Zimbabwe Approves Groundbreaking Twice-Yearly Anti-HIV Drug Lenacapavir

Zimbabwe approves Lenacapavir, a twice-yearly HIV prevention injection, marking a major step in PrEP access and strengthening national efforts to curb new infections (image source)

Zimbabwe Fast-Tracks Approval

The Medicines Control Authority of Zimbabwe (MCAZ) has granted expedited approval to Lenacapavir, a long-acting injectable PrEP medicine that prevents HIV-1 infection. The drug — the first twice-yearly HIV prevention injection — demonstrated over 99% effectiveness in global trials.

Gilead submitted the application on 29 October 2025, and approval was completed in just 23 days, reflecting the Authority’s commitment to rapid access for high-impact public health products.

How Lenacapavir Works

Lenacapavir is recommended for adults and adolescents weighing at least 35 kg who are HIV-negative and at substantial risk of infection.

It is given as a six-monthly subcutaneous injection, following an initiation phase of one injection plus oral tablets on Days 1 and 2.

MCAZ Director-General Richard Rukwata said the approval underscores the Authority’s dedication to ensuring timely access to safe, effective, high-quality medical products.

Regional Context and Regulatory Review

Zimbabwe becomes the latest African country to approve the drug after South Africa, Eswatini and Zambia.

MCAZ relied on scientific assessments from the WHO Prequalification programme, applying a regulatory reliance model to support an efficient review while maintaining rigorous standards of safety, efficacy and quality.

Implications for HIV Prevention

Lenacapavir introduces a long-acting alternative to daily oral PrEP, with potential to significantly enhance adherence and expand prevention options, especially for high-risk groups.

Zimbabwe is among ten countries selected for early rollout, through a partnership with the U.S. government, Gilead Sciences and the Global Fund.

Initial rollout will prioritise vulnerable groups, particularly pregnant and breastfeeding women, as part of efforts to prevent new infections and reduce mother-to-child transmission.

Zimbabwe’s HIV Situation

Zimbabwe records an estimated 17,000 new HIV infections annually, with the highest incidence among females aged 15–29.

Despite this, the country has achieved major progress, meeting the 95-95-95 UNAIDS targets for adults.

National HIV prevalence among people aged 15–49 has declined from 12.69% (2019) to 10.49% (2023).

Available prevention options alongside Lenacapavir include oral Truvada, CAB-LA (long-acting cabotegravir), the dapivirine vaginal ring, VMMC, and condom-based, behavioural and structural interventions.