Zimbabwe Approves Six-Monthly HIV Prevention Injection

By Delicious Mathuthu

Harare - Zimbabwe has become one of the first African nations to authorise Lenacapavir, the twice-yearly injectable that prevents the Human Immunodeficiency Virus (HIV) with high efficacy, granting full registration in just 23 days.Authorities say this is the fastest approval ever recorded by the country’s medicines regulator.

Medicines Control Authority of Zimbabwe (MCAZ) announced Friday November 21, that the long-acting pre-exposure prophylaxis (PrEP) drug, developed by the United State of America (US) pharmaceutical giant Gilead Sciences, was fully approved only 23 days after the company submitted its application on 29 October.

“The rapid approval of Lenacapavir reflects MCAZ’s dedication to accelerating access to trusted, high-quality health products.

"This milestone brings new hope for HIV prevention and reinforces our commitment to safeguarding public health,” MCAZ Director-General Richard Rukwata (pictured) said in a statement.

Lenacapavir is administered as two starter injections followed by a single subcutaneous shot every six months, offering a dramatic alternative to daily oral pills.It is approved for HIV-negative adults and adolescents weighing at least 35 kg who are at substantial risk, and must be combined with condoms and other safer-sex practices.

“This product has the potential to improve adherence and expand prevention options for populations most vulnerable to HIV infection,” the authority said.

They added that the approval is a significant advancement in Zimbabwe’s national HIV strategy.

The move directly aligns with the Zimbabwe National HIV and AIDS (Acquired Immuno Deficiency Syndrome) Strategic Plan (ZNASP IV) 2021-2025, the latest policy from the National AIDS Council (NAC), which underwent a mid-term review in 2023 to refine targets amid Global Fund transitions.

ZNASP IV aims to slash new HIV infections by 80 percent by 2025 through combination prevention, including scaling PrEP to 90 percent coverage among high-risk groups like adolescent girls and young women (AGYW), female sex workers and men who have sex with men.

The plan explicitly calls for innovative long-acting biomedical tools to boost adherence, challenges that have limited oral PrEP uptake, and positions such interventions as key to reaching vulnerable populations, mirroring Zimbabwe's prior swift adoption of cabotegravir injectables in 2022.

With new infections already down 73 percent since 2010, Lenacapavir supports the strategy's emphasis on equity, integration with sexual and reproductive health services, and domestic financing via the AIDS levy to sustain progress toward UNAIDS 95-95-95 goals.

The approval places Zimbabwe among a growing list of countries rolling out the breakthrough drug, which boasts near-100 percent efficacy in clinical trials and has been hailed as a potential game-changer in curbing new HIV infections.

The US Food and Drug Administration (FDA) greenlit Lenacapavir for PrEP in June 2025, followed by European Commission authorisation in August.

The World Health Organization (WHO) issued guidelines endorsing its use just weeks later in July, urging global adoption to meet 2030 targets for ending AIDS as a public health threat.

To date, Zambia and South Africa have also approved the injectable, with first shipments arriving in sub-Saharan Africa this month under a partnership involving Gilead, the Bill & Melinda Gates Foundation and the Joint United Nations Programme on HIV/AIDS.

Gilead has pledged to file for regulatory approval in at least 18 high-burden countries by year-end, including Botswana, Ethiopia, Kenya, Malawi, Nigeria, Tanzania and Uganda, representing about 70 percent of global HIV cases outside the US and Europe.

The company has committed to affordable pricing in low-income nations, aiming for broad access by 2027 through voluntary licensing and generic manufacturing deals.

MCAZ used a regulatory reliance pathway, leaning heavily on the rigorous scientific assessment already completed by the WHO’s Prequalification programme, which allowed the unusually swift review.

With nearly 1.3 million people living with HIV in Zimbabwe, and an estimated rate of 0.17 percent new infections annually, mostly among young women and adolescent girls, campaigners have hailed the move as a potential turning point for prevention among groups who struggle with daily pill regimens, including sex workers and mobile populations.

Lenacapavir, already approved in several countries under the brand name Sunlenca (for treatment) and now as PrEP, is expected to become available in Zimbabwe in the coming months once pricing and distribution agreements are finalised.