New HIV drug can only offer hope of ending AIDS if all have access, UNAIDS says
10 July 2024
10 July 202410 July 2024
GENEVA, 10 July 2024— UNAIDS has welcomed the release of Gilead Sciences’ t
GENEVA, 10 July 2024— UNAIDS has welcomed the release of Gilead Sciences’ trial results on the injectable long-acting HIV medicine Lenacapavir for HIV prevention. The result “provides hope of accelerating efforts to end AIDS”, UNAIDS says, “but only if Gilead ensures that all people who need it can have access to this game-changing medicine.”
The recent trial of the medicine among cis-gender women in Uganda and South Africa was so successful that it was halted early. Twice-yearly injections of Lenacapavir showed overwhelming efficacy for preventing HIV infections compared to standard oral preventative HIV medicines, known as pre-exposure prophylaxis (PrEP). Additional trials are ongoing in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States.
UNAIDS has welcomed the “exciting development,” and urged the company to allow generic production of Lenacapavir to all low- and middle-income countries by negotiating voluntary licensing agreements through the Medicines Patent Pool (MPP). The MPP is a UN-backed programme with extensive experience negotiating generics agreements between originators and generic pharmaceutical companies.
Gilead has not yet announced its plans for low and middle-income countries. However, UNAIDS is concerned that Gilead’s latest statement regarding its access strategy for low and middle-income countries mentions only “high incidence countries and resource limited countries” and makes no specific mention of upper-middle-income countries or the Medicines Patent Pool. Upper middle-income countries account for 41% of new HIV infections and 37% of all people living with HIV. These countries are home to millions who cannot afford the prices Gilead charges high-income countries.
“The success of Gilead’s recent Lenacapavir trial is an exciting development. While we still await regulatory approvals, normative guidance and results from the other ongoing trials, this news offers hope that we can enable everyone who would benefit, including especially the most marginalised communities, to have access to the help they need. Enabling equitable global access to new technologies can help get the world on track to end AIDS as a public health threat by 2030,” said Winnie Byanyima, Executive Director of UNAIDS. "However, it is concerning that Gilead’s latest announcement seems to mention neither upper-middle income countries, where people cannot afford anything like Lenacapavir’s current $42,250 price tag, nor a commitment to work with the UN-backed Medicines Patent Pool. Without these safeguards, it cannot be assured that this game-changing medicine will reach all those who need it."
/ENDS
Notes
Data in this press release comes from UNAIDS 2023 Epidemiological estimates (aidsinfo.unaids.org)
The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.
UNAIDS Executive Director, Winnie Byanyima and Brazil’s Minister of Health, Nísia Trindade
Brazil hosts the announcement of the Global Council on Inequality, AIDS and Pandemics
UNAIDS Executive Director Winnie Byanyima and the Director of the University College London Institute for Health Equity, Sir Michael Marmot.
Brazil hosts the announcement of the Global Council on Inequality, AIDS and Pandemics
06 June 2023
06 June 202306 June 2023
UNAIDS launching group to generate evidence on the inequalities driving pandemics and advocat
UNAIDS launching group to generate evidence on the inequalities driving pandemics and advocate for the adoption of multisectoral approaches to strengthen the response to AIDS and other pandemics
BRASILIA/GENEVA, 6 June 2023—Brazil is hosting the announcement of the new Global Council on Inequality, AIDS and Pandemics chaired by The First Lady of Namibia, Monica Geingos, the Director of the University College London Institute for Health Equity, Sir Michael Marmot and the Nobel prize winning economist, Joseph E. Stiglitz. Brazil’s Minister of Health, Nísia Trindade, is a founding member.
“I am delighted to host the announcement of the Global Council on Inequality, AIDS and Pandemics. It is time to convert lessons learned into action by reducing the inequalities driving today’s health crises and strengthening pandemic preparedness for the future,” said Ms Trindade, “Brazil is determined to play its part by making the case for increased collaboration and evidence-based policymaking to build more resilient health systems around the world.”
Social and economic inequalities within countries and between them are exacerbating and prolonging pandemics and amplifying their impact amongst the poorest and the most vulnerable. The same intersecting inequalities that drive HIV, COVID-19, MPox and other diseases are leaving countries and communities at risk of future outbreaks and pandemics. But experience shows that there are actions at the global, regional and national levels that can build pandemic responses that reduce rather than exacerbate inequality.
