Table of Contents
- 1. European Commission Authorizes Twice-Yearly HIV Prevention Injection
- 2. A New era in HIV Prevention
- 3. Clinical Trial Results Demonstrate superior Efficacy
- 4. Global Expansion and Accessibility
- 5. Understanding HIV prevention: A Continuously Evolving Field
- 6. Frequently Asked Questions about Lenacapavir
- 7. What are the key mechanisms of action of cabotegravir and rilpivirine in combating HIV?
- 8. Revolutionizing HIV Management: EU Green Liberty’s First Treatment Set to be Administered Twice Annually
- 9. A New Era in HIV Treatment: Long-Acting Injectables
- 10. Understanding Green Liberty: Cabotegravir and Rilpivirine
- 11. Who is a Candidate for Green Liberty?
- 12. The Injection Schedule and Monitoring
- 13. benefits of Twice-Yearly HIV Treatment
- 14. Addressing Potential Concerns: Injection Site Reactions & Drug Interactions
Brussels, Belgium – August 26, 2025 – In a landmark decision, the European Commission has granted market authorization for Lenacapavir (Yeytuo®), a groundbreaking HIV prevention measure. This innovative therapy, administered as an injection just twice per year, is designated for adults and adolescents at increased risk of sexually acquired HIV-1 infection, weighing at least 35 kilograms.
A New era in HIV Prevention
The approval encompasses all 27 Member States of the European Union, alongside Norway, Iceland, and Liechtenstein. This decision follows an expedited review process by the Commitee for Medicinal Products for human Use (CHMP) of the European Medicines Agency (EMA),which highlighted the meaningful public health benefit of a twice-yearly administration schedule for this preventative treatment. The European Commission has also granted Lenacapavir an additional year of market exclusivity, recognizing its significant clinical advantages over existing therapies.
The World Health organization (WHO) endorsed Lenacapavir in July, recommending it as an additional prevention option for individuals at risk of HIV. according to experts, approximately 25,000 new HIV diagnoses occur annually in Europe, underscoring the need for more effective prevention strategies, especially among vulnerable populations. Jean-Michel Molina, a Professor of Infectious diseases at université Paris Cité, believes that this new, highly effective option could dramatically reduce new infections and propel Europe closer to eliminating the HIV epidemic.
Clinical Trial Results Demonstrate superior Efficacy
the authorization is based on data from the Phase 3 Purpose 1 and Purpose 2 trials conducted by Gilead. These studies demonstrated a 100% reduction in HIV infections and superior prevention rates compared to daily oral PrEP (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg).
In the Purpose 2 study, involving a diverse group of cisgender men and transgender individuals, only two infections occurred among 2,179 participants receiving Lenacapavir subcutaneously every six months. This translates to a 99.9% HIV-free rate for participants. Both trials reported that Lenacapavir was generally well-tolerated, with no new or significant safety concerns identified. The findings were published in the prestigious ‘New England Journal of Medicine,’ and ‘Science’ magazine named Lenacapavir its ‘Breakthrough of the Year’ for 2024 in December.
Global Expansion and Accessibility
Beyond the United States and the European Union, Gilead is actively seeking regulatory review for this twice-yearly PrEP regimen in Australia, Brazil, Canada, South Africa, and Switzerland. Requests are also underway in Argentina, Mexico, and Peru.
Furthermore,the EU-M4All program,dedicated to Lenacapavir access,intends to submit applications to national regulatory authorities in low- and middle-income countries (LMICs),expediting review times through previously established licensing agreements.This initiative aims to make the treatment accessible in regions were it is needed most.
| Feature | Lenacapavir (Yeytuo®) | Daily Oral PrEP |
|---|---|---|
| Administration | Injection (twice yearly) | Oral tablet (daily) |
| Efficacy | 99.9% effective in trials | Highly effective with consistent use |
| Frequency | Every 6 months | Every day |
| Target Population | Adults & Adolescents ≥35kg at risk of HIV-1 | Adults & Adolescents at risk of HIV-1 |
Did You Know? The introduction of Lenacapavir represents a significant advancement in HIV prevention,possibly overcoming barriers to adherence associated with daily oral medication.
Pro Tip: Discuss all preventative options with your healthcare provider to determine the best approach for your individual circumstances and risk factors.
Understanding HIV prevention: A Continuously Evolving Field
The fight against HIV has seen remarkable progress, moving from a once-fatal disease to a manageable condition for many. The advancement of antiretroviral therapies (ART) has been crucial, allowing people living with HIV to live long and healthy lives. Prevention methods have also evolved considerably. Before Lenacapavir and daily oral PrEP, strategies focused on safe sex practices and testing. The availability of PrEP, first as a daily pill, marked a significant shift towards proactive prevention.Now, with Lenacapavir’s approval, individuals have another, potentially more convenient and effective, option to protect themselves. Ongoing research continues to explore new prevention strategies, including long-acting injectable formulations and even potential vaccines.
