Johannesburg, South Africa – A crucial multi-stakeholder roundtable is scheduled to commence this week, October 14-15, 2025, as South Africa prepares for the introduction of Lenacapavir, a novel approach to HIV prevention. The south african National AIDS Council (SANAC) and the Department of Health are jointly hosting the event.
What is Lenacapavir?
Table of Contents
- 1. What is Lenacapavir?
- 2. key Discussions at the Roundtable
- 3. Key Participants and Leadership
- 4. Understanding HIV Prevention: A Growing Landscape
- 5. Frequently Asked Questions About Lenacapavir
- 6. What strategies can be implemented to address the high cost of lenacapavir and ensure equitable access for all South Africans living with MDR-HIV?
- 7. Exploring Lenacapavir Access and Sustainability in South Africa: Insights from National Roundtable on 14-15 October
- 8. Current Landscape of HIV Treatment in South Africa
- 9. Lenacapavir: A Novel Treatment Option
- 10. Roundtable Discussions: Key Themes & Challenges
- 11. 1. Pricing and Procurement Strategies
- 12. 2. Diagnostic Capacity for Resistance Testing
- 13. 3. Healthcare Worker Training and Capacity Building
- 14. 4. Supply Chain Management and Logistics
Lenacapavir presents a meaningful advancement in HIV prevention. This long-acting antiretroviral medication is administered via injection only twice a year. Clinical Trials have demonstrated nearly complete protection against HIV infections when administered at six-month intervals. The treatment is already being utilized in the United States, Europe, and Canada for HIV treatment protocols. Now, attention is shifting towards its deployment in low- and middle-income nations, with South Africa at the forefront of this initiative.
key Discussions at the Roundtable
the two-day meeting will serve as a platform for diverse stakeholders – encompassing government agencies, the private sector, health regulators, development partners, funders, pharmaceutical companies, and civil society organizations – to tackle essential sustainability challenges. These include securing licensing agreements, ensuring adequate funding, guaranteeing access for all, addressing affordability concerns, expanding local manufacturing capabilities, identifying priority populations, and driving demand through public awareness campaigns.
A primary objective is to establish a clear pathway for obtaining a voluntary license for Lenacapavir and bolstering South Africa’s domestic pharmaceutical production capacity. According to UNAIDS, approximately 37.7 million people globally are living with HIV,underscoring the urgent need for innovative prevention strategies. UNAIDS Global HIV Statistics
Key Participants and Leadership
The roundtable will feature participation from key organizations, including the South African Health Products Regulatory Authority (SAHPRA), the Global Fund, the Gates Foundation, UNAIDS, and Gilead. Minister of Health, Dr. Aaron Motsoaledi, is scheduled to deliver the keynote address, emphasizing the government’s commitment to combating the HIV epidemic.
| Stakeholder | Role |
|---|---|
| SANAC & Department of Health | Event Hosts & Implementation Oversight |
| SAHPRA | Regulatory Approval & Safety monitoring |
| Global Fund & Gates Foundation | Financial Support & Program Funding |
| Gilead | Pharmaceutical Manufacturing & Supply |
| UNAIDS | Technical Guidance & Strategic Support |
Did You Know? Long-acting injectable HIV prevention methods can substantially improve adherence compared to daily oral medications.
Pro Tip: Increased investment in local pharmaceutical manufacturing can enhance accessibility and affordability of essential medicines in African nations.
The roundtable is scheduled to take place at the Protea Hotel OR Tambo,located at the Corner of York & Gladiator st,Rhodesfield,Kempton Park,commencing at 9:00 AM on both October 14th and 15th,2025.
What impact do you think this new prevention method will have on HIV rates in South Africa? And how significant is local manufacturing in ensuring equitable access to healthcare?
Understanding HIV Prevention: A Growing Landscape
The introduction of Lenacapavir is a part of a broader trend towards more effective and user-kind HIV prevention options. Pre-Exposure Prophylaxis (PrEP), taken as a daily pill, has been a cornerstone of prevention efforts for years.however, adherence can be a challenge. Long-acting injectables like Lenacapavir offer an choice that bypasses this issue, possibly reaching more individuals at risk. The WHO continues to endorse a combination of prevention methods tailored to individual needs and circumstances,including condom use,testing,and treatment as prevention. WHO on HIV/AIDS
Frequently Asked Questions About Lenacapavir
- What is Lenacapavir used for? Lenacapavir is a long-acting injectable medication used for HIV prevention, providing significant protection against infection.
