Protecting Global Gains – HIV care and treatment innovations amid COVID-19

In this new edition of Protecting Global Gains, learn how an innovative approach to HIV care and treatment has helped Malawi better weather the impact of COVID-19. This latest story comes in the lead up to World AIDS Day—with this year the world commemorating the fight against one pandemic in the midst of another. World AIDS Day also provides an opportunity to reflect on work to protect hard-won gains against HIV during a global public health crisis.

In Malawi, people who have been taking HIV medication for at least six months and have a stable viral load can take home a multi-month supply of medications, which reduces the need to travel to the clinic. This kind of differentiated service delivery (DSD) has proven to be an essential lifeline during COVID-19.

DSD models for treatment and prevention—teams of community health workers, mobile clinics, support networks and supply chains—will all be as critical to the fight against COVID-19 as they are to efforts to end AIDS. These are the systems and services that people already know and trust—and must be protected, sustained, and built upon to combat COVID-19, protect global health gains, and reimagine a brighter public health future.

In the short-term, advocates can demand policies and programs that make it easier for people to access health care, testing and treatment, for HIV and for COVID-19, and ensure that vulnerable and marginalized groups are included in decision-making.

Follow us on social media at @hivpxresearch, @theglobalfight and @Amref_Worldwide and #protectglobalgains, and consider amplifying these stories on your own social media. Visit to learn how to take action and to share your stories of innovation in the time of COVID.

Three Demands this World AIDS Day

World AIDS Day demands a lot of many of us. We must balance grief, worry and mourning with clarion calls to action and demands for accountability. On this day of private meaning and public mobilization, AVAC brings you a letter—to you, whoever and wherever you are, to all the leaders on the frontlines, in the halls of power and in the homes where caretaking and community mobilization happen. You can read our Letter to the World here.

In this letter, we’ve honed in on three things that feel essential to this present moment and the coming year:

1) Program for choice. For the first time in history, it is possible to build a choice-based biomedical HIV prevention program that offers a range of options. Today’s announcement that the World Health Organization has pre-qualified the Dapivirine Vaginal Ring brings this reality one step closer. But the full potential of choice-based programs depends on a client-centered, community-designed approach where people, not providers, decide what works for them.

2) Pay for the healthcare workforce to achieve health equity. From community contact tracers to counselors, community health workers, frontline nurses and physicians, it is essential to invest in well-paid, well-trained health workers who come from and have the trust of the communities hardest hit by health inequities.

3) Pursue just, equitable access for COVID-19 vaccines, therapeutics and community-led prevention. Each passing day brings news from COVID-19 vaccine trials, much of it highly encouraging. There is not a minute to lose in taking steps that guarantee new innovations—for COVID and HIV—will be available and affordable to all who need them.

Check out our full letter to learn more about how AVAC thinks these priorities can be achieved. And write us back——what do you care about and want to fight for? We’re here and listening and looking forward to continued advocacy together.

Protecting Global Gains—Partners in Health

With the prospect of a new US Presidential administration, it’s time to identify innovations in the US and overseas that can help fight COVID and improve public health. Our latest update of Protecting Global Gains is a reminder that low-income countries have the experience, wisdom and inclination toward innovation that can save lives in wealthier nations.

In the latest edition in our series, learn how the state of Massachusetts is working with Partners in Health (PIH) to apply lessons from PIH’s epidemic responses in places like Haiti, Rwanda and Sierra Leone to offer care and support to people in quarantine.

America’s profit-driven health system has long prioritized medical and clinical services, even though community-led and -based solutions are drivers of health. With guidance from PIH, Massachusetts has invested in a corps of caregivers who follow up with individuals isolating or in quarantine after COVID-19 contact tracing. Non-medical support such as food, medicine, cleaning supplies, rental assistance and legal advice is helping people remain at home, boosting the reach and impact of contact tracing.

Katie Bollbach, director of PIH’s newly created US Public Health Accompaniment Unit, describes the effort as “an inflection point to reconsider and reimagine the health systems we need for the future.”

This is just one example of community-centered public health that is making a difference. Learn about other interventions that are succeeding in protecting public health in the midst of COVID-19 from our series, Protecting Global Gains, a initiative we are implementing in partnership with Amref Health Africa and Friends of the Global Fight Against AIDS, TB and Malaria.

