From Clinical Trial Efficacy to Public Health Impact: A Plan for Accelerating Access to Injectable Lenacapavir for PrEP

This plan provides a broad view of all the moving parts and identifies actions and actors responsible for ensuring time is not wasted and opportunity not squandered.

The Lens on LEN

The Basics on Injectable Lenacapavir as PrEP

In 2024, Gilead Sciences released findings from the PURPOSE 1 and PURPOSE 2 trials testing lenacapavir (LEN) as HIV prevention. The PURPOSE 1 trial found 100% efficacy in preventing HIV in 5,300 cisgender women in Uganda and South Africa, and the PURPOSE 2 trial showed a 96% reduction in HIV incidence among cisgender men, trans, and non-binary individuals across multiple countries. Both trials demonstrated LEN’s safety and effectiveness in reducing HIV transmission. This advocates’ primer provides background on the product and trials; a summary of the early findings of PURPOSE 1 & 2; key questions and next steps.

Download the report.

Sexual and Reproductive Health Integration Advocacy Roadmap

This roadmap addresses the critical need for integrated sexual and reproductive health (SRH) and HIV services. This integration is essential for enhancing public health outcomes, socio-economic benefits, and individual health and rights. The Roadmap aims to revitalize and sustain advocacy efforts for SRH and HIV integration, empower communities to hold stakeholders accountable for implementation, increase political and program support to enable the shift from policy to practice, and foster dynamic partnerships across research, advocacy, implementation, and policy sectors.

It was developed by Copper Rose Zambia (CRZ) as part of the Coalition to Accelerate and Support Prevention Research (CASPR). It draws on extensive input, including desk reviews, interviews, focus group discussions, and a specialized workshop held at the 2023 International Conference on AIDS and STIs in Africa (ICASA).

PxWire Volume 14, Issue No. 3

PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research and development, implementation and advocacy. Each issue includes updates, emerging issues and upcoming events. A PDF version of this report is also available.

Progress in PrEP Uptake

Oral PrEP initiations in Uganda were among the highest in the region, with sizable increases each quarter, until the enactment of the Anti-Homosexuality Act (AHA) in March 2023. Since then, the number of new PrEP initiations plummeted, and have since struggled to sustain rates seen in 2023. Public policies clearly matter.

Among 134 countries reviewed, 42 have comprehensive anti-discrimination policies covering a broad range of populations, while 24 lack any such policies. The remaining countries have adopted partial measures. Nations with comprehensive anti-discrimination policies, document significantly higher rates of PrEP initiation compared to those without such protections. Key studies show a strong link between supportive policies (which can enable PrEP eligibility, HIV self-testing, and lower age of consent for treatment, for example) and higher PrEP initiations.

An analysis presented at AIDS 2024, HIV Pre-Exposure Prophylaxis Policies Worldwide, by the Georgetown University Center for Global Health Policy & Politics and AVAC found that 69% of the 194 countries reviewed have approved at least one PrEP product. However, only 52% of these countries adhere to WHO guidance on PrEP eligibility, with regulatory approvals and national policies that support PrEP use for all populations or people at risk. This data reinforces the critical need for policies that support PrEP uptake.

PrEParing for New Products

Advocacy to accelerate licensing for new products can speed the process of generics manufacturing.

Three generic manufacturers—Aurobindo, Cipla, and Viatris—have licenses via the Medicinces Patent Pool to develop generic versions of injectable cabotegravir (CAB) for PrEP. These generic products are currently in development and expected to be submitted to regulatory authorities in the second half of 2026, with possible approval in 2027.

Does the Timeline Have to be this Long?

As CAB for PrEP is a long-acting, extended-release injection, bioequivalence (BE) testing takes time to determine whether the generic drug functions in the body similarly to the original drug. As shown on the timeline graphic below, the BE study (as determined by WHO guidance) is the longest part of the development process for generic CAB. But other steps, such as selecting and licensing generic manufacturers and technology transfer could be done faster. It is critical that generic manufacturers for new PrEP products, such as lenacapavir, star as soon as possible. This requires Gilead to pursue licensing even before regulatory submission, and to accelerate technology transfer and API development.