The work of the Global Council will harness essential evidence for policymakers and elevate political attention to the need for action to end inequalities that fuel AIDS and other pandemics. Crucially, it will encourage and support frontline communities to advocate for the policy shifts necessary to fight current pandemics and better prepare for tomorrow’s outbreaks.
“The AIDS response is one of the best examples of how communities experiencing intersecting inequalities can unite to overcome them and save millions of lives,” said UNAIDS Executive Director, Winnie Byanyima who is a member of the Global Council and is in Brazil for the announcement. “A broad movement of people living with and affected by HIV has brought down the price of medicines and diagnostics, strengthened national health responses, enabled the rise of a strong network of community-led organizations and secured the removal of punitive discriminatory laws in many countries. But evidence-based policies and approaches need to be applied everywhere and for everyone and sadly that’s not the case right now.”
Gender-based inequities endanger the health of women around the world. For example, in countries including Ghana, Côte d’Ivoire, and Liberia HIV prevalence for young women is more than 5 times more than young men of the same age—reflecting, in part, economic and education inequality.
“Gender inequality provides fuel to pandemics like AIDS and COVID-19” said the First Lady of Namibia, Monica Geingos. “It increases the vulnerability of women and girls to deadly viruses by limiting access to knowledge, financial resources, and life-choices and undermines their ability to protect themselves and their families. We have to re-imagine pandemic responses that can reduce inequality rather than exacerbate it.”
“Inequalities in access to health and other essential services are largely the result of deliberate policy choices,” said Joseph Stiglitz. “To fight future pandemics, we must learn the lessons of the HIV response and adopt inequality-busting approaches to make the world a healthier, fairer and safer place for everyone.”
Successes and failures in the HIV response provide valuable lessons on how the world can deal with future pandemics. For example, gay men are more likely to be living with HIV. But laws and policies drive the size of the gap. In Malaysia where gay men are criminalized and arrested gay men are 72 times more likely to be infected than other adults; but in Thailand where same-sex relations are legal and community pandemic response is strong, gay men are only 12 times more likely. Viruses cross population groups. These contribute to why Thailand, with lower inequality, is approaching epidemic control while Malaysia is losing ground in the fight against AIDS.
Meanwhile, the issue of inequality extends beyond HIV to other pandemics. Countries with higher income inequality, for example, have experienced greater COVID-19 mortality. At the height of the COVID-19 pandemic, wealthy countries spent billions of dollars on responses but almost half of developing countries were forced to cut health spending, undermining the capacity to fight global pandemics. Several countries in Africa continue reporting significant numbers of MPox deaths during the pandemic, yet the vaccines being used in high-income countries are not available.
Even within countries that have made good progress against HIV, some communities have struggled to benefit from the staggering pace of medical advances. In Brazil, HIV infections are falling dramatically among the white population as access to treatment is widened and new prevention tools such as PrEP are rolled out but HIV infections among the black population are still on the rise.
“Evidence-based strategies to address the social determinants of health are crucial not only for improved health outcomes for the individual but also for building stronger economies and fairer societies,” said Sir Michael Marmot, from Brasilia. “Health is a good marker of how well a society is doing overall. Health equity tells us about societal inequalities.”
UNAIDS
The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.
Watch: Jovem de Expressao matters to young people in Ceilandia, Brazil
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UNAIDS welcomes the announcement by Medicines Patent Pool (MPP) and ViiV of three licenses signed with generic manufacturers for long-acting PrEP, and urges further urgent action by ViiV
31 March 2023
31 March 202331 March 2023
GENEVA, 31 March 2023 — UNAIDS welcomes the announcement by Medicines Patent Poo
GENEVA, 31 March 2023 — UNAIDS welcomes the announcement by Medicines Patent Pool (MPP) and ViiV of three licenses signed with generic manufacturers Aurobindo, Cipla and Viatris for long-acting Cabotegravir for PrEP (Pre-exposure prophylaxis.) PrEP reduces risk of HIV transmission from sex or injecting drug use. UNAIDS also called for urgent action by ViiV to be taken to reduce the price and increase the production of CAB-LA now.
