Gilead’s Truvada avoids cancelation of HIV treatment permit

Gilead Sciences’ HIV treatment and prevention drug Truvada (ingredient: emtricitabine/tenofovir disoproxil fumarate) avoided the regulator’s revocation of approval for HIV treatment.

According to the minutes of the Ministry of Food and Drug Safety (MFDS)’s central pharmaceutical affairs advisory committee, the panel reviewed Gilead’s plan for the post-marketing surveillance (PMS), submitted on Dec. 24, and decided to extend the PMS period by two years for the indication of HIV treatment.

In the past, the MFDS had designated Truvada as an orphan drug.

However, after Truvada added an indication of pre-exposure prophylaxis (PrEP) in 2019, Truvada lost its orphan drug status and became subject to the MFDS’ reassessment.

The HIV treatment was on the verge of losing the permit because it was unlikely to fulfill the number of PMS participants before the four-year reassessment period will end this month.

The MFDS’ advisory committee, however, granted a two-year extension of the PMS period and allowed Gilead to collect 68 cases through a retrospective census of new patients.

If the number of participants is insufficient again, the panel proposed that even after the extended PMS, the regulator should determine what to do based on the PMS results.

With the introduction of a new HIV drug, few patients get Truvada for HIV treatment.

According to Gilead, about 18 patients use Truvada for HIV treatment annually. Even with two more years of the PMS, it will be difficult to raise the number to 68.

“The purpose of re-evaluation is to secure the safety information of a new drug. But this (Truvada) is not a new drug,” one panelist said. “This has been widely used, and it has lots of safety data.”

Another said Truvada should remain available, saying HIV treatments tend to lack the number of patients in PMS, and different criteria should review them.

Members of the committee emphasized the importance of the HIV preventive effect of Truvada.

“Truvada is the only medicine that showed data of reduction in HIV infection rates in the U.S. and Taiwan,” a third panelist said. “As an infectious disease expert, I hope as many people can use Truvada as possible to lower the HIV infection rate.”

The government allows insurance benefits for Truvada PrEP therapy for people at risk due to sex with an HIV-positive partner. However, the benefit is not available for other high-risk groups.

Infectious disease experts said the government should widen the scope of reimbursement for Truvada for HIV infection high-risk groups who urgently need PrEP therapy.

A fourth panelist said that even though Truvada was introduced in Korea thanks to various efforts, insurance benefits were too limited.

“I hope government officials could broaden the use of the drug and ease regulations on re-evaluation so that this drug can remain available in the market,” the panelist said.

Another expert said Truvada was the only product used for PrEP therapy.

The expert said it is the government’s role to promote PrEP therapy to the general public because the treatment has a small patient population.