Product Updates

  • Data from HPTN 084 show that CAB for PrEP was generally well tolerated and safe for both pregnant cisgender women and their babies.
  • China has approved CAB for PrEP.
  • With PEPFAR support, Eswatini, Nigeria, and Ukraine are poised to introduce CAB for PrEP into their national PrEP programmes this quarter, and the South African government announced CAB supplies from PEPFAR will be launched in Q1/Q2 2025.

See AVAC’s Planning Matrix for more!

The Latest R&D in the Prevention Pipeline

Results from the PURPOSE 1 trial of injectable lenacapavir showing 100% efficacy in preventing HIV among cisgender women and adolescent girls dominated headlines at the AIDS 2024 conference. This Phase 3 trial, conducted by Gilead Sciences, involved over 5,000 participants from South Africa and Uganda and demonstrated superior results compared to daily oral PrEP options. See the New England Journal of Medicine publication, accompanying Editorial and our advocates’ primer to learn more about the results and what needs to happen next: Lens on LEN: The basics on injectable lenacapavir as PrEP.

Gilead’s PURPOSE 2 Phase 3 trial is ongoing and testing injectable lenacapavir as PrEP in the US, South Africa, Peru, Brazil, Mexico, Argentina, and Thailand, among cisgender men who have sex with men, transgender women, transgender men, and gender non-binary individuals. With 3,000 participants enrolled, initial results are anticipated in late 2024 or early 2025. Two other trials (PURPOSE 3 & 4) are currently recruiting in the United States, enrolling cisgender women and people who inject drugs, respectively. Enrollment for PURPOSE 5 in France and the UK is expected to commence in the latter half of this year. For more information about the lenacapavir trials, visit: An Overview of Lenacapavir for PrEP Trials.

Meanwhile, the bioequivalence study for the Dual Prevention Pill (DPP), designed to prevent both HIV and pregnancy, has concluded successfully, with each of the drugs functioning together in the body in a similar way to how they function alone. The promising results pave the way for regulatory submission and potential large-scale adoption, offering another significant tool in the fight against HIV and unintended pregnancies. Learn more about the DPP and find resources for your advocacy.

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STI Watch Newsletter, July 2024

AVAC’s quarterly newsletter of the latest in STI vaccines, diagnostics, and other prevention tools and strategies

In the second quarter of this year, there have been exciting new reports and updates on guidelines that could help better inform our efforts and ultimately reduce STIs. In May, the World Health Organization (WHO) released a new report highlighting increasing STI incidence rates globally. This report notes that syphilis, gonorrhea, chlamydia, and trichomoniasis account for more than one million infections daily. It also showed an increase in multi-drug resistant gonorrhea, highlighting the need for diagnostics to properly detect and treat infections. Two weeks later, the U.S. Centers for Disease Control and Prevention (CDC) released much-needed clinical guidelines on the use of doxycycline postexposure prophylaxis (DoxyPEP) for STI prevention—and AVAC launched the Advocates’ Guide to DoxyPEP, a helpful tool in understanding the science to date and considerations for future research and implementation. While STI prevention and treatment options remain limited, these updates represent progress in understanding who is impacted by STIs and developing interventions to meet their needs. 

STI Advocacy Updates

In October, AVAC awarded funding to seven advocacy partners in Southern and East Africa to identify and share needs for STI prevention in their communities. Partners presented this work to a global audience, which is helping to build an advocacy agenda to accelerate development of new STI vaccines, diagnostics, and other prevention tools and strategies. In June, AVAC provided additional funding to support the ongoing STI work of these partners. Lookout for additional details about their progress in the coming months.

With syphilis and congenital syphilis rising in many countries, AVAC is following the work of Healthy Futures Global, a non-profit focused on the prevention of vertical transmission of syphilis. They are partnering with the Philippine Department of Health to understand how best to implement testing for HIV and syphilis in pregnancy with the ultimate goal of testing all pregnant Filipinas for HIV and syphilis. Subscribe to their newsletter here. 

