Gilead Sciences Korea said that it got the Ministry of Food and Drug Safety’s approval to use Truvada as a drug to prevent, not just treat HIV-1/AIDS, a company official said Wednesday.

Truvada is a once-daily pill that is a fixed-dose combination of two antiretroviral medications - tenofovir disoproxil and emtricitabine – used alone or with other antiretroviral therapies to treat an HIV-1 infection. The drug does not cure either HIV-1 or AIDS.

Truvada

In Korea, Truvada had been only used to treat HIV-1 until recently, even though the U.S. Centers for Disease Control and Prevention had long recommended it for those at high risk for HIV to take the drug as a preventive measure. The U.S. FDA approved the expanded indication of Truvada as a preventive therapy in 2012.

Taking Truvada as a preventive step, also known as pre-exposure prophylaxis (PrEP), is a way for people who do not have HIV-1 but who are at substantial risk of contracting the disease to prevent infection.

Those at high-risk include males who have sex with other men, or people whose partners who are HIV-1 positive.

PrEP has shown to drop the risk of HIV infection by 92 percent when taken consistently, according to the U.S. Centers for Disease Control and Prevention. A pivotal PROUD study that studied men who had sex with men in Britain showed the risk reduction to be 86 percent.

The World Health Organization has also recommended that people at significant risk of HIV infection be offered PrEP to prevent the disease since Sept. 2015.

Now Koreans who are at risk for HIV-1 infection can also take Truvada to decrease the risk of contracting the disease.

Despite the good news, speculation is rising on how many people would be able to access the drug due to its price. According to officials related to Gilead Sciences Korea, one pill of Truvada in Korea will cost 13,730 won ($12.7), which translates to around 420,000 won ($390) a month.

Kim Tae-Hyong from Soon Chun Hyang University Hospital in Seoul’s department of infectious disease and member of Korean Society of Infectious Diseases noted that the successful uptake in the market would rely heavily on whether individuals without HIV would be willing to face both social and financial costs in Korea and take the pill daily to prevent the disease.

“We need to see how people will respond to the drug in our society,” Professor Kim said. “The success of Truvada will depend not on physician-led treatment but patient-led, or to be more exact people-led, treatment.”

“Clinical trials have proved the efficacy of the drug, sure, but it’s because the subjects were instructed to take it,” he said. “The drug can be said to be successful in the U.S. since people are taking the drug, but whether it will also be successful in Korea is another question.”

Meanwhile, an official related to Gilead Sciences Korea declined to comment on whether it will apply for reimbursement in the country, saying that it is too early to tell.

yjc@docdocdoc.co.kr

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