- How often is Lenacapavir administered? It is administered via injection every six months.
- Is Lenacapavir currently available in South Africa? It is in the process of being introduced, with the roundtable addressing implementation strategies.
- Who will have access to Lenacapavir? Discussions at the roundtable will define priority populations for access.
- What are the key challenges to rolling out Lenacapavir? Key challenges include licensing, funding, affordability, and manufacturing capacity.
- What role does SAHPRA play in this process? SAHPRA is responsible for regulatory approval and ensuring the safety of Lenacapavir.
- Why is local manufacturing importent? Local Manufacturing will help with affordability and access.
Share your thoughts on this breaking news and join the conversation in the comments below!
What strategies can be implemented to address the high cost of lenacapavir and ensure equitable access for all South Africans living with MDR-HIV?
Exploring Lenacapavir Access and Sustainability in South Africa: Insights from National Roundtable on 14-15 October
Current Landscape of HIV Treatment in South Africa
South Africa carries a meaningful global burden of HIV, with ongoing efforts to achieve the UNAIDS 95-95-95 targets. while antiretroviral therapy (ART) has dramatically improved the lives of people living with HIV, challenges remain, especially for individuals with multi-drug resistant HIV (MDR-HIV). current treatment options for MDR-HIV are often limited, toxic, and expensive, creating a critical need for innovative therapies like lenacapavir.Understanding HIV drug resistance, antiretroviral therapy challenges, and the South African HIV epidemic is crucial to contextualizing the potential impact of lenacapavir.
Lenacapavir: A Novel Treatment Option
Lenacapavir represents a breakthrough in HIV treatment. ItS a first-in-class capsid inhibitor, meaning it disrupts a different stage of the HIV lifecycle than existing drugs. This unique mechanism of action makes it effective against viruses resistant to many commonly used ART medications. Key features include:
* High Barrier to Resistance: Lenacapavir’s structure makes it difficult for the virus to develop resistance quickly.
* Long-Acting Formulation: Available as both an oral and injectable formulation, offering flexibility in treatment regimens. The injectable form, administered subcutaneously, provides sustained drug levels, possibly improving adherence.
* Broad Spectrum activity: Effective against a wide range of HIV subtypes and resistance mutations.
* Potential for salvage Therapy: Offers a viable option for patients who have exhausted other treatment options.This is particularly relevant in the context of advanced HIV disease and treatment-experienced patients.
Roundtable Discussions: Key Themes & Challenges
The national roundtable held on october 14-15th focused on navigating the complexities of introducing and sustaining lenacapavir access in South Africa. Several key themes emerged:
1. Pricing and Procurement Strategies
The high cost of lenacapavir is a major barrier to access. Discussions centered on:
* Negotiating with the manufacturer (Gilead Sciences): Exploring tiered pricing models and voluntary licensing agreements.
* Pooled Procurement: Leveraging regional purchasing power to secure lower prices. This aligns with existing South African pharmaceutical procurement strategies.
* Local Manufacturing Potential: Investigating the feasibility of local production to reduce costs and enhance supply chain security.
* Health Technology Assessment (HTA): The role of HTA in justifying the cost-effectiveness of lenacapavir within the South African healthcare system.
2. Diagnostic Capacity for Resistance Testing
Accurate and timely HIV resistance testing is essential to identify patients who will benefit from lenacapavir. Challenges include:
* Limited Laboratory Infrastructure: Expanding access to genotypic resistance testing across all provinces.
* Turnaround Times: Reducing the time it takes to receive resistance test results.
* Quality Assurance: Ensuring the accuracy and reliability of resistance testing. Investing in HIV resistance testing infrastructure is paramount.
* Integration with National HIV Programs: Seamlessly incorporating resistance testing into routine HIV care.
3. Healthcare Worker Training and Capacity Building
Effective implementation requires a well-trained healthcare workforce.Focus areas include:
* Lenacapavir-Specific Training: Educating doctors, nurses, and pharmacists on the drug’s mechanism of action, administration, and potential side effects.
* MDR-HIV Management: Strengthening overall capacity for managing complex cases of MDR-HIV.
* Adherence Support: Providing counseling and support to patients to ensure adherence to treatment. This is especially important for the injectable formulation.
* Pharmacovigilance: Establishing robust systems for monitoring and reporting adverse events.
4. Supply Chain Management and Logistics
Ensuring a reliable supply of lenacapavir is critical. Considerations include:
* Cold Chain Management: Maintaining the appropriate temperature for storage and transportation.
* Inventory Control: Accur