Upcoming Events

  • STI International Exchange (STIIX) Virtual Conference Series
    July 12, 2024
    In this virtual conference series STIIX will explore inequalities in sexual health and HIV across the United States and how to improve access to services for vulnerable communities. Registration is free and open to all.
  • AIDS 2024 Preconference: Mobilize for Action on Sexually Transmitted Infections!
    July 21, 2024
    The WHO, International AIDS Society (IAS), and International Union Against STIs (IUSTI) will host a pre-conference session during AIDS 2024 to explore pressing issues in STI prevention, testing, and treatment options. AVAC Senior Program Manager for STIs, Dr. Alison Footman, and AVAC Executive Director, Mitchell Warren, will speak at the pre-conference. In person and virtual participation are available if you are registered for AIDS 2024.
  • National Sexual Health Conference
    July 30-31, 2024
    This virtual conference creates opportunities to share information, efforts, research, and best practices related to sexual health across the lifespan.
  • IUSTI + STI Prevention
    September 16-20, 2024 Registration is now open for two important STI conferences in September – which unfortunately are running concurrently in different parts of the world!

    The 2024 STI Prevention Conference will bring 1,200 conference attendees to Atlanta, Georgia, from September 16-19, 2024. Abstracts are being accepted until March 29.

    The 25th IUSTI World Congress will take place September 17-20, 2024, in Sydney, Australia, and provide an opportunity to meet, discuss and learn about the latest research and innovation in sexual and reproductive health.
  • National Coalition for Sexual Health (NCSH) Annual Meeting
    September 26, 2024
    The virtual NCSH Annual Meeting will include two panels: 1. Overcoming Obstacles: Sexual Health Censorship and Misinformation on Social Media and 2. Increasing the Appeal of STI Prevention Tools: Both Old and the New, and a Q&A session with a leader from the Division of STD Prevention, CDC.

New Resources

Doxycycline, an oral antibiotic, can be used as a post-exposure prophylaxis, commonly referred to as DoxyPEP, when used to prevent the acquisition of some bacterial STIs after sex. Doxycycline is inexpensive, easily tolerated, and widely available. However, questions remain regarding who will benefit most from DoxyPEP and how to implement this strategy broadly to ensure equitable access and minimize antimicrobial resistance. This guide seeks to explore and address these critical questions. 

Webinar & Event Recordings

What We’re Reading

  • Dual Epidemics: Leveraging HIV Infrastructure to Support HPV prevention, Testing, and Cervical Cancer Elimination Goals. This policy brief explores the challenges in treatment, prevention and care of those affected by HIV and human papilloma virus (HPV), and the opportunities for integrated funding and service delivery to galvanize the attention and support needed to improve lives.  
  • Syphilis Has Surged for Reasons That Go Beyond the Pathogen That Causes It. This perspectives piece highlights the rising rates of syphilis and congenital syphilis cases. Data from 2022 showed that lack of timely testing and adequate treatment contributed to 88% of congenital syphilis cases in the U.S. Additionally, fewer people have a primary care clinician and are seeking care in emergency departments, where syphilis testing capabilities are limited. There is need for a more comprehensive, syndemic-based, and strategic approach that includes addressing social determinants of health to help better detect and treat syphilis cases. 
  • Gaps in the prevention of mother-to-child transmission of syphilis: a review of reported cases, South Africa, January 2020–June 2022. Within this study, authors found that syphilis testing and treatment among pregnant women in South Africa fell short of WHO’s congenital syphilis elimination goal where more than 95% of pregnant women receive at least one antenatal visit, more than 95% of pregnant women are tested for syphilis, and more than 95% of pregnant women with syphilis receive treatment. Barriers to syphilis treatment included presenting late to antenatal care and delays in receiving syphilis test results. On-site, rapid syphilis testing has shown to decrease treatment delays, especially in settings with limited laboratory facilities. 
  • Millions of Girls in Africa Will Miss HPV Shots After Merck Production Problem. Merck will deliver only 18.8 million of the 29.6 million doses it was contracted to deliver in 2024 to low- and middle-income countries (LMICs) after a manufacturing disruption. While Merck plans to deliver delayed doses in 2025, this continues to delay implementation of HPV vaccines in LMICs that have waited years to begin vaccinating adolescent girls against HPV, the leading cause of cervical cancer. 

To learn more about AVAC’s STI Program, visit STIWatch.org and avac.org/sti. Email [email protected] for questions or additional information. And to sign up for specific updates on STIs, click here.

PxWire Volume 14, Issue No. 2

A Quarterly Update on HIV Prevention Research

PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research and development, implementation and advocacy. Each issue includes updates, emerging issues and upcoming events. A PDF version of this report is also available.