Follow us on social media at @hivpxresearch, @theglobalfight and @Amref_Worldwide and #protectglobalgains, and consider amplifying these stories on your own social media. Visit to learn how to take action and to share your stories of innovation in the time of COVID.

Why Exciting Results from Vaccine Research are Just the Beginning of Efforts to End COVID-19

By AVAC Executive Director Mitchell Warren and first appeared in Devex.

The news last week and again this week that at least two highly effective vaccines may be on the horizon is a welcome respite from the devastating impact of COVID-19 on global health. In under a year, SARS-CoV-2 has already caused more than 56 million infections and 1.3 million deaths.

Any true analysis of the pandemic’s toll, however, must go beyond those devastating numbers to include the impact of COVID-19 on childhood immunizations, sexual and reproductive health, noncommunicable disease programs and global efforts to reduce HIV, tuberculosis, malaria and countless other diseases. With HIV alone, COVID-19 has diminished access to critical prevention and treatment supplies such as condoms and antiretroviral drugs, shuttered clinics and reduced testing.

Now it appears that an intensive biomedical research effort is producing tools that could help to turn the COVID-19 pandemic around. This welcome and exciting news should be balanced by some important lessons from the HIV experience on the challenges of turning highly effective prevention tools into real and accessible options for people in need.

With HIV, a long-standing commitment to research that engages and respects the communities in which it is conducted has begun paying exceptional dividends in HIV prevention research, even in the midst of this new pandemic. The most recent of these is the success of long-acting cabotegravir injections in slowing HIV infections in both men and women — also big news this month.

Other recent advances include the positive European regulatory opinion on the dapivirine vaginal ring, a promising new HIV prevention option for women; the launch of the Mosaico HIV vaccine trial; and the upcoming release of data from AMP — meaning “antibody mediated prevention” — the first large-scale human study of HIV antibodies to reduce the risk of infection. On the user side, surprising increases in the uptake of PrEP, or preexposure prophylaxis, show that coronavirus-related access barriers are not enough to dampen demand for effective HIV prevention.

The decades of research and advocacy that led to these achievements in HIV provide important lessons for global responses to COVID-19 and other pandemics as well.

The first of these is that dedicated, collaborative, sustained and well-funded research can truly turn a pandemic around. Such an effort has produced treatments that allow people living with HIV to live full, healthy lives, along with a range of effective prevention strategies, including condoms, PrEP, clean needles, harm reduction and voluntary medical male circumcision.

The work to find, fund and ensure community-led delivery of these strategies has been long, challenging and resource-intensive — but it has also produced extraordinary results.

Another critical lesson: Complex health challenges defy simple, single-agent solutions. COVID-19 will not end by a vaccine alone. Instead, as with HIV, defeating this pandemic will require a harm reduction approach in which people have access to and are able to choose a combination of strategies that work for them, understanding that many tools reduce but do not necessarily eliminate risk.

Harm reduction can only work when it is supported by clear public health messages and freely available supplies — such as condoms, clean needles and PrEP for HIV, or masks, hand sanitizer and personal protective equipment for COVID-19. As both diseases show, inconsistent or politicized public health messaging, inequitable access to the options people need to protect themselves, and insufficient testing are only likely to heighten and prolong crises.

Ignoring the third lesson has prevented many countries from achieving epidemic control of HIV and threatens to do the same with COVID-19: Interventions that work beautifully in the lab or clinical trial can only have real-world impact if they respond to the needs of their intended users, are trusted by communities, and are readily available in a context free from stigma and discrimination.

The HIV experience shows that exceptional scientific progress is just one step in the complex effort to control a pandemic. Trust in biomedical products, and the willingness to use them, must be built on a foundation of participatory engagement throughout the research process.

That level of confidence may be challenging to achieve, however, in a COVID-19 response too often characterized by xenophobia, economic and racial discrimination and a highly politicized “warp speed” research and development effort, in which community engagement has been inconsistently prioritized.

Equally critical to sustained and effective pandemic responses is the need to build resilient health systems that proactively address and dismantle structural determinants of health.

Now is the time to develop bold visions of what universal health coverage can and must look like to ensure that health systems are shored up, revamped and redesigned to provide equitable access to a range of health services. As the Protecting Global Gains project has demonstrated, countries with flexible, resilient health systems, and an inclination toward innovation, are weathering both HIV and COVID-19 better than others.

