experiments to study the drugs’ interaction with hepatitis C. Importantly they observed how the virus responded to the two types of drug and determined that each of these responses was very different. This suggests that the drugs would work well in combination, tackling the virus on a number of fronts.

Lead author, researcher Dr Stephen Griffin, from the University of Leeds’ School of Medicine, said: “Hepatitis C has always been an extremely difficult condition to treat effectively because the virus evolves so quickly and develops resistance to drugs that are used to treat it. This new class of small molecule drugs, the p7 inhibitors, attack the virus directly. As we have discovered here, they each do so in quite a different way which allows us to combine their effects.

“By learning how the hepatitis C virus reacts to these molecules, we can design drugs that are likely to be more effective for longer. We can also see how such drugs could be used together with other ‘direct-acting’ drugs that target alternative viral targets, rather than individually or with IFN/Rib. In other words, a similar approach to treatment as that used for HIV.”

The study was conducted in collaboration with Professor Mark Harris (University of Leeds, Faculty of Biological Sciences), Professor Colin Fishwick and Dr Richard Foster (University of Leeds, School of Chemistry) and Professor Steven Weinman (University of Kansas).

The work was funded by the UK Medical Research Council, Yorkshire Cancer Research and the University of Leeds Biomedical and Health Research Centre.

Background

Approximately 3% (170 million) of the world’s population has been infected with the hepatitis C virus (HCV). For most countries, the prevalence of HCV infection is less than 3%. The prevalence is higher (up to 15%) in some countries in Africa and Asia, and highest (over 15%) in Egypt.

Chronic hepatitis C can cause cirrhosis, liver failure, and liver cancer. Researchers estimate that at least 20 percent of patients with chronic hepatitis C develop cirrhosis. Hepatitis C is the cause of about half of cases of primary liver cancer in the developed world. Men, alcoholics, patients with cirrhosis, people over age 40, and those infected for 20 to 40 years are at higher risk of developing HCV-related liver cancer.

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