Progress in PrEP Uptake

New research provides reassuring evidence that oral PrEP can reliably prevent HIV infection in cisgender women even with non-perfect adherence. Prior to becoming the director of NIAID, Dr. Jeanne Marrazzo led a team in a study assessing the effectiveness of F/TDF for PrEP (brand name Truvada) among cisgender women across a wide range (11) of studies. This paper—HIV Preexposure Prophylaxis with Emtricitabine and Tenofovir Disoproxil Fumarate Among Cisgender Women, which she also presented on a recent Choice Agenda webinar—dramatically shifts the conversation away from the need for women to be “super-adherers” to oral PrEP. The data also reinforce the need to support an array of options for women.

These graphics show the very high effectiveness of oral F/TDF for women with daily adherence and also for those who had consistently high adherence. Data comes from 11 demonstration projects of 2,954 cisgender women across six countries (Botswana, India, Kenya, South Africa, Uganda, USA) over eight years (2012-2020).

The data also demonstrates comparable effectiveness of F/TDF found in cisgender men who have sex with men (MSM).

Global and Country Milestones

January-March 2024

  • Global cumulative PrEP initiations surpassed 6.7 million, which includes CAB initiations (12,075) and DVR initiations (1,797).
  • Mexico and the United Arab Emirates approved oral F/TAF (or Descovy) in April.

For more comprehensive PrEP initiation data, see our tracker, data.prepwatch.org.

PrEParing for New Products

It has taken over a decade from positive efficacy results for daily oral TDF/ FTC to reach scale globally—and six years post-efficacy just to become available, in limited quantities, in lower-and middle-income countries (LMIC). During this time, nearly 20 million people acquired HIV. How many of those infections would have been prevented with faster, more efficient rollout of PrEP?

The rollout of oral PrEP demonstrates that people don’t take PrEP simply because it’s available—there needs to be a demand for it, and it needs to be accessible, acceptable and used effectively by those who need and want it. These are the lessons the field is applying to the rollout of the dapivirine vaginal ring (DVR) and injectable cabotegravir for PrEP. To reach the UNAIDS target of 10 million PrEP users by 2025, initiations of oral PrEP alone will not be enough—and the graphic at right does show that the field is beginning to apply past lessons to accelerate introduction of injectable cabotegravir.

Having multiple options for users to choose from is critical to increasing PrEP coverage, as seen from the early results of the SEARCH dynamic choice study, where coverage among participants featured a choice of products and settings for receiving oral PrEP, PEP, or injectable cabotegravir. The study showed 70% PrEP coverage in contrast with 13% coverage among those only offered oral PrEP or PEP from standard programs.

Product Updates

  • So far this year, Canada, Mozambique, Tanzania, and the United Kingdom approved injectable cabotegravir, and it’s now under review in Taiwan.
  • Malawi, Zambia and Zimbabwe are the second, third and fourth countries now rolling out injectable CAB outside the planned and ongoing implementation science studies. This is due to initial quantities supplied via PEPFAR.

See AVAC’s integrated study tracker for more at prepwatch.org/resources/product-introduction-country-planning-matrix.

The Latest R&D in the Prevention Pipeline

The PURPOSE efficacy trials are expected to report results later this year or in early 2025. If the six-monthly injectable lenacapavir demonstrates safety and efficacy, it will be the next long-acting injectable PrEP option to enter the market—and it is not too early to plan.

[UPDATE] June 2024: Read our blog post with the latest news, Landmark Trial in South Africa and Uganda Finds Twice Yearly HIV Prevention Injection Safe and Highly Effective

  • PURPOSE 1 is evaluating the safety and efficacy of both twice-yearly injectable lenacapavir and daily oral F/TAF in cisgender women in South Africa and Uganda.
  • PURPOSE 2 is assessing injectable lenacapavir among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States.
  • PURPOSE 3 is studying injectable lenacapavir for PrEP among cisgender women in the United States who are disproportionately affected by HIV, with a focus on Black women and other women of color.
  • PURPOSE 4 is evaluating injectable lenacapavir in adults who inject drugs in the United States.
  • PURPOSE 5 will evaluate injectable lenacapavir compared to F/TDF in people who may benefit from PrEP but who are not currently taking PrEP in Europe. The study has an intentional focus on recruiting participants from groups across France and the United Kingdom that are disproportionally affected by HIV and often underrepresented in clinical trials.

