In a recent study funded by the Patient-Centered Outcomes Research Institute, it has been shown that newer treatments for hepatitis C appear to eliminate the virus, mostly in those taking oral antiviral medications.

The oral medications "work really well in most patients that have hepatitis C," said Dr Oluwaseun Falade-Nwulia, the study's lead author and assistant professor of medicine at Johns Hopkins University School of Medicine in Baltimore.

The study looked at 42 published clinical trials of adults with chronic hepatitis C infection involving interferon-free treatment regimens of two or more medicines. Most patients have a 95% chance of being cured - the hepatitis C virus is no longer detectable in the bloodstream - the study showed.

The medicines did not work on patients with chronic kidney disease, with a remission rate of at least 90%. There is also a very low risk of side effects, yielding the fact that these therapies are very safe. In addition, many patients can be treated in just 12 weeks.

Patient advocacy groups constantly challenge patents

One of the oral medications is a pill called Epclusa that the FDA approved in June 2016. The pill's manufacturer, Gilead Sciences, sells the medication for approximately USD890 per pill or USD74,760 for 12 weeks.

The steep pricing is not new. Gilead has previously caused controversy for selling Sovaldi - another hepatitis C drug - with a starting price point of USD84,000 for a 12-week supply, or USD1,000 per pill. Patient groups claim that the only way to stop the high pricing is to challenge patents.

As such, Medecins du Monde and Doctors Without Borders have led a recent challenge in Europe - where Gilead is seeking to file a patent for Sovaldi - claiming that the patent is not warranted under European laws.

Specifically, they claim that the base compound is nothing new, as such, not unique enough that someone else could not have created it. Medecins du Monde has also separately challenged a Sovaldi patent two years ago and last fall, the European Patent Office amended the patent after reviewing Gilead's claims, but the Sovaldi patents still expire in 2028.

Bringing down the cost through generics

This latest challenge is in fact, one of many, by various patient advocacy groups who argue that Gilead has filed patent claims that unfairly allowed it to monopolise the market for hepatitis C treatments in numerous countries, especially in middle-income nations like Malaysia, Indonesia, Mexico, Australia, India and fourteen other countries.

In the past two years, patent challenges saw success in China and Ukraine, while others in Brazil, Argentina, Thailand, Egypt and Russia are still ongoing. Gilead managed to fend off a challenge in India, but is currently being appealed.

Two years ago, the company settled with several Indian generic drug makers to sell low-cost versions in 91 low-income countries and also struck separate deals with some other countries, such as France. By filing these challenges, the groups hope to expand the number of generic companies that can make copies and either export them to other countries or serve local populations.

Medicines effective, but will not wipe out hepatitis C yet

However, Gilead has reported a slowdown in hepatitis C drug sales as the initial large number of people who were rapidly treated with the medicines have improved, therefore leaving a smaller pool of patients who may be eligible for treatment.

Scientists at the US National Institutes of Health however, caution that the new treatments fall short of a "cure" - despite the positive results of the Hopkins study and Gilead's slowdown of drug sales.

"Hepatitis C is down but not out," Dr Jay Hoofnagle and Dr Averell Sherker wrote in an editorial accompanying the study. Both are program directors with the US National Institute of Diabetes and Digestive and Kidney Diseases.

Both Hoofnagle and Sherker highlights that although the response rates to the new antivirals are high, they are not 100% and it was important for the general public to realise that although therapies for hepatitis C have matured, the situation will not get significantly better.

The biggest barrier is still the cost of drugs as "the only way you can eliminate a disease is if you treat everybody who's affected," said Falade-Nwulia. MIMS


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