UNAIDS Deputy Executive Director for Policy, Advocacy and Knowledge, Christine Stegling said:
“UNAIDS applauds this announcement by the Medicines Patent Pool, and congratulates the companies on securing the licensing agreement. The generic production of affordable CAB-LA is essential to preventing millions of new HIV infections. The progress made is a testament to the power of campaigning communities who have mobilised to demand long-acting medicines, and to the determined efforts of access to medicines advocates. UNAIDS thanks ViiV for the commitment to tech sharing made through these agreements, and urges all patent holders of long-acting HIV medicines, including those still in development, to commit to share, and make their technology available, now. UNAIDS welcomes that this is only the first announcement of licensing, not the last, and urges ViiV to expand the geographic coverage of the licensing to all low and middle income countries. Because generic production will take several years to get to medicines being available for use, UNAIDS also urges ViiV to right now provide its own production of CAB-LA to procurers at an affordable price and in volumes that match need. We must all be driven by the fierce urgency of now.”
Progress in the global HIV response is slowing, and too many countries are seeing rising infections. The 2025 targets are in danger, and only bold actions can enable the curve of new infections to be pulled down. The deployment of new technologies such as long-acting CAB-LA at an affordable price is urgent and will help fill critical HIV prevention needs for people facing the highest HIV risks. It is also notably welcome that one of the sub-licenses (Cipla) plans to manufacture in South Africa, in addition to India. This is an important step in support of increased local manufacturing of medicines in Africa.
UNAIDS acknowledges this concrete step towards generic production of needed innovative products but urges that short term solutions be put in place immediately and until generic products are widely available. UNAIDS is notably concerned with the recent announcements that current supplies of CAB-LA are not at all sufficient to meet growing demand, and are much less than procurers have said they could purchase. Transparency in sharing information on volumes and price by ViiV of long-acting CAB-LA is essential to help drive progress in increasing volumes.
It is vital and urgent that long-acting anti-retrovirals for PrEP be made available at an affordable price everywhere they are needed. Middle-income countries are now where the majority of new HIV infections occur and home to many of the key populations most at risk of HIV transmission and who most need access to long-acting ARVs. But many countries are not included in this license despite considerable need for affordable new health technologies.
The issuance of these three licenses should pave the way for sharing technology on other innovations for long-acting HIV prevention and for long-acting treatment. UNAIDS urges that licensing help develop a path for accelerated market entry of generic formulations of long-acting anti-retrovirals not only for prevention, but also for treatment, when normative guidance is established, and regulatory approvals are in place at country level.
UNAIDS calls on the private sector, governments and funders to ensure that everyone who needs long-acting antiretrovirals can access them. UNAIDS will continue working with the Coalition to Accelerate Access to Long-Acting PrEP that is jointly convened by the Global Fund on AIDS, TB and Malaria, PEPFAR, Unitaid and the World Health Organization (WHO) with AVAC as its Secretariat to find solutions and ensure equitable global access to pandemic-fighting technologies for all.
UNAIDS
The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.
“ViiV Healthcare needs to publicly announce an interim pricing strategy, which prioritises affordability so countries and procurement bodies can plan and purchase at scale,” said Dr Yogan Pillay, South Africa country director at The Clinton Health Access Initiative. “Governments and other procurers will only purchase long-acting injectable HIV medicines at scale if the drugs are affordable and if there’s a clear timeline as to when the drugs will be available.”
“ViiV Healthcare should allow generic production and supply in all low- and middle-income countries,” said Lilian Mworeko, Executive Director, International Community of Women Living with HIV East Africa. “Anything short of this would mean that millions of people who need these products would not be able to access them for years to come. Every day of delay would represent failure to prevent the spread of HIV and takes us further away from ending AIDS by 2030.”
Illustration in WHO's Guidelines on long-acting injectable cabotegravir for HIV prevention.
Delays in global, affordable access to long-acting, injectable HIV medicines would cost lives, say AIDS campaigners
16 November 2022
16 November 202216 November 2022
GENEVA – Reflecting on 100 days since the 24th International AIDS Confer
GENEVA – Reflecting on 100 days since the 24th International AIDS Conference in Montreal, at which the World Health Organisation issued landmark guidance on how long-acting injectable anti-retroviral medicines can help prevent new HIV infections, and ViiV Healthcare committed to enabling access, AIDS campaigners are urging ViiV Healthcare to take vital next steps to enable timely rollout of game-changing, life-saving, long-acting injectable HIV medicine to millions of people.