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For Us by Us: PrEP in Black America – A Master Plan for HIV Prevention in Black America

In the spirit of seeking change to ameliorate the devastating impact of HIV in Black communities through biomedical HIV prevention, Black leaders convened the “PrEP in Black America (PIBA) Summit” virtually and in person on September 13, 2022, in Atlanta, Georgia. Attendees have included Black activists, researchers, scientists, providers, and policymakers from across the country representing more than 50 organizations. Following the event, PIBA generated a report summarizing the event and key recommendations entitled, “For Us by Us: PrEP in Black America – A Master Plan for HIV Prevention in Black America.”

Read the full report, “For Us by Us: PrEP in Black America – A Master Plan for HIV Prevention in Black America” here.

STIWatch Newsletter, March 2024

The first quarter of 2024 ends with new research and questions on the future directions of STI vaccines and diagnostics. The Conference on Retroviruses and Opportunistic Infections (CROI) was the setting for positive news on the potential for early use of doxycycline to prevent STIs (DoxyPEP) in real-world settings and questions about its effectiveness in cisgender women given major evidence gaps. Important discussions and debates continued around the issue of antimicrobial resistance (AMR), as the field continues to grapple with the rollout of DoxyPEP. Presentations at CROI also highlighted the need for new diagnostics for syphilis as infections continue to increase globally and the need for STI advocacy efforts to ensure these infections get the attention and funding needed to develop vaccines and diagnostics that can prevent, detect, and treat these infections!    

In January, the US Centers for Disease Control and Prevention (CDC) released the STI surveillance data from 2022, which showed an increase in chlamydia and syphilis cases from 2021. Gonorrhea cases decreased between 2021 and 2022 by 9%. Alarmingly, 2022 congenital syphilis cases increased by 30% from 2021, signaling an urgent need for novel prevention, treatment, and testing methods.  

In Australia, a group of researchers published a response to the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine’s October 2023 statement on the use of DoxyPEP in Australia. The authors point to the potential threat of increasing AMR and the urgent need to implement measures to monitor DoxyPEP use and its impact.  

Read on for upcoming webinars, must-read resources supporting advocacy for improved funding and commitments for STI vaccines and diagnostics. Afterwards, test your knowledge with AVAC’s new STI Trivia quiz.  

New Report! STIs: A Review of the 2022 Vaccine and Diagnostic R&D Pipeline and Investments 

STI Vaccine and Diagnostic R&D Funding by Pathogen

A new AVAC report tracks funding trends in vaccine and diagnostics R&D, and pipeline investments for some of the most common STIs, including chlamydia, genital herpes, gonorrhea, hepatitis B, human papillomavirus (HPV), syphilis, and trichomoniasis. The report finds that STI research remains underfunded and neglected compared to other infectious diseases. Read the report to learn more.

STI Advocacy Updates

AVAC spoke with two cervical cancer advocates, Tamika Felder and Karen Nakawala, in January as part of its cervical cancer webinar series. Felder and Nakawala are breaking taboos and saving lives by empowering people to share their stories of survivorship and senseless loss. 

Felder, founder of Cervivor, Inc., was diagnosed with cervical cancer at 25, and turned her struggle into a mission, providing resources and a platform for those affected by the disease. Her impactful work and advocacy inspired Nakawala to found the Teal Sisters Foundation in 2020, following her successful treatment for cervical cancer. To learn more about Tamika and Karen, watch AVACs cervical cancer webinar. Thank you, Tamika and Karen for all that you do!  

January 18 marked HPV Awareness Day. AVAC and TogetHER for Health released an updated call to action to improve HPV vaccination among people living with HIV. In total, 31 organizations signed on to this call, urging global leadership to increase access to lifesaving HPV vaccines for people living with HIV.

Upcoming Events

STI Awareness Week is April 14 – 20!

Join us for two webinars focused on syphilis and DoxyPEP. These webinars are intended for health care providers, civil society organizations, public health officials, and others working in the STI/HIV fields. 

September 2024 STI Conferences

REGISTRATION IS NOW OPEN FOR TWO IMPORTANT STI CONFERENCES IN SEPTEMBER – WHICH UNFORTUNATELY ARE RUNNING CONCURRENTLY IN DIFFERENT PARTS OF THE WORLD!

The  2024 STI Prevention Conference will bring 1,200 conference attendees to Atlanta, Georgia, from September 16-19, 2024. Abstracts are being accepted until March 29. 

