Gilead's HIV treatment and prevention drug Truvada (emtricitabine/tenofovir disoproxil fumarate) has survived after a series of twists and turns in the Korean market.

According to the minutes of the Central Pharmaceutical Deliberation Committee (CPDC) meeting released by the Ministry of Food and Drug Safety last Friday, the number of post-market surveillance (PMS) cases of Truvada was reduced from 68 to 20, fulfilling the requirements for re-examination.

The meeting was held in writing from Jan. 22-24 to discuss the feasibility of changing the number of patients targeted for Truvada's PMS.

The ministry had already already adjusted Truvada's PMS plan once in 2022.

Truvada was designated as an orphan drug when it was introduced in Korea for HIV "treatment," but was removed from orphan drug status in 2019 when its indication was expanded to "prophylactic therapy" and was subject to re-examination.

However, when Truvada failed to meet the number of PMS cases within the re-examination period and was at risk of revoking its license in 2022, the ministry extended the deadline for another two years.

Two more years passed, but Truvada still failed to meet the planned number of cases of 68.

This time, the ministry tabled an agenda item to reduce the number of PMS cases to 20, and all members of the CDPC agreed to reduce the number of PMS cases for Truvada.

The committee members agreed that Truvada's actual use is very low due to the use of three-drug combinations for HIV treatment. They also shared that it is the only drug licensed for prophylaxis in Korea. Moreover, Truvada is designated on the World Health Organization's Essential Medicines List and is included in the Korea Disease Control and Prevention Agency's (KDCA) AIDS Prevention Program.

Besides, the committee members acknowledged that despite the company's (Gilead's) efforts, recruiting cases in the Korean clinical environment is difficult.

They agreed that Truvada is rarely used to treat HIV. When used as prevention, it is only covered for high-risk individuals (partners of infected individuals), making it difficult to recruit patients and obtain informed consent.

As a result, Truvada was found to have met its adjusted case count. According to the minutes, Gilead had recruited 22 eligible patients by the extension deadline.

Truvada has met the case count by the review deadline of February and will retain its domestic license, according to the minutes.