Rolling out TLD, a significant milestone for fighting HIV/Aids in Vietnam

Rolling out TLD, a significant milestone for fighting HIV/Aids in Vietnam The Marketing Authorization (MA) for Tenofovir/Lamivudine/Dolutegravir 300/300/50mg (TLD) in Vietnam has been granted by Ministry of Health (MoH) since 23 October, 2019 (Decision 563/QĐ-QLD). With this decision, people living with HIV/AIDS (PLWH) in Vietnam will soon benefit from the generic and superior HIV treatment regimen at an affordable cost.

This Antiretroviral drugs (ARV) containing three ingredients: tenofovir, lamivudine and dolutegravir is known as “TLD” for short. Dolutegravir (DTG) – the newest of the three drugs – is an integrated inhibitor that avoids the drug resistance. The World Health Organisation (WHO) and international health experts have recommended TLD as a preferred first-line ARV for HIV treatment1.

By mid-2019, TLD has been approved in 22 countries globally and 2 countries in the Asia Pacific Region. The fixed-dose combination tablet of TLD is now available at an affordable cost to low- and middle-income countries; the prices are expected to further decrease as the generic manufacturers are foreseen to increase their production. TLD currently costs 69 to 72 USD per person per year through the pool procurement of the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM)2.

“TLD has higher efficacy, fewer side effects and is easier to take.”

1 WHO - UPDATE OF RECOMMENDATIONS ON FIRST- AND SECOND-LINE ANTIRETROVIRAL REGIMENS JULY 2019. https://apps.who.int/iris/bitstream/handle/10665/325892/WHO-CDS-HIV-19.15-eng.pdf?ua=1 2 Source: The Medicines Patent Pool, May 2019

Vietnam – a PEPFARsupported country is prepared to achieve TLD transition by 2019 Since 2005, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) has continuously supported to provide ART for PLWH in Vietnam. From January 2020 on ward, the national Social Health Insurance (SHI) fund will be used to reimburse ARV drugs for HIV/AIDS patients in Vietnam.

Optimization of ARV regimens aims to ensure that PLWH in Vietnam can be accessed to the most appropriate medicines available in the most efficient and cost-effective way. From 2019, PEPFAR recommends that programs rapidly transition to the use of TLD as the preferred first line ARV regiment due it is superior effectiveness.

USAID Global Health Supply Chain Program - Procurement and Supply Management

“Granting MA for TLD, Vietnam is expected to be one of the first PEPFAR countries to achieve UNAIDS fast track target.”

Since 2018, the USAID Global Health Supply Chain Program – Procurement and Supply Management (GHSC-PSM) project has put huge efforts to support Vietnam Administration for HIV/AIDS Control/Ministry of Health (VAAC/MoH) and other related MoH departments in the whole process related to granting MA for TLD in Vietnam.

On the 23rd October 2019, the MA for TLD in Vietnam has been granted by the MoH. This is considered as a big milestone of the GHSC-PSM project as well as an achievement for PEPFAR, as of this is very critical for TLD importation and TLD transition plan implementation in Viet Nam. With supports from USAID, PEPFAR, the U.S Embassy in Hanoi and partners, the GHSC-PSM project, by its expertise, initiatives, flexibility and close follow up, has overcome many challenges to facilitate the TLD MA registration process in Vietnam. In the meantime, the GHSC-PSM project has placed TLD order from the manufacturer to ensure the availability as well as the most updated drug for TLD transition in Vietnam.

Upcoming challenges and next steps Rolling out TLD in Vietnam brings potential challenges. The GHSC-PSM project will continuously work closely with related partners to provide technical supports to facilitate the process for inclusion of TLD into the list of drugs covered by Viet Nam social health insurance.

With the GHSC-PSM project facilitation, the first TLD shipment of 160,000 bottles is expected to arrive in Vietnam by end of December 2019. This is great effort of the project to manage a smooth transition to ensure the continuation of an uninterrupted and sustainable supply of ARVs to Vietnamese HIV/AIDS patients. The GHSC-PSM will continue to help stakeholders in Vietnam to quantify the TLD needed for a smoothly transition.

USAID Global Health Supply Chain Program - Procurement and Supply Management