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U.S. drug for AIDS prevention to be reviewed for use in Korea

By Claire Lee
  • Published : May 17, 2016 - 17:04
  • Updated : May 17, 2016 - 17:29
A Food and Drug Administration-approved HIV drug developed in the U.S. will be submitted for review in Korea to be used as a preventive medicine for people at high risk of infection, its developer Gilead Sciences said on Tuesday.

The drug, named Truvada, is already being used in South Korea as part of treatment for patients with HIV here. The upcoming submission, which is scheduled to be made in the second half of this year, seeks to be recognized by the Korean Drug Ministry as “pre-exposure prophylaxis” – or PrEP – a preventive medicine for those who do not have HIV or AIDS.

“We think we’ll get our response from the Korean Ministry of Food and Drug Safety sometime next year, probably after June,” an official from Gilead Sciences told The Korea Herald. “Once we get the ministry’s approval, we can officially label the drug as PrEP.”

In Korea, the drug is currently mostly prescribed for the treatment of HIV and AIDS patients. For prevention, the drug is only prescribed to health care workers, newborns born to HIV-positive parents, men and women who are legally married to patients infected with HIV or AIDS, including those in common-law marriages.  Gay marriage is not legally recognized in Korea.
Yonhap
Under the current system in Korea, men who have sex with men -- who are known to be 19 times more likely to be living with HIV than the general population,  according to UNAIDS, the joint U.N. program on HIV and AIDs -- do not have access to the drug for prevention.

An industry source who did not wish to be named said although it is more likely that more Koreans would gain access to the drug once Truvada is approved as PrEP, it is currently difficult to predict what is going to happen.

“A lot of sensitive issues, such as LGBT rights and possible stigmatization, are involved with the use of this drug as a preventive medicine,” she said. “For example, there may be a possible stigma against those who prescribe the drug for preventive purposes. There’s also the issue of privacy and how we are going to protect the relevant personal data.”

In the U.S., Truvada was approved as PrEP by the FDA back in 2012. According to the Centers for Disease Control and Prevention of the U.S., daily PrEP use can lower the risk of getting HIV and AIDS from sex by more than 90 percent.

PrEP, however, does not work in the same way as a vaccine. Unlike a vaccine that teaches one’s body to fight off infection for several years, PrEP, which come in the form of pills, is required to be taken orally every day. The presence of the medicine in one’s bloodstream is known to stop HIV from spreading in the body.

The cost of the drug is currently covered by the Korea’s National Health Insurance for HIV and AIDS patients. It costs 13,730 won ($12) per pill.

According to the Korea Centers for Disease Control and Prevention, a total of 12,757 AIDS cases were reported in Korea from 1985-2014. Among them, 92.4 percent of the newly reported patients in 2014 were male. Also, 99.8 percent of them were infected through sex.

By Claire Lee (dyc@heraldcorp.com)