Latest news with #PrEP
Indian Express
28 minutes ago
- Health
- Indian Express
As US FDA approves HIV prevention drug Lenacapavir, expert says ‘India needs to take lead for its equitable, timely distribution
The United States Food and Drug Administration (FDA) on Wednesday approved Lenacapavir (LEN), the most promising HIV prevention medicine to be made so far, and according to Dr I S Gilada, president emeritus, AIDS Society of India, the real breakthrough would be when LEN becomes accessible, affordable and available to everyone in India and across the world. Lenacapavir is an antiretroviral medicine that is used for HIV prevention as a pre-exposure prophylaxis or PrEP. PrEP is a medication that can reduce the risk of HIV infection for individuals who are HIV-negative but are at risk of contracting the virus. The results of two key studies have shown that it helps prevent 99.9 per cent of all HIV transmission. 'LEN is an injectable PrEP that is to be taken twice yearly,' said Dr Glory Alexander, president of AIDS Society of India (ASI) and founder director of ASHA Foundation, Bengaluru. PrEP was first approved by the US FDA in 2012, but the Indian government's National AIDS Control Organisation is yet to roll it out. 'If we invest in HIV prevention, we not only protect people's health but also save expenses in providing lifelong HIV care, including lifelong antiretroviral therapy (ART). HIV prevention must remain at the centre-stage of our national AIDS response,' said Dr Gilada. 'Indian regulators should work with Indian generic manufacturing companies to ensure that 'made in India' generic LEN versions when available, are first rolled out in India,' Dr Gilada told The Indian Express. 'The scientific breakthrough translates into public health impact in terms of stopping the spread of HIV infection. The major impediment is the cost: LEN as PrEP to be sold as Yeztugo by Gilead is priced at US$ 28,218 per person per year. However, Gilead's wisdom by giving voluntary licenses to four Indian generic companies, gives hope that the medicine may cost less than US$ 100 – that is 0.3 per cent of the innovator's cost,' Dr Gilada explained. 'India needs to lead from the front for LEN's equitable and timely distribution at the required scale to prevent HIV transmission and help end AIDS,' said Dr Gilada, adding that only India can deliver LEN to all those in need worldwide, in terms of quality, quantity and speed. Though India meets 92 per cent of the global requirement for ART and the global community (WHO, UNAIDS, Global Fund, World Bank, etc) widely uses Indian generic pharma for their strategies like Treatment as Prevention (TasP), Test and Treat, Post-exposure Prophylaxis (PEP), PreP, etc, it is unfortunate that they are shy to acknowledge this, he said. Gilead had faced a lot of backlash from health advocates and communities last year over the astronomical pricing for LEN, pegged at over US$ 40,000 per person per year, which has now been slashed by 30 per cent. Earlier, Gilead's Hepatitis C treatment, which cost $84,000 in the US for a three-month course, was made available in India for less than $300. So the firm knew what was to be done this time, and granted voluntary licensing to six generic manufacturers, including four Indian: Dr Reddy's Laboratories, Emcure, Hetero Healthcare, and Viatris. 'All international antiretroviral therapy and prevention guidelines are conceptualised and implemented on the strength of India. Only India can meet the global demand for LEN at such low cost, just as it did for ART, at 0.3 per cent of the innovator's cost,' Dr Gilada said. Anuradha Mascarenhas is a journalist with The Indian Express and is based in Pune. A senior editor, Anuradha writes on health, research developments in the field of science and environment and takes keen interest in covering women's issues. With a career spanning over 25 years, Anuradha has also led teams and often coordinated the edition. ... Read More
Indian Express
7 hours ago
- Health
- Indian Express
US FDA approves HIV prevention drug: Why is this a breakthrough?