At AIDS2022, the International AIDS Conference in Montreal, 29th July - 2nd August, ViiV Healthcare the manufacturer of cabotegravir (CAB-LA) committed to share technology, and ensure an affordable price, for the long-acting, injectable HIV medicine. The announcement generated international excitement as CAB-LA has been shown to be a safe and effective prevention tool. Reflecting on 100 days since then, global health leaders say there is an urgent need to for ViiV to take crucial next steps.
ViiV committed at the Conference in Montreal to lower the price for CAB-LA in a subset of low- and middle-income countries. But ViiV has not yet published this price. Advocates say the annual per person price needs to be equivalent to the price of oral PrEP, tens of dollars not hundreds of dollars. Multiple governments and financing agencies have indicated their interest in purchasing CAB-LA for PrEP if the medicine is offered at an affordable price point. Advocates are calling on ViiV to transparently and rapidly share details of their planned pricing strategy.
“ViiV Healthcare needs to publicly announce an interim pricing strategy, which prioritises affordability so countries and procurement bodies can plan and purchase at scale,” said Dr Yogan Pillay, South Africa country director at The Clinton Health Access Initiative. “Governments and other procurers will only purchase long-acting injectable HIV medicines at scale if the drugs are affordable and if there’s a clear timeline as to when the drugs will be available.”
While ViiV’s commitment to facilitate the generic production of CAB-LA via an agreement with the Medicines Patent Pool for use in 90 countries is helpful, HIV experts are calling on ViiV to allow an expansion of the number of countries eligible in order to accelerate progress in supplying the product to those in need. Although the current set of 90 countries includes both low- and middle-income countries, it excludes dozens of other middle-income countries, amongst which are countries with high rates of HIV infection. Expanding the list of countries would help incentivise generic production by expanding the potential market size.
“ViiV Healthcare should allow generic production and supply in all low- and middle-income countries,” said Lilian Mworeko, Executive Director, International Community of Women Living with HIV East Africa. “Anything short of this would mean that millions of people who need these products would not be able to access them for years to come. Every day of delay would represent failure to prevent the spread of HIV and takes us further away from ending AIDS by 2030.”
“At the AIDS Conference in Montreal, ViiV took important first steps to enable this powerful new prevention tool to reach many in need. It is now time for ViiV to take additional courageous steps. These include ensuring registration with medicines agencies in all the countries with the highest rates of HIV, announcing the low price and expanding the set of countries allowed in the generic market. Bold actions by ViiV in this moment could help save millions of lives,” said Matthew Kavanagh, Deputy Executive Director, a.i. at UNAIDS.
Guidelines on long-acting injectable cabotegravir for HIV prevention
unaids.orgUNAIDS
UNAIDS responds to EU approval of a long acting HIV treatment option: “To end AIDS, share technology.”
23 August 2022
23 August 202223 August 2022
Responding to the news that the European Commission has approved an HIV treatment option designed
Responding to the news that the European Commission has approved an HIV treatment option designed for twice-yearly dosing, UNAIDS Executive Director Winnie Byanyima said:
‘It is great news that a range of long-acting HIV treatment options are set to come on stream. A range of options for long-acting treatments, received every few months, could enable more people to get on treatment or offer better clinical options for patients showing resistance to current regimens, therefore staying longer on treatment, and prevent many AIDS-related deaths – if they become available for all who need them. The evidence is clear: monopoly production cannot ensure global availability and affordability. Worldwide availability of affordable long-acting treatments will require the transfer of technology to enable generic production.’
Progress in long-acting treatments follows progress in long acting prevention. The recent decision by ViiV to share its long-acting HIV prevention technology to enable generic production has demonstrated that sharing is possible for companies to do. UNAIDS welcomed that decision and is urging an expansion of the number of countries included. Currently, many upper middle-income countries do not have access to these technologies. Achieving global targets to end AIDS would require countries around the world have access to newer technologies. As a range of companies advance their development of long-acting HIV treatments, they should build on ViiV’s precedent, expanding the number of countries, and learn from it by not waiting until after launch to transfer the technology.