While it may seem paradoxical, it is essential that as the world responds to COVID-19, it must also sustain and expand investments in HIV, TB, and malaria through funding mechanisms including the US President’s Emergency Plan for AIDS Relief and The Global Fund to Fight AIDS, Tuberculosis and Malaria, which are crucial sources of health system innovation.

Despite unprecedented prevention research progress, a new report by the Joint United Nations Programme on HIV/AIDS shows that 1.7 million people were newly infected with HIV last year — more than three times the global target of no more than 500,000 new infections annually by 2020.

Effective responses to COVID-19 and HIV will require a comprehensive, integrated and sustained commitment. As COVID-19 rightly consumes much of the world’s attention and global health resources in the year ahead, maintaining a clear focus on HIV, other serious health issues, and the responsiveness and effectiveness of health systems overall remains critical.

This hopeful moment in HIV prevention highlights how much we can learn from experience and underscores the imperative to develop and support resilient health systems that can fight multiple pandemics at once.

New Resources to Help Navigate the News on HIV and COVID-19

The latest news on R&D breakthroughs for prevention of COVID-19 and HIV brings to our lips this call: it’s time to be ready for action with dogged determination to demand transparency, accountability, evidence and equity. In case you missed it, AVAC has new resources to help prepare.

Long-Acting PrEP and the HIV Prevention Pipeline

HPTN 084 Primary Study Results Webinar – Download the HPTN webinar with trial leaders from HPTN 084 who discuss the primary results of HPTN 084.

Landmark Trial in East and Southern Africa Finds Injectable PrEP Safe and Effective for Cisgender Women – Read AVAC’s statement on HPTN 084’s efficacy findings and what must come next.

The Future of ARV-Based Prevention and Biomedical HIV Prevention Trials: Results, milestones and more – Check out the updates to our infographics on the HIV prevention pipeline.

HIV-Specific Neutralizing Antibodies by Target and Broadly Neutralizing Antibody Combinations – We’ve also updated these infographics on broadly neutralizing antibodies in HIV prevention research.

AMP-ticipation: Context and concepts for understanding the AMP Trials – Read this blog to prepare for the forthcoming results from the Antibody Mediated Prevention Study.

Protecting Global Gains – At this recently launched site, Amref Health Africa, AVAC and Friends of the Global Fight have come together to document the impact COVID-19 is having on global health programs and the innovative solutions that are being developed and implemented all over the world.

Global PrEP Tracker – This update of Q3 data shows overall global uptake continued to climb even in the midst of COVID-19. The number of people who have started on PrEP has reached 773,474, an increase of more than 23 percent since the year began.

The Promise and Challenge of PrEP for Adolescent Girls and Young Women – Listen to this podcast from our colleagues at CSIS, which includes perspectives from AVAC and Wits RHI.

Efficacy & Equity: Twin Powers to End Epidemics

Why exciting results from vaccine research are just the beginning of efforts to end COVID-19 – AVAC’s Mitchell Warren penned this Devex op-ed, pointing to important lessons from the field HIV on the steep but scalable challenges of turning highly effective prevention tools into real and accessible options for people in need.

Advocate’s Guide to COVID-19 Vaccine Access – A plain-language guide covering the necessary components for equitable COVID-19 vaccine access to help inform and support advocates.

Treatment Action Group and AVAC Statement on Pfizer/BioNTech COVID-19 Vaccine Efficacy Announcement – Read our statement with the Treatment Action Group (TAG) to learn more about what must come next to move forward with COVID-19 vaccines.

Efficacy News from Second COVID-19 Vaccine Trial Underscores Need for Transparency and Cooperation between Outgoing and Incoming US Administrations – Read this statement joint statement from AVAC and TAG to learn how and why US leaders must put people ahead of politics.

At AVAC, we’re watching for more COVID-19 vaccines that may soon join the two now showing efficacy, while our eyes remain firmly on HIV prevention options still in the pipeline. At the same time, no less focus is needed on programs and policies for equitable access. Use these resources to work with health leaders of all stripes to build the systems the world needs for prevention to become a reality everywhere it’s needed.

Efficacy News from Second COVID-19 Vaccine Trial Underscores Need for Transparency and Cooperation between Outgoing and Incoming US Administrations

Americans are dying. Politics cannot be allowed to slow vaccine roll out.