A twice-yearly injectable drug for the prevention of HIV infection has been approved by the United States' Food and Drug Administration. With better compliance expected — instead of daily pills on a shot every two months that people have to take at the moment — it is one of the most anticipated developments in the field of HIV prevention. The Lenacapavir injection — sold as Yeztugo by pharmaceutical giant Gilead — was approved based on the results of two Phase 3 trials that showed 99.9% of individuals remained HIV negative with the two shots taken annually. 'FDA approval … paves the way for WHO prequalification, which can accelerate national regulatory approvals … and procurement by donor agencies like the Global Fund… Lenacapavir's discreet, long-acting formulation may help overcome key barriers such as daily pill burden, frequent clinic visits and stigma associated with HIV prevention,' the World Health Organization (WHO) said. Lenacapavir is an anti-retroviral medication that can be used to treat as well as prevent HIV. As Sunlenca, it is used in combination with other antiretroviral drugs for the treatment of people who have been on pills for a very long time and are resistant to multiple drugs. As Yestugo, it is a pre-exposure prophylaxis (PrEP) to prevent the infection. The drug works by binding with the HIV capsid — a protein shell that protects the virus' genetic material. It then disrupts crucial steps needed for the virus to replicate and infect new cells. PrEP or pre-exposure prophylaxis is a drug or injectable meant to prevent HIV infection in people at a higher risk of contracting the disease. These medicines can reduce the risk of acquiring HIV infection through sexual activity by 99% and through injection drug use by 74%. At present, there are several types of PrEP available — pills such as Truvada or Descovy, Dapivirine vaginal ring and the injectable Cabotegravir that has to be taken every two months. It is important to be tested for HIV before taking PrEP. While these medicines are also used in the treatment of HIV, they are prescribed in combination with other antiretrovirals. Given alone to a patient with HIV, they might develop resistance to the drugs. PrEP is usually recommended for people living with an HIV positive partner, those who frequently change partners, those who have sex with people with unknown HIV status, those who work in the sex industry, and those who use injectable drugs. Medicines for post exposure prophylaxis are also available to be used as an emergency measure in cases such as inadvertent exposure in a hospital setting, after condom failure, or during sexual assault. While generic versions of the PrEP pills are approved in India — Cabotegravir injection is also available through a sub-licensing contract — they are not widely used. This is mainly owing to the cost of the medicines and the fact that they are not yet part of the country's national programme, which already provides life-long treatment to all who have been diagnosed with HIV. The new injectable will cost USD 28,218 annually, remaining out of reach for many. Even in the US, usage remains low. Only 36% of the 1.2 million people who would have benefited from the medicine were prescribed it. Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government's management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Dutt also takes a keen interest in the country's space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University's Dart Centre. Dutt has a Bachelor's Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times. When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More
Reuters
10 hours ago
- Health
- Reuters
Insight: Trump aid cuts deal a blow to HIV prevention in Africa
June 20 (Reuters) - Emmanuel Cherem, a 25-year-old gay man in Nigeria, tested positive for HIV two months after U.S. President Donald Trump's administration cut access for at-risk groups like gay men and injecting drug users to medication that prevents infection. Cherem admits he should have been more careful about practicing safe sex but had become accustomed to using the U.S.-supplied pharmaceutical. The drug - known as Pre-Exposure Prophylaxis, or PrEP - is typically taken daily as a tablet and can reduce the risk of contracting HIV through sex by 99%. "I blame myself... Taking care of myself is my first duty as a person," Cherem said at his gym in Awka, the capital of Nigeria's southeastern state of Anambra. "I equally blame the Trump administration because, you know, these things were available, and then, without prior notice, these things were cut off." Trump ordered a 90-day pause on foreign aid after taking office in January and halted grants by the U.S. Agency for International Development (USAID). The agency was responsible for implementing the bulk of the assistance under the President's Emergency Plan for AIDS Relief (PEPFAR), the world's leading HIV/AIDS initiative. Sub-Saharan Africa remains the epicenter of the AIDS pandemic. Trump's cuts have restricted the availability of drugs that millions of Africans have taken to prevent infection - particularly vulnerable communities such as gay men and sex workers - as aid groups and public health systems in Africa strove to roll back the disease. The number of initiations, or people who have taken at least one dose of the drug, rose in Africa from fewer than 700 in 2016 to more than 6 million by late 2024, according to PrEPWatch, opens new tab, a global tracker. More than 90% of new initiations last year were financed by PEPFAR, using cheap generic versions of the drug. Sub-Saharan Africa had 390,000 AIDS-related deaths in 2023, or 62% of the global total, according to UNAIDS, the United Nations AIDS agency. However, progress has been made: that death toll was down by 56% from 2010, according to the World Health Organization. Now, some of those who've lost access to the preventative medication because of U.S. cutbacks are already testing positive, according to 10 patients, health officials and activists. Restrictions on PrEP have coincided with dwindling supplies of more widely used HIV prevention tools like condoms and lubricants "because of the US funding cuts", according to a UNAIDS fact sheet, opens new tab from May. The combination is creating what nine activists and three medical experts described as a major threat to prevention across the continent. "I just see this as incredibly short-sighted because we