Lenacapavir Launches in South Africa and Brazil: Advancing Long-Acting Antiretroviral Therapy for HIV Management

New HIV Prevention Drug, Lenacapavir, sees Rapid Global Rollout with Focus on Accessibility

Geneva, Switzerland – December 3, 2025 – A groundbreaking new HIV prevention drug, lenacapavir, is rapidly gaining traction globally, with a strong emphasis on ensuring access in low- and middle-income countries. While the U.S. FDA accepted new drug applications for twice-yearly lenacapavir in February 2025, ongoing implementation research and strategic partnerships are paving the way for broader availability, particularly in regions hardest hit by the HIV epidemic.

Lenacapavir,designed for preventative use,is currently investigational and not yet globally approved. However, momentum is building: South Africa registered the drug in record time in late October, followed by Zambia in November, with initial doses already delivered thru The Global Fund and PEPFAR. Broader rollout in early adopter countries is anticipated in early 2026.

A key driver of accessibility is a landmark pricing agreement announced in September between Unitaid, Wits RHI, the Clinton Health access Initiative (CHAI), and Dr. Reddy’s Laboratories. This agreement will manufacture generic lenacapavir for just $40 per person per year by 2027, significantly lowering the cost barrier for widespread adoption.

Implementation research, led by Fiocruz in Brazil and Wits RHI in South Africa, is crucial to optimizing rollout strategies. These studies, supported by gilead Sciences, Inc., focus on integrating lenacapavir into existing HIV and primary healthcare services. Researchers are exploring effective delivery models for diverse populations – including adolescent girls and young women, men who have sex with men, and transgender individuals – and developing training programs for healthcare workers. The Brazilian study is also leveraging mobile clinics and digital platforms to reach vulnerable populations and provide informed decision-making support.

“access is not only about making a medicine available, it’s about ensuring it is acceptable and trusted by the people who will use it,” stated Dr. Philippe Duneton, Executive Director of Unitaid. “By learning the most effective delivery models for each of the populations at high risk of HIV, including young women, we are providing countries with the evidence required for the most impactful lenacapavir rollout – and getting the most out of every dollar invested.”

Beatriz Grinsztejn, President of the International AIDS Society and Director of the HIV/AIDS Clinical research Laboratory at Fiocruz, added, “This study… helps us understand what it takes for lenacapavir to fit into daily life and truly expand choices in HIV prevention. The lessons we gain in Brazil will help improve access both here and across Latin America.”

These collaborative efforts represent a notable step towards ending the HIV epidemic by ensuring that innovative prevention tools reach those who need them most, sustainably and effectively. unitaid remains dedicated to

What are the key benefits of lenacapavir compared to customary ART regimens?

Expanding Access to Innovative HIV Treatment

The recent launch of lenacapavir in South Africa and Brazil marks a significant step forward in HIV management, offering a novel, long-acting antiretroviral therapy (ART) option. This advancement is especially crucial in regions heavily impacted by the HIV epidemic, where adherence to daily oral medications can be a substantial challenge. Lenacapavir, marketed as Sunlenca®, represents a new class of antiretroviral drugs – capsid inhibitors – and provides a much-needed alternative for individuals with multi-drug resistant HIV. This article will delve into the specifics of lenacapavir, its benefits, and the implications of its availability in these key African and South American nations.

Understanding Lenacapavir: A New Class of HIV Drugs

Lenacapavir distinguishes itself from traditional ART regimens through its unique mechanism of action. Unlike nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), or integrase inhibitors, lenacapavir targets the viral capsid – the protein shell that encloses the HIV genetic material.

Hear’s a breakdown of key features:

* Mechanism of action: Disrupts multiple stages of the HIV lifecycle by interfering with capsid assembly and disassembly.

* Long-Acting Formulation: Administered as a subcutaneous injection every six months, substantially reducing the burden of daily pill-taking.

* Potent Activity: Effective against a broad range of HIV subtypes, including those with resistance to other ART drugs.

* Novel Drug Class: First-in-class capsid inhibitor, offering a new target for HIV treatment.

This innovative approach is particularly valuable for individuals experiencing treatment failure due to drug resistance, a growing concern globally. The availability of lenacapavir expands the toolkit for managing complex HIV cases and improving patient outcomes.

Lenacapavir in South Africa: Addressing a Critical Need

South Africa carries the world’s largest HIV burden, with approximately 7.8 million people living with HIV in 2023. Access to effective ART is vital, but adherence remains a significant hurdle. the introduction of lenacapavir offers a solution for those facing challenges with daily oral medications.

Key considerations for South africa:

* Multi-Drug Resistance: High rates of drug resistance necessitate alternative treatment options like lenacapavir.

* Adherence Challenges: Long-acting injectable ART improves adherence, leading to better viral suppression.

* Healthcare Infrastructure: implementation requires training healthcare professionals in administering the injection and monitoring patients.

* cost and Accessibility: Ensuring affordability and equitable access across the country is paramount. Government initiatives and partnerships with pharmaceutical companies are crucial.

Brazil’s Response: Integrating Lenacapavir into National HIV Programs

Brazil has a long-standing commitment to global access to HIV treatment.The country’s national HIV program is renowned for its comprehensive approach, including free ART for all citizens. The inclusion of lenacapavir strengthens this program by providing a new option for individuals with limited treatment choices.

Specific aspects of Brazil’s integration strategy:

1. National Health System (SUS): Lenacapavir will be incorporated into the SUS, ensuring widespread availability.
2. targeted Patient Population: Initially,the drug will be prioritized for individuals with multi-drug resistant HIV who have tired other treatment options.
3. Monitoring and Evaluation: Robust monitoring systems will track treatment outcomes and identify any potential challenges.
4. Pharmacovigilance: Continuous monitoring for adverse events is essential to ensure patient safety.

Benefits of Long-Acting ART with Lenacapavir

The shift towards long-acting ART, exemplified by lenacapavir, offers numerous advantages over traditional daily oral regimens:

* Improved Adherence: Reduced dosing frequency minimizes the risk of missed doses, leading to better viral suppression.

* Enhanced Quality of Life: Eliminating the daily reminder of HIV infection can reduce stigma and improve mental well-being.

* Reduced Pill Burden: Simplifies treatment regimens, making them easier to manage.

* Potential for Reduced Drug Interactions: Less frequent dosing may minimize the risk of interactions with other medications.

* Discreet Treatment: Subcutaneous injections offer a more discreet treatment option compared to daily pills.

practical Considerations for Patients and Healthcare providers

Triumphant implementation of lenacapavir requires careful consideration of practical aspects:

* Patient Selection: appropriate patient selection is crucial. Individuals must have documented multi-drug resistant HIV and be willing to commit to the injection schedule.

* Injection Site Management: Healthcare providers must be trained in proper injection technique and management of potential injection site reactions.

* Monitoring for Adverse Events: Regular monitoring for adverse events, such as injection site reactions and hypersensitivity, is essential.

* patient Education: