Drug approvals for hep C candidates not fast enough in China

If China is indeed improving its drug regulatory system, it isn't happening fast enough for hundreds of thousands of hepatitis C patients still reliant on expensive imports for a good treatment, or who can't travel abroad for cutting-edge therapies. That, in a country with 10% of the world's cases of the liver-destroying disease.

The situation leaves those who cannot afford the imports with what is still the standard treatment in China: interferon/ribavirin, both antiretroviral with side effects that half the recipients cannot tolerate.

If mainland China patients could step across into Hong Kong or go elsewhere, they could obtain what has become the standard treatment, direct-acting antivirals (DAAs) capable of curing 95% of hep C cases.

In a lengthy, several-part article, the state-run newspaper, China Daily, noted the gap in treatment and access and blamed it on China FDA's slow approval process that usually takes more than 5 years, longer than some patients can live without proper treatment.

As elsewhere, 80% of hep C patients develop a chronic infection that can develop into cirrhosis or scarring of the liver, in turn leading to its failure or cancer within three decades. The interferon/ribavirin treatment, which has to be injected, keeps the disease under control at a low infection level, but has only a 70% cure rate.

In addition, a recent survey by 28 China hospitals showed that half the antiretroviral patients have serious reactions to the treatment. Local specialists in treating the disease said patients were in a "race against death," and joined various organizations and patient groups in pushing for faster CFDA reviews.

Mainland China counted 350,000 people diagnosed with liver cancer last year and counts 380,000 cancer-related diseases annually. Its surveys also show that 80% of those cancer cases were caused chronic hepatitis in general, not just C.

In the midst of revising its rules and guidelines for conducting clinical trials, the agency has several types of direct-acting antivirals stuck in its lengthy review process.

At the same time, because it has not approved such drugs for use in China, the CFDA considers imported drugs to be fake and illegal, leading desperate patients to defy the law and order the drugs online from abroad.

One drug under review is Gilead Sciences' ($GILD) oral Sovaldi (sofosbuvir), which has a 95% cure rate with fewer side effects and costs $84,000 for a 12-week course, or $1,000 per pill in the U.S.

Pricing for the HCV treatment, if approved, in China is in sharp focus as Gilead is still working with Chinese regulators on approval for Sovaldi and is in talks separately with China on possible pricing, the company recently told FiercePharmaAsia.

The focus in China for chronic hepatitis C is genotype 1b, experts say, with nearly two-thirds of the 30 million estimated cases in that category.

A patient-group leader, who said he was cured by DAAs he bought online from abroad, said most patients would trade all they have for a cure, so they should at least have that choice to buy sofosbuvir or as part of combinations.

China authorities could join the 20-year-old International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use that lets member countries rely on the results of trials conducted by other members to be used in deciding whether to approve a drug without duplicating the trials in China. China still has not joined and insists its lengthy process must be followed.

India, with an equal population, was able to negotiate an agreement with Gilead to allow 9 generics makers to market Sovaldi at $900 per course in emerging markets, but Gilead excluded China as well as Brazil, Mexico and Thailand from the deal.

The newspaper said similar problems exist with many other diseases in China, including HIV/AIDS. To make matters worse, experts estimate that only 10% of the nation's hep C cases are detected, and only half of those seek treatment.

- here's the story from China Daily