Frequently Asked Questions about Lenacapavir
- What is Lenacapavir? Lenacapavir is a new HIV prevention medicine given by injection.
- How often is Lenacapavir administered? This preventative option is administered as an injection only twice a year.
- Is Lenacapavir suitable for everyone? Lenacapavir is approved for adults and adolescents weighing at least 35 kg who are at risk of contracting HIV-1.
- How effective is Lenacapavir? Clinical trials showed a 99.9% efficacy in preventing HIV infection.
- Where is Lenacapavir available? Its currently approved in the European Union and the United States,with applications underway in other countries.
- What are the potential side effects of Lenacapavir? Studies indicate that Lenacapavir is well-tolerated,with no significant new safety concerns identified.
- Will Lenacapavir be available in low-income countries? Gilead is working to make Lenacapavir accessible in low- and middle-income countries through licensing agreements and expedited review processes.
What are your thoughts on this new HIV prevention option? Share your comments below and help us spread awareness!
What are the key mechanisms of action of cabotegravir and rilpivirine in combating HIV?
Revolutionizing HIV Management: EU Green Liberty’s First Treatment Set to be Administered Twice Annually
A New Era in HIV Treatment: Long-Acting Injectables
For decades, managing Human Immunodeficiency Virus (HIV) has centered around daily oral antiretroviral therapy (ART). While highly effective at suppressing the virus and preventing transmission, this daily regimen presents challenges for many individuals, impacting adherence and quality of life. now, a significant breakthrough is poised to change the landscape of HIV care: green Liberty, the first long-acting injectable ART regimen, approved for use in the European Union, administered just twice a year. This represents a paradigm shift in HIV treatment, offering a more convenient and discreet option for people living with HIV.
Understanding Green Liberty: Cabotegravir and Rilpivirine
Green Liberty combines two powerful antiretroviral drugs: cabotegravir and rilpivirine.These medications belong to classes known as integrase strand transfer inhibitors (INSTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs), respectively.
Cabotegravir: Works by preventing the HIV virus from integrating its genetic material into the host cell’s DNA.
Rilpivirine: Blocks the reverse transcriptase enzyme, crucial for HIV replication.
Administered as separate intramuscular injections, typically in the gluteal muscles, Green Liberty provides sustained drug release over an extended period. This eliminates the need for daily pills,substantially improving treatment adherence and reducing the pill burden associated with traditional ART. The formulation utilizes nanotechnology to create a slow-release depot injection.
Who is a Candidate for Green Liberty?
Not everyone with HIV is immediately eligible for Green Liberty. Current guidelines, based on clinical trial data, specify the following criteria:
- Virologically Suppressed: Patients must have a consistently undetectable viral load (less than 50 copies/mL) on a stable oral ART regimen for at least six months prior to switching.
- No History of ART Resistance: Individuals should not have documented resistance to either cabotegravir or rilpivirine. HIV drug resistance testing is crucial before initiation.
- stable Overall Health: Patients need to be generally healthy and able to tolerate intramuscular injections.
- Adherence History: While aiming to improve adherence, a history of good adherence to oral ART is generally preferred.
The Injection Schedule and Monitoring
The Green Liberty regimen involves an initial period of oral ART alongside the injections to ensure proper drug levels.
Month 1 & 2: Injections are given monthly, alongside continued oral ART.
Month 3 onwards: Injections are administered every two months.
Regular monitoring is essential. This includes:
Viral Load Checks: To confirm continued viral suppression.
Drug Level Monitoring: To ensure adequate drug concentrations are maintained. This is notably crucial in the initial phases of treatment.
Injection Site Reactions: Monitoring for any pain,redness,or swelling at the injection site. These are typically mild and resolve on their own.
benefits of Twice-Yearly HIV Treatment
The advantages of green Liberty extend beyond convenience.
Improved Adherence: Reduced dosing frequency directly translates to better adherence, a major factor in long-term viral suppression.
Enhanced Quality of Life: Eliminating daily pills reduces the stigma associated with HIV medication and offers greater freedom and discretion.
Potential for Reduced Side Effects: While side effects are similar to those seen with oral ART, some individuals may experience fewer due to the sustained release and reduced peak drug concentrations.
Discreet Treatment Option: The injectable format offers a level of privacy that daily oral medication cannot.
Reduced Pill Burden: Significantly lowers the number of pills a person needs to manage, simplifying their routine.
Addressing Potential Concerns: Injection Site Reactions & Drug Interactions
while Green Liberty is a significant advancement, it’s not without potential considerations.
Injection site Reactions: The most common side effects are injection site reactions,ranging from mild pain and tenderness to more noticeable swelling or redness. These are usually manageable and don’t require treatment discontinuation.
Drug Interactions: Cabotegravir and rilpivirine can interact with certain medications, including some antifungals, anticonvulsants, and