The  25th IUSTI World Congress  will take place September 17-20, 2024, in Sydney, Australia, and provide an opportunity to meet, discuss and learn about the latest research and innovation in sexual and reproductive health.  

What We’re Reading and Resources

  • Testing, testing: the advancing diagnostics for sexually transmitted infections. Diagnostics are urgently needed to detect STIs and this article examines several that are on the horizon. A US-Based company, Qvin is developing the Q-pad, a diagnostic menstrual pad with a removable strip to identify signs of diabetes and symptoms of high-risk human papillomavirus. Daye, a UK based gynecological start-up, launched a diagnostic product that is a tampon with the ability to screen for STIs. These advancements are exciting and serve as a reminder that advocacy is needed to ensure these products get to the people who need them. 
  • CARB-X Funds Visyby Medical to Develop a portable rapid diagnostic for Gonorrhea Including Antibiotic Susceptibility Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award up to US$1.8 million to biotechnology company, Visby Medical, to develop a portable rapid polymerase chain reaction (PCR) diagnostic to detect gonorrhea and its susceptibility to ciprofloxacin, a former frontline oral antibiotic that can no longer treat gonorrhea infections resistant to this medication. Funding will also support development of a test for gonorrhea, chlamydia, and trichomoniasis in men based on urine samples.
  • Syphilis Complicating Pregnancy and Congenital Syphilis. This manuscript provides a review of syphilis during pregnancy and congenital syphilis. As syphilis and congenital syphilis infections continue to rise, novel approaches are needed to detect, prevent, and treat infections. Because syphilis disproportionately affects populations with limited access to healthcare, new and improved diagnostics and therapeutics will need to be embedded within a health framework that prioritizes equity to improve the diagnosis and treatment of congenital syphilis, a preventable disease.  
  • Near-to-patient-testing to inform targeted antibiotic use for sexually transmitted infections in a public sexual health clinic: the NEPTUNE cohort study. This study examines the effectiveness of a novel lateral flow assay for point-of-care detection of gonorrhea among people with symptoms. Lateral flow assays are tests that can detect the presence of proteins or antigens for specific infections, like COVID-19 and HIV. This test had excellent clinical sensitivity and specificity in detecting gonorrhea among male and female patients with symptoms. A test like this could provide an important tool to better detect infections in settings without direct access to laboratory testing and reduce overtreatment.
  • Breaking Barriers in STI Clinical Management: Addressing Resistance Challenges and Incorporating New Diagnostic Approaches. This on-demand webinar features Dr. Van Der Pol and Dr. William Geisler who share their insights on crucial aspects of STI clinical management, focusing on resistance challenges and new diagnostic approaches. 

To learn more about AVAC’s STI Program, visit STIWatch.org and avac.org/sti. Email [email protected] for questions or additional information. And to sign up for specific updates on STIs, click here.

Developments in the HIV Biomedical Prevention Pipeline & PrEP Implementation Issues

An Update for Community Educators and Advocates

The European AIDS Treatment Group published a report covering two online discussions on the HIV biomedical prevention research & PrEP implementation issues for community educators and advocates. The report covers developments from the PREVENIR Cohort study, on long-Acting intramuscular PrEP, DoxyPEP, vaccine, as well as STI-PEP research. It also reviews challenges in the uptake of PrEP among women and in particular migrant women from sub-Saharan Africa and trans people.

Download the report. For more information and to see the recordings of the online discussions, click here.

PxWire Volume 14, Issue No. 1

A Quarterly Update on HIV Prevention Research

PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research and development, implementation and advocacy. Each issue includes updates, emerging issues and upcoming events. A PDF version of this report is also available.

Progress in PrEP Uptake

In 2020, the world missed the UNAIDS’ goal of reaching 3 million PrEP users. The updated target for 2025 is 10 million. Is the 2025 target achievable based on the current trends in PrEP uptake? Applying an Autoregressive Integrated Moving Averages (ARIMA) model to data from the Global PrEP Tracker since Q3 2016, we forecasted cumulative PrEP initiations through 2025. Based on this model, the world will surpass 10 million global cumulative PrEP initiations by Q1 2025, and by Q4 it will reach 12.4 million. This data reflects oral PrEP initiations, not continued use.

