Long-acting, China-developed AIDS drug getting final review

China's domestically developed, long-acting experimental AIDS drug is undergoing a final review by the China Food and Drug Administration, the last stage in the approval process.

Different from traditional oral drugs that require daily use, Albuvirtide is an injection solution that can be administered weekly.

"In developed countries, oral AIDS drugs are very efficient, but it's a heavy burden for patients to take medicine every day for years," said Xie Dong, chairman of Frontier Biotechnologies, the Nanjing company that developed the drug.

"As a result, long-acting drugs are the future direction in developing innovative AIDS medicine."

For Chinese patients, the number of oral drugs available in the domestic market is very limited, "so there is an urgent need for drugs to solve the problem of drug resistance", he added.

Zhao Yan, a treatment specialist at the National Center for AIDS and Sexually Transmitted Disease Control and Prevention, said seven or eight oral drugs for AIDS are currently provided to patients for free.

"The injection solution could give an alternative to patients ... if it could be included in the country's health insurance system," she said.

"Now very few patients are using drugs from the health insurance system, both because no differentiated drugs are provided and because the procedure is more complex and could harm their privacy," she said. "New drugs will be broadly used only if the system can embrace more varieties of drugs."

Albuvirtide went into the research and development stage in 2002 and entered phase three of clinical trials - a step to assure safety and effectiveness before market approval - in 2014.

Phase three is the last round of clinical trials for new drug tests in China. If the drug can pass the reviews of the country's drug watchdog, usually at least two rounds, it can then enter the market. The time needed for the review ranges from months to years.

"Clinical trials showed that the new drug performs even better than the oral drugs being used," said Wu Hao, an expert in infectious diseases at Beijing You'an Hospital who was involved in the clinical trials.

According to Wu, most of the oral drugs for AIDS being used in China are generic drugs developed in the 1970s and '80s that are not so efficient.

"In terms of safety and effectiveness, evidence so far showed that Albuvirtide is better than most second-line drugs - drugs used when first-line standard drugs fail - in developed countries because of lower toxicity and fewer side effects," he said.

Worldwide, a number of long-acting AIDS drug are in development. None has been approved for sale. Only Albuvirtide and a few in the United States have entered phase three of clinical trials.

By the end of last year, 577,000 people in China were living with HIV. With an estimated infection rate of six people per 10,000 population, 32.1 percent of infected people are believed to be unreported.

Shan Juan contributed to this story.

chengyingqi@chinadaily.com.cn