were on a winning path," said Linda-Gail Bekker, an HIV expert at the University of Cape Town. She said that many African governments did not have the resources to spend on PrEP drugs on top of treatment for HIV infections, risking a worsening of the pandemic. "It's as predictable as if you take your eye off a smouldering bushfire and the wind is blowing: a bushfire will come back." Trump has said that the United States pays disproportionately for foreign aid and he wants other countries to shoulder more of the burden, as he seeks to reduce U.S. government spending across the board. The U.S. disbursed $65 billion in foreign assistance last year, nearly half of it via USAID, according to government data, opens new tab. "It's a question of who has primary responsibility for the health needs of citizens of other countries, and it's their own governments," said Max Primorac, a former senior USAID official who is now senior research fellow at The Heritage Foundation's Margaret Thatcher Center for Freedom. "We all know, and this is a bipartisan issue, that aid dependency doesn't help these people - that the best solution is for these countries to be able to take over the responsibility of these programs." UNAIDS says the permanent discontinuation of PEPFAR-supported prevention and treatment programs could lead to an additional 2,300 new HIV cases globally per day. There were 3,500 new cases per day in 2023. Reuters spoke to 23 health workers, PrEP users and activists, nearly all of whom said that the increase in HIV infections since the funding cuts was impossible to quantify because many organisations working with vulnerable populations have been defunded. A State Department waiver issued on February 1 allowed some PEPFAR activities to restart, but only covered HIV prevention for mother-to-child transmission. That means PEPFAR-financed PrEP is no longer available for gay and bisexual men, sex workers and injecting drug users who are especially exposed to the virus. Many African governments had specifically targeted these groups in their PrEP programs. A spokesperson for the State Department, which oversees USAID and the PEPFAR program, told Reuters it "continues to support lifesaving HIV testing, care and treatment, and prevention of mother to child transmission services approved by the Secretary of State." "All other PEPFAR-funded services are being reviewed for assessment of programmatic efficiencies and consistency with United States foreign policy," the spokesperson said. The spokesperson did not directly respond to a question about why the waiver had excluded vulnerable groups from PrEP distribution. In East and Southern Africa, the sub-region that accounts for more than half of all people living with HIV, the U.S. had been funding nearly 45% of HIV prevention programming, UNAIDS said in March, opens new tab. Some countries like Malawi, Zimbabwe and Mozambique were almost entirely dependent on PEPFAR for their HIV prevention programs, the agency said. In some wealthier nations, like South Africa and Kenya, PEPFAR represented less than 25% of spending on HIV prevention. Russell Vought, the director of the U.S. Office of Management and Budget, told a Congressional committee on June 4 that, due to high U.S. debt levels, Africa needed to shoulder more of the burden in fighting AIDS. Asked specifically about restrictions on HIV prevention programs, Vought said: "We believe that many of these nonprofits are not geared toward the viewpoints of the administration." His office did not respond to a request for further details. Reuters spoke to four PrEP users in Nigeria, all gay or bisexual men, who have tested positive for HIV since January when they stopped being able to obtain more pills, after practicing unsafe sex. Hearty Empowerment and Rights (HER) Initiative, a community-based organisation in southeastern Nigeria, worked with other groups that provide HIV/AIDS services to confirm the men's diagnosis and help secure treatment for them, said executive director Festus Alex Chinaza. In Asaba, the capital of Nigeria's Delta state, Echezona, a 30-year-old gay man who took PrEP pills daily for more than three years, is struggling to come to terms with his HIV-positive test result, which he received in early May. He regrets that he had unprotected sex. "I just pray and wish that Trump actually changes his policy and everything comes back to normal so that the spread and transmission of the virus would be reduced," said Echezona, who asked to be identified only by his first name for fear of stigma. Like the other three men, he described being told by staff at community-based clinics that PrEP was only available to pregnant and lactating women, in line with the Trump administration guidelines. Nigeria has an adult HIV prevalence rate of 1.3% and an estimated 2 million people living with HIV, the fourth-highest total globally, according to UNAIDS. But for so-called key populations, the rates are much higher: 25% for men who have sex with men, according to a survey completed in 2021. The Nigerian health ministry did not respond to a request for comment on the effects of the Trump administration's cuts to HIV prevention services. South Africa – which has an estimated 7.7 million people living with HIV, according to UNAIDS, the highest number in the world - pays for its own PrEP pills. But some clinics where so-called key populations obtained them relied on PEPFAR grants and have been forced to close in recent months. PrEP is also available for free at public health centers, but gay men and sex workers often avoid such facilities, fearing discrimination and harassment, nine activists said. Francois Venter, executive director of the Ezintsha medical research center at the University of the Witwatersrand in Johannesburg, said PrEP distribution from public sector clinics in the city had shown almost no increase since the Trump cuts. Foster Mohale, spokesperson for South Africa's health ministry, said the ministry was "not aware" of reports that key populations were avoiding health facilities due to stigma. "We have sensitized health officials across the country to create (a) conducive environment for all healthcare seekers/clients to access the service without feeling judged or discriminated against," he said.
Economic Times
10 hours ago
- Health
- Economic Times
US approves Gilead's twice-yearly injection to prevent HIV
AP This photo provided by Gilead Sciences shows packaging