AVAC and Treatment Action Group (TAG) welcome today’s announcement that preliminary data from the efficacy trial of Moderna’s mRNA COVID-19 vaccine indicate a high-level of protection against COVID-19. This is much needed good news as the US and other countries continue to see dangerously rising rates of COVID-19. As our organizations expressed in a statement last week about the Pfizer mRNA vaccine news, caution is warranted in interpreting this preliminary information as we wait for additional data from Moderna and further actions from the US Food and Drug Administration (FDA) and other global regulatory authorities.

In light of these hopeful announcements, planning for distribution of both of these vaccines must be accelerated. In the US, that planning – and potentially the beginning of distribution – will span two presidential administrations. It is clear that on January 20, 2021, there will be a change in executive leadership, even while the election results have not been certified and the Trump campaign continues to baselessly contest the results through lawsuits in a number of states.

AVAC and TAG call on the Trump campaign and administration, senior elected officials in the Republican Party and the leadership of the Republican National Committee to put the lives of the American people ahead of politics and move to ensure that there is a smooth transition of power that focuses on transparency. The GOP must work hand in hand with the incoming Biden Administration to maximize the impact of the limited number of vaccine doses that are expected to be available late in 2020 and early 2021.

The Biden transition team has laid out plans for a comprehensive COVID response that give us hope that – especially with the deployment of highly effective vaccines where they are needed most – the pandemic may begin to be controlled in 2021. That work will be more effective and will save more American lives if the incoming administration has all possible information about stockpiles, distribution plans and other logistics along with the ability to meet with and work with current administration officials and state and local officials.

But there is also urgent work to be done by the current Congress and Administration. Deploying these vaccines will be one of the most ambitious public health undertakings in history. A comprehensive, fully-funded and nationally-directed deployment plan must be developed now to complement the billions of dollars invested and the time, talent and commitment of thousands of researchers and trial participants who gave us these results. Vaccine costs should reflect the significant contributions of public financing to their design and development. Congress must come together in a bipartisan way to ensure that the CDC and state and local health departments have the funding, technology, training and support needed to ensure that vaccines can be deployed as quickly as possible to reach the most at-risk populations, accompanied by appropriate, evidence-based and trusted public health information.

We have lost almost 250,000 Americans to this virus, and new infections are rising every day. It is past time to put American lives ahead of politics.

Advocate’s Guide to COVID-19 Vaccine Access

Bold, evidence-based activism and advocacy have shaped the HIV response for nearly 40 years. To help bring the same focus and power to COVID-19 vaccine advocacy, AVAC has developed the Advocate’s Guide to COVID-19 Vaccine Access.

Monday’s announcement that Pfizer/BioNTech’s mRNA COVID-19 vaccine showed high levels of effectiveness was great news. As AVAC and TAG said in a statement yesterday, it’s now key to confirm the data and, at the same time, to begin to plan for rapid, affordable and equitable access to this and other vaccines.

The Advocate’s Guide is a timely tool for building the movement to make this happen. It provides plain-language explanations of the necessary components for equitable access to help inform and support advocates. These critical elements include:

  • Adequate funding to the financing mechanisms supporting access: International development agencies should prioritize funding the COVAX Advance Market Commitment (AMC) to secure vaccine access for low and middle income countries (LMICs).
  • Equity in vaccine purchasing: Some wealthy countries are limiting the supply of vaccines available for LMICs by entering into direct agreements with vaccine developers to secure millions of doses for the exclusive use of their own citizens.
  • Pricing at low or no cost to all who need it: Fair pricing depends on transparency, and product developers must disclose development costs—both their own investments as well as the amounts received from public sector sources.
  • Equitable distribution: Distribution criteria must be clear, ethical, rights-based, and include metrics for ensuring vaccine access for prioritized populations.
  • Resilient health systems: Health systems and supply chains require national investments to prepare for the deployment of approved vaccines.

Advocates can demand that public health and human rights govern the eventual distribution of COVID-19 vaccines, not profits or politics. Initiatives to advance equitable access are already underway, such as the The People’s Pandemic Prevention Plan (of which AVAC is a supporter), the People’s Vaccine Alliance and the recent TRIPS waiver submitted by India and South Africa.