Ms Byanyima said:
‘Delays in the transfer of technology of innovative health products cost lives. The process of sharing of long-acting treatment technology, of the intellectual property rights and “recipes”, should not wait for after long-acting HIV treatment medicines are made available to people in rich countries. That process should begin at the early stages of the Research and Development (R&D) cycle. Sharing technology now, to help producers prepare, will save lives and help end the AIDS pandemic. The transfer of pandemic-ending technologies to low- and middle- income countries is not only the right thing to do, it is in the self-interest of rich countries too. We can only end AIDS by ending AIDS everywhere. To end AIDS, share technology. Now.’
The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.
Related: UNAIDS welcomes ViiV’s agreement to enable generic production of long acting PrEP to 90 countries
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UNAIDS welcomes ViiV’s agreement to enable generic production of long acting PrEP to 90 countries
28 July 2022
28 July 202228 July 2022
MONTREAL/GENEVA, 28 July 2022—UNAIDS welcomes the agreement between ViiV an
MONTREAL/GENEVA, 28 July 2022—UNAIDS welcomes the agreement between ViiV and the Medicines Patent Pool to enable access to generic formulation of long acting Cabotegravir for PrEP to 90 low- and lower-middle income countries.
UNAIDS Deputy Executive a.i. Dr Matthew Kavanagh said:
“UNAIDS applauds this decision by ViiV, and congratulates the Medicines Patent Pool for securing this agreement. Supporting the production of affordable generic CAB-LA could keep millions of people safe from HIV.
Some pharmaceutical companies have claimed that technology sharing undermines the development of technology—but this licensing deal proves that companies can share and prosper.
Progress in the global HIV response is slowing, and in too many countries we are even seeing rising infections. The 2025 targets are in danger, and only bold actions can enable the curve of new infections to be pulled down. We cannot afford to wait for new technologies to be deployed. Further action is essential to ensure that the potential that this announcement brings is fully realised.
First, it is vital that the license be extended to more than the 90 countries named. Middle-income countries are now where the majority of new HIV infections occur and home to many of the key populations most at risk of HIV and who most need access to long-acting ARVs. But many are not included in this license despite considerable need for affordable new health technologies.
Second, as generic production will take several years to come online, it is crucial that ViiV commit to sell CAB-LA in low- and middle- income countries at a price as close as possible to the current cost of Oral PrEP—currently approximately $60. This would enable ViiV to prevent millions of new HIV infections.”
UNAIDS commends the non-exclusivity clauses of the agreement, which allows qualified generic producers all over the world to express the interest in producing it. UNAIDS encourages ViiV and MPP to support generic producers in developing this new technology through a consistent transfer of technology package that goes beyond the licensing aspects.
This agreement could pave the way for sharing of technology on long acting treatment, too. UNAIDS urges that licensing help develop a path for accelerated market entry of generic formulations of long-acting ARVs not only for prevention, but also for treatment, when normative guidance is established.
UNAIDS calls on businesses, governments and funders ensure that everyone who needs long acting antiretrovirals can access them.
“We urge all companies developing long-acting HIV medicines to commit to sharing technology through the Medicines Patent Pool, and all governments to act rapidly to secure affordable access to the newest technologies for all who would benefit from them,” said Dr Kavanagh. “There must be no repeat by any company of the deadly delays in rolling out HIV products that we saw early on in the AIDS epidemic and that has recently been repeated with COVID-19 vaccines and therapeutics. Sharing technology is essential for stopping pandemics.”
UNAIDS
The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.
UNAIDS responds to Viiv’s announcement on the licensing of long-acting Cabotegravir
27 May 2022
27 May 202227 May 2022
HIV medicine manufacturer Viiv has announced that it is “actively negotiating” a voluntary licens
HIV medicine manufacturer Viiv has announced that it is “actively negotiating” a voluntary license with the Medicines Patent Pool on long-acting Cabotegravir.
The World Health Organization will soon issue updated global guidelines on the appropriate application of new long-acting HIV medicines.
Responding to the announcement made by Viiv, UNAIDS Deputy Executive Director a.i. Matt Kavanagh said:
“Last year there were 1.5 million new HIV infections, which shows the urgency of global access to new tools to overcome this pandemic. A successful global HIV response depends on the sharing of technologies. We are encouraged by ViiV’s announcement of negotiations with the Medicines Patent Pool, which has followed engagement by UN partners, financing agencies, civil society, and others. The announcement is an important sign of progress toward affordable global access to this technology for the HIV response; it now needs to be followed by rapid action, in order to translate promises into medicines.
