A program to introduce an innovative method of pre-exposure prophylaxis for HIV infection has been launched in Ukraine – long-acting injectable cabotegravir, which, if used in accordance with medical recommendations, protects against HIV infection through sexual contact by 99%. 

The supply of long-acting cabotegravir was made possible through a partnership between the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and ViiV Healthcare. Implementation of the project in Ukraine was organized by the Public Health Center of the Ministry of Health of Ukraine in partnership with the PEPFAR Coordination Office, CDC, USAID, WHO, ICF “Alliance for Public Health”, and NGO “ALLIANCE.GLOBAL”. 

After a systematic review of the evidence and results of the studies WHO recommends the use of CAB-LA for PrEP.   The availability of the medication in Ukraine will allow expanding the access and coverage of pre-exposure prophylaxis services, as well as HIV prevention in general, which is especially important in a time of war. The offer of injectable cabotegravir along with tablet forms of PrEP (TDF/FTC) provides a possibility of choice: regular oral medication or an injectable, extended-release version. 

“Pre-exposure prophylaxis is one of the evidence-based methods of controlling the HIV epidemic in the world. Over the past 3 years, the number of people receiving pre-exposure prophylaxis in Ukraine has tripled. Ukraine has been selected as one of 5 countries among the PEPFAR partner countries prioritized for expanding access to the injectable form of pre-exposure prophylaxis – long-acting cabotegravir. This is a modern innovative drug that will be available in medical institutions of the two cities after the registration is completed,” said Ihor Kuzin, Deputy Minister, Chief State Sanitary Doctor of Ukraine, during a joint press conference in Kyiv. 

According to Mykhailo Rosada, Director General of the Public Health Center of MOH Ukraine, the introduction of the newest pre-exposure prophylaxis medication in Ukraine was made possible by the strong cooperation of the Public Health Center, the PEPFAR team, the ICF Alliance for Public Health, the NGO ALLIANCE.GLOBAL, and WHO. 

The PHC, together with partners, created a Working Group on the organization of the introduction of injectable drugs for HIV prevention, selected specialists for implementation teams, and developed operational manuals and clinical pathways. PEPFAR has centrally procured CAB-LA in the amount of 1,350 vials, which corresponds to almost 200 annual courses, and transferred them to the PHC as the project implementer.

“Until recently, HIV was called the ‘plague of the 21st century’. Today, we can –  not only to control the disease, but also prevent it by 99%. This is the efficacy rate of Cabotegravir, an innovative sustained-release drug for pre-exposure prophylaxis of HIV. I am grateful to our international partners for their strong support and cooperation, which helps to save and preserve the lives of Ukrainians,” said Mykhailo Rosada, Director General of Public Health Center of MOH.

Ukraine became one of the few PEPFAR partner countries to be the first to implement the CAB-LA program. A roadmap for the introduction of long-acting cabotegravir as pre-exposure prophylaxis for HIV in Ukraine was developed and approved, and negotiations were held with representatives of health care institutions in Lviv and Kyiv to implement CAB-LA. 

“We are very pleased that Ukraine has applied to participate in the first wave of CAB-LA rollout. Given the risks associated with the war and the constant displacement of the population, we are confident that this highly effective and innovative drug will be a convenient alternative in Ukraine. Thanks to the commitment and professionalism of our government and civil society partners in Ukraine, I am confident that together we can end the HIV epidemic,” said Brendan T. Garvin, Director of Management and Budget at U.S. PEPFAR.

CAB-LA implementation is planned to start in Kyiv (Kyiv City Clinical Hospital #5) and Lviv (Lviv Regional Phthisiopulmonary Clinical Treatment and Diagnostic Center of the Lviv Regional Council) for the MSM group (men who have sex with men). 

Andriy Klepikov, Executive Director of the Alliance for Public Health, shared his experience of advocating for this opportunity for Ukraine:

“This is a truly remarkable day: Ukraine was the first country in the Eastern Europe and Central Asia region to receive the most modern drug for pre-exposure prophylaxis of HIV infection. For 3 years, we had been negotiating and arguing the need for CAB-LA, but often heard that it was not the right time. However, we did not lose our motivation and kept moving forward. Ukraine won this right through successful negotiations and the trust of its partners. This program is being launched thanks to the support of the US Government under the PEPFAR program. Despite the challenges of war, Ukraine is a leader in the implementation of innovative technologies in HIV prevention.”

Andrii Bogoslavets, Head of the Pre-Exposure Prophylaxis and Information Campaigns Project at ALLIANCE.GLOBAL, said: “The organization has been working with the support of international donors and the ICF Alliance for Public Health to distribute PrEP among the community since 2018, and we  understand how important PrEP is in overcoming the HIV epidemic. PrEP tablets are an effective solution to protect against HIV infection. When taken daily, it protects against HIV by up to 99% and has become a know-how in overcoming the HIV epidemic.  Today, we presented an injectable form of PrEP, which will be a great solution for those members of the community who may miss taking pills on a daily basis. And the fact that cabotegravir needs to be injected every two months is a great solution for the community, which will protect 99%. Knowing the feedback from, the community is looking forward to when this drug will be available and hopes that after this pilot project there will be an expansion when this medication will be available in all cities of Ukraine”. 

Background: 

Long-acting cabotegravir (CAB-LA) is a long-acting injectable drug that belongs to the class of integrase chain transfer inhibitors (a class of antiretroviral drugs). CAB-LA is indicated for pre-exposure prophylaxis of HIV infection for adults weighing at least 35 kg and is used to reduce the risk of sexual transmission of HIV-1. The use of CAB-LA involves the intramuscular injection of 2 doses of the drug with an interval of 4 weeks, then one injection every 8 weeks. In July 2022, the WHO included Cabotegravir in its recommendations for pre-exposure prophylaxis of HIV infection, which was approved by the US Food and Drug Administration (FDA) on December 20, 2021. 

To date, CAB-LA is the only sustained-release injectable that has demonstrated high efficacy in randomized clinical trials (HPTN 083 in cisgender men and transgender women who have sex with men; HPTN 084 in cisgender women in sub-Saharan Africa). 

Expanding HIV prevention choices is an important element of the public health approach to reducing new HIV infections. Offering additional PrEP options has the potential to increase PrEP coverage and effective use, as well as HIV prevention in general, by allowing people to choose the method they prefer.

Recording of the press conference:
https://www.youtube.com/live/OEs_y92A3Rs?si=nSDm7MkHO05Z6Yu9