AIDS activists have a long history of building strong, specific, audacious access campaigns. As COVID-19 work continues, we’ll need to use those muscles to fight for global equity for COVID vaccines. AVAC looks forward to working with allies, including through the COVID Advocates Advisory Board (CAAB), to articulate specific campaigns focused on investments, legislation and more. And you can use the Guide to begin mapping strategy, identifying targets, and informing the following advocacy actions:

  • Review decisions that have been made or are under consideration where you live;
  • Formulate demands that are most relevant to your work; and
  • Find out who is working on access planning and how you can connect with them.

We look forward to hearing your feedback and to collaborating on advocacy for rapid, equitable access.

Treatment Action Group and AVAC Statement on Pfizer/BioNTech COVID-19 Vaccine Efficacy Announcement

Preliminary results suggest the strategy of immunizing with the SARS-CoV-2 spike protein is efficacious, but details are lacking, and the exact nature and duration of the effect is unclear.

Treatment Action Group (TAG) and AVAC welcome today’s announcement that preliminary data from the efficacy trial of Pfizer/BioNTech’s mRNA COVID-19 vaccine indicates a high-level of protection against COVID-19. Our organizations urge caution, however, given the very limited information that is available only through a company press release.

The manufacturers have reported that greater than 90 percent protection was observed in a preliminary, pre-scheduled assessment of confirmed COVID-19 cases that occurred at least seven days after trial participants received the second injection of the two-dose vaccine regimen. A total of 94 cases of confirmed COVID-19 were included in the analysis, suggesting that nine or fewer were among recipients of the vaccine.

The information was disclosed after an interim analysis by the trial’s Data Safety Monitoring Board (DSMB) and no further details or data were provided (according to reporting by STAT News, even the companies are not privy to additional information). No serious safety issues have been documented to date, but a thorough, independent review of all adverse events will be necessary prior to any marketing of the product. The DSMB has recommended that the trial continue as planned and the final efficacy analysis will be performed after 164 confirmed COVID-19 cases, which may become possible before the end of the year.

The US Food and Drug Administration (FDA) has requested at least two months of safety follow up after the second vaccination before considering an Emergency Use Authorization (EUA), and Pfizer’s CEO Albert Bourla said sufficient safety data to meet this requirement should be available by the third week of November. This is a bare minimum for any review, and TAG and AVAC call for these data to be evaluated by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) in December before any action is taken. At the recent VRBPAC meeting on October 22, several members expressed concerns about the implications of vaccine EUAs and suggested that expanded access programs would be a preferable means of providing emergency access prior to full approval.

The Pfizer/BioNTech vaccine is designed to induce immune responses against the SARS-CoV-2 spike protein, a strategy that is also employed by many other candidates that are in efficacy trials. This provides some cause for optimism that multiple other vaccines will prove efficacious.

However, many questions remain given the lack of details available. Pfizer/BioNTech must be maximally transparent in releasing full information and data sets from the trial as they become available. Among the issues that will need to be addressed:

  • The exact details of the numbers involved, endpoints analyzed, and statistical findings including confidence intervals and p-values;
  • Efficacy against the range of possible COVID-19 outcomes, from asymptomatic (but potentially transmissible) SARS-CoV-2 infections to severe COVID-19 disease;
  • Efficacy across diverse populations, particularly those most vulnerable to severe COVID-19 such as the elderly and those with health conditions that may make COVID-19 outcomes worse;
  • Efficacy in populations that have been omitted from most studies to date, including children and pregnant women;
  • Full characterization of the safety profile;
  • Identification of correlates of vaccine-induce immune protection (such as antibody responses);
  • Investigations into why vaccination did not work in the study participants who acquired COVID-19;
  • Duration of protection. Studies suggest that immunity to seasonal cold-causing coronaviruses is typically short-lived (~6 months to a year), and it will be important to conduct long-term follow up to learn whether regular re-vaccination may be necessary;
  • Equitable vaccine distribution in the United States and globally. Factors that will need to be considered include cost, pace of production, availability of supply, and logistical considerations such as refrigeration (the Pfizer/BioNTech mRNA vaccine needs to be stored at -80° C until just before administration);
  • Ensuring any EUA (if deemed more appropriate than expanded access by FDA) places specific requirements for continued data collection and clearly articulates the pathway and timeline for a full application for licensure; and,
  • Implications for efficacy trials of other candidates, given that it may become inappropriate for participants to continue to receive placebos if an effective vaccine is available.