To have transformative impact as a tool for HIV prevention on the scale needed, it is vital that a license for this long-acting antiretroviral come quickly, with open non-exclusive terms for use and production across the world’s low- and middle-income countries. The licensing agreement should also be accompanied by an effective transfer of a technology package, to facilitate quality-assured manufacturers around the world to produce the medicines as soon as possible. There is an urgent need for large-scale production to get underway in Africa, Asia, Latin America and beyond, as soon as possible, to minimize the further wait for affordable products where they are most needed.
Because generic manufacturing will take time to get running, even once a license is agreed, it is also key that ViiV name an interim price that is affordable for low- and middle-income countries.
Those who need new HIV prevention tools most are too often those who get access last — but this need not happen.
We can, as promised, end AIDS as a public health crisis by 2030 – if leaders act boldly to address the inequalities which have driven it. Hoarding life-saving science hurts everyone; it perpetuates pandemics. Sharing life-saving science benefits everyone."
UNAIDS
The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.
UNAIDS welcomes the approval of long-acting injectable cabotegravir as a pre-exposure prophylaxis for HIV prevention
22 December 2021
22 December 202122 December 2021
The United States Food and Drug Administration announced its first approval of a long-acting HIV
The United States Food and Drug Administration announced its first approval of a long-acting HIV prevention medication earlier this week. The long-acting injectable cabotegravir (CAB - LA) is approved as a pre-exposure prophylaxis (PrEP) for adults and adolescents who are at risk of acquiring HIV sexually in the United States of America.
This is the first time an injectable antiretroviral drug becomes available as a pre-exposure prophylaxis for prevention of HIV. The long-acting formula is a step forward and a valuable addition to the HIV prevention toolbox and will make acceptance and adherence easy.
A long-acting PrEP product such as CAB-LA, taken initially as two injections one month apart and then after every two months afterward, could offer a better choice for adults and adolescents at substantial HIV risk who either do not want to take or struggle with taking a daily tablet. Companies holding new technologies should share their knowledge and recipes with generic producers to ensure availability and affordability in low and middle-income countries.
UNAIDS is calling for this new drug to quickly be made available and affordable to people who need it most not just in the United States of America but everywhere in the world. The mistakes of three decades ago when lifesaving drugs were only available to those who could afford it must not be repeated. Market strategies such as generic competition and public health-oriented management of intellectual property rights, either through voluntary agreements or the use of TRIPS flexibilities must be used to make this new drug widely available.
To make this drug available equitably across the world, a series of actions are essential. Firstly, the drug has to be approved by regional and national regulatory authorities in a speedy manner. It is encouraging to see that the developer of CAB-LA, has already submitted to the South African Health Products Regulatory Authority (SAHPRA) for approval and an outcome is expected in early 2022. However access must go much further. Secondly the selling price must come down through a combination of measures such as licencing and involvement of generic producers. Thirdly, national HIV prevention programmes must prepare roll out plans and prepare their health systems and communitiues to deploy this new HIV prevention option as soon as they are available.
Current pre-exposure prohylaxis--Tenofovir plus Emtricitabine—tablets have to be taken daily as oral PrEP. They are highly effective in preventing HIV acquisition among persons at substantial risk when taken as prescribed. However many find it challenging to take a daily tablet. Another option—dapiviringe vaginal ring—is becoming available as additional prevention option for women at substantial risk of HIV infection.
The CAB-LA option could be a game-changer for the HIV response, making PrEP simpler or less burdensome for all genders. This may also circumvent the stigma associated with daily oral therapy and improve correct dosing and adherence which is critical for PrEP effectiveness.
This week’s United States Food and Drug Administration approval follows results from two trials. The first trial, HPTN 083, was conducted in 4 566 gay men and men who have sex with men and transgender women at research centers in Argentina, Brazil, Peru, the United States, South Africa, Thailand, and Vietnam. CAB – LA reduced the risk of sexually acquired HIV by 66% compared to daily oral. In the second trial HPTN 084, among 3,223 at-risk women aged 18-45 across 20 trial sites in seven countries in Sub Saharan Africa (Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda, and Zimbabwe), CAB – LA reduced the risk of acquiring HIV by 89% compared to daily oral PrEP.
UNAIDS
The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.