  • PrEP users and PrEP initiations are different. Data on initiations do not distinguish between new versus repeat PrEP users. We are unable to predict if the UNAIDS goal of achieving 10 million PrEP users by 2025 will be successful. This forecast shows the possibility and the promise of current momentum. But fulfilling this promise is not certain. It depends on overcoming key challenges around access and choice.
  • These updates from AVAC’s Global PrEP Tracker analyze trends and showcase data reflecting Q4 2023 updates.

Global Milestones from October-December 2023

  • The PrEP Tracker documented 6,220,507 cumulative initiations of some form of PrEP worldwide: 6,216,310 oral PrEP (including TDF/FTC, event-driven oral PrEP, and F/TAF), 2,695 injectable cabotegravir (injectable CAB), and 1,502 dapivirine vaginal ring (DVR).
  • Global PrEP uptake increased by about 500,000 PrEP initiations this quarter, modestly slower than in the last two quarters. Last year at this time, global PrEP initiations stood at 3.8 million, so this year’s increase demonstrates relatively high uptake compared to the previous year.

Country-level Milestones

  • South Africa surpassed 1.3 million oral PrEP initiations; Zimbabwe surpassed 250,000 initiations. In less than a year, Malawi more than doubled its oral PrEP initiations and now stands at over 100,000. Rwanda surpassed 30,000, Cote d’Ivoire surpassed 20,000, and Sierra Leone surpassed 10,000 initiations.
  • Other countries outside of Africa had modest increases in oral PrEP uptake: Brazil counted over 150,000 initiations; the Philippines surpassed 20,000 initiations.

PrEParing for New Products

Product Updates

  • In February, Zambia launched its injectable CAB program, making it the first country outside the US to include injectable CAB in its HIV prevention services. And the Desmond Tutu Health Foundation in South Africa also announced “the first jab” of injectable CAB administered in its FASTPrEP study. As these programs get underway, more country approvals and product launches are anticipated.
  • This quarter, Namibia approved the dapivirine vaginal ring (DVR), bringing the total to 11 approvals in the region.
  • Uruguay approved F/TAF (Descovy). Additionally, Descovy is under review in Mexico.
  • Peru, Nigeria, Thailand, and Uganda have approved injectable CAB.
  • Injectable CAB is under review in the United Kingdom, Cote d’Ivoire, Mozambique, Rwanda, Tanzania, and Canada. CAB was granted WHO prequalification status, finding it to be safe, effective, and supported by studies.
  • PrEPWatch added 35 new country pages detailing the status of drug registration for PrEP products, data on PrEP initiation by product, country-level PEPFAR targets, and links to key policy documents and guidelines.
  • At ICASA, the Population Council presented preliminary results from a dual prevention pill (DPP) acceptability study with adolescent girls and young women (AGYW) in Zimbabwe. The study found 2/3 of participants preferred a proxy for the DPP (which combines contraceptives and PrEP) compared to 1/3 who preferred taking oral PrEP and oral contraceptive pills separately. Results from another DPP acceptability study in South Africa are forthcoming and the HPTN 104 study is expected to kick off later this year, expanding the evidence on end-user experiences.
  • Alongside oral PrEP, introduction of the dapivirine vaginal ring (DVR) and injectable cabotegravir (CAB) will play a role in the scale of PrEP uptake. At least 1.2 million vials of CAB are now available for procurement and prevention programming in low-and middle-income countries over the next two years. At the same time, one million vaginal rings are projected to be distributed over the next two years. But even with these additional options, oral PrEP will continue to play a big role in PrEP uptake in the short term.
  • For a full global perspective on product introduction, check out the Integrated Study Tracker and Country Planning Matrix and see our graphic on the status of implementation scient studies on the next page.

The Latest R&D in the Prevention Pipeline

In 20 years of research and across 12 trials, only two positive signals have been observed in HIV vaccine and antibody studies.

  • In December 2023, the PrEPVacc team announced no efficacy from the vaccine candidates in the study. This was folowing a review by the independent data monitoring committee. PrEP interventions in the study, comparing TAF/FTC (Descovy) to TDF/FTC (Truvada) will continue. The termination of vaccine arms of the PrEPVacc study represents the most recent HIV vaccine or antibody trial to end without efficacy.
  • Ensuring equitable access to safe, effective, and affordable vaccines involves advocacy across multiple areas. AVAC covers the issues in a series of advocates’ guides, From the Lab to the Jab.

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