Today’s news offers hope that it will be possible to quell the COVID-19 pandemic with vaccination campaigns backed by strong public health measures. However, the data are still preliminary, and a safe, effective, and equitably delivered vaccine will require a great deal more verified, peer-reviewed data and regulatory decisions. Once a vaccine is available, equitable access depends on political will in the form of evidence-based messages, fully funded vaccination campaigns in all countries and communities, and a globally coordinated effort to ensure that supply and demand reflect need, not greed or nationalist responses. TAG and AVAC support the call for a people’s vaccine to made universally available to all at no cost.

TAG and AVAC are heartened by the news of the incoming US administration’s plans for dealing with the COVID pandemic and commend them for the decision to rejoin the World Health Organization (WHO) as soon as possible. We urge them to join multilateral efforts to ensure equitable global allocation and distribution of COVID-19 vaccines. No country in the world, including the United States, will end this pandemic with isolationist responses. The fact that the first report of COVID-19 vaccine efficacy emerged from a collaboration between a German and US company (the former founded by Turkish immigrants; the latter founded by German immigrants) underscores this point.

Key Points for HIV Advocates on Pfizer Vaccine Announcement

HIV prevention advocates following COVID-19 vaccines got not one but two pieces of scientific news in the past two days—both as welcome as the US election results announced over the weekend. The HIV Prevention Trials Network announced that injectable long-acting cabotegravir (CAB-LA) provided high levels of protection among cisgender women at risk of HIV; and Pfizer announced high levels of protection in its COVID-19 vaccine candidate.

Two trials, two injections, one bottom line: A product doesn’t protect if it’s not available. While neither CAB-LA for cisgender women nor the COVID-19 vaccine have published peer-reviewed results—as they must—planning for licensure and access must start now. More details about CAB-LA are here, and join HPTN’s webinar on Friday, November 13 at 7am EST to learn more about the results.

Read TAG and AVAC’s statement on the Pfizer announcement and find our key messages below:

  • Pfizer’s early results are welcome news but they must be read cautiously as the information on the data is still limited and only available through a company press release.
  • Current data do not yet support Emergency Use Authorization (EUA), and certainly not licensure. The trial’s continuation is essential.
  • The US FDA has requested at least two months of safety follow up after the second vaccination before considering an EUA; this is a bare minimum for any regulatory review.
  • When available, these data need to be evaluated by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).
  • Any EUA should place specific requirements for continued data collection and clearly articulate the pathway and timeline for a full application for licensure.
  • The Pfizer/BioNTech vaccine is designed to induce immune responses against the SARS-CoV-2 spike protein, a strategy that is employed by most other candidates in efficacy trials; these early data provide some cause for optimism that multiple other vaccines may prove efficacious.

Resources for additional context on COVID-19 vaccines:

Use these resources and others to stay informed and connected. Together, let’s make our way to a safe and effective people’s vaccine against COVID-19 that the world can trust and use.

Landmark Trial in East and Southern Africa Finds Injectable PrEP Safe and Effective for Cisgender Women

Regulatory review and introduction plans must be accelerated

AVAC enthusiastically welcomes the news that another trial of the long-acting, injectable antiretroviral cabotegravir (CAB-LA) for HIV prevention for HIV pre-exposure prophylaxis (PrEP) has demonstrated safety and efficacy, this time among cisgender women. Today’s announcement from ViiV, the US National Institute of Allergy and Infectious Diseases (NIAID), and the HIV Prevention Trials Network (HPTN) is based on a scheduled review by an independent data and safety monitoring board (DSMB) of the HPTN 084 study. Data reviewed by the DSMB found that CAB-LA provided significant protection from HIV. The trial also re-confirmed the safety and efficacy of daily oral TDF/FTC (brand name Truvada). Earlier this year, HPTN 083, a companion trial of CAB-LA among cisgender men and transgender women who have sex with men, reported similar results.

“This is extremely encouraging and exciting news for women around the world,” said Maureen Luba Milambe, AVAC’s African Regional Advocacy Advisor. “We congratulate the trial team and thank especially the more than 3,200 women from Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda and Zimbabwe, whose participation in the study provided this important advance for HIV prevention.”

Data from the trial showed a clear protective benefit from cabotegravir, with an 89% percent risk reduction compared to oral TDF/FTC for PrEP. Overall incidence in the study was 1%, with 1.79% percent in the daily oral PrEP arm and 0.21% in the CAB-LA arm. Of 38 total HIV infections in the study, only four occurred among women who were receiving cabotegravir. Importantly, even though the rate of HIV infection was higher among women taking daily oral PrEP, 1.79% was the lowest incidence among women in a randomized trial of daily oral PrEP to date, underscoring the effectiveness of daily oral PrEP. Over the past 15 years, rates of HIV infection in HIV prevention trials in the region have consistently been closer to 4% when no active drug was provided. HPTN 084 demonstrates that both oral and injectable PrEP are safe and effective options.

As reported today, the HPTN 084 DSMB recommended that the blinded, randomized portion of the study be stopped early and all trial participants be told which active drug (CAB-LA or oral TDF/FTC) they were receiving as part of the study. The study will continue to completion with all participants being offered their preferred product.

“We now know that CAB-LA is highly protective against HIV for both men and women. The urgent work now is for policy makers, funders, program implementers and communities to design and build HIV prevention programs and health systems that can deliver the growing array of biomedical PrEP options, including oral, vaginal ring and injectable, and make them feasible choices for all people at risk of infection,” said Mitchell Warren, AVAC Executive Director. “This is essential work that can and must begin now, while we await further data, regulatory review and potential normative guidelines. Key to those efforts will be ensuring that we don’t repeat the delays that have slowed daily oral PrEP rollout over the past eight years.”

In preparation for the HPTN 084 study results, AVAC, along with a cadre of cisgender women in Africa, Europe and the US, have been working to identify potential issues, opportunities, challenges and concerns about the introduction of a new injectable HIV prevention product. This group will work with other networks of advocates for sexual and reproductive health and rights to continue to articulate an agenda for introduction of CAB-LA in the context of these welcome positive results.

“A new HIV prevention option for women is cause for celebration,” said Chilufya Kasanda Hampongo, a Zambian women’s health advocate with the Treatment Advocacy and Literacy Campaign (TALC). “We know that real choice depends on giving women—and all people—full information about risks and benefits, pros and cons of different methods, and of making sure that those methods are available for people to select from. An injectable will be a great choice for some people; for others, daily oral PrEP or the Dapivirine Vaginal Ring will be the right strategy for reducing HIV risk.”

“We must advance biomedical strategies in the context of comprehensive, community-led programs to deal with violence, stigma and discrimination. COVID-19 has shone a light on the epidemics of sexual and gender-based violence that help drive HIV,” said Yvette Raphael, Executive Director of Advocacy for Prevention of HIV and AIDS (APHA) in South Africa. “To be truly effective, injectable HIV prevention and other biomedical options must also be accompanied by investments in women-led work to break the cycles of violence in our societies.”

Advocates also emphasize the remaining need for significant work to understand how this new product can be effectively delivered in communities and among populations where it is most needed. Understanding user preferences, health system capacity needs, the price of the product and the programs that will deliver it, the potential risk of drug resistance and other issues are all critical parts of the puzzle that must be addressed as quickly as possible.

“In 2018, AVAC and the Clinton Health Access Initiative (CHAI) established the Biomedical Prevention Implementation Collaborative (BioPIC) to work with a wide range of stakeholders to develop an introduction plan for CAB-LA and other next-generation HIV prevention options. Today’s announcement gives new urgency to that work of translating promising research results into public health impact,” said Jessica Rodrigues, AVAC’s Director of Product Introduction and Access. “Operational research to find out how communities and individuals can best be supported to access the drug, and how health systems can be strengthened to deliver it should it be approved for use, is a critical next step and planning must begin now,” said Rodrigues.

Additional HPTN research is ongoing and is needed to understand safety and efficacy of CAB-LA for prevention among adolescent girls and pregnant and breastfeeding women, populations that are often at increased risk for HIV infection. In addition, while oral PrEP, the vaginal ring, and now injectable PrEP expand potential options, continued research is still needed on additional methods to expand options that can meet the needs of all populations.

“People need choices for HIV prevention that will work in their lives,” Luba Milambe added. “As we continue the work to increase access to daily oral PrEP, and plan for regulatory review and introduction of the Dapivirine Vaginal Ring, today’s exciting news on cabotegravir brings us another step closer to ensuring more real choice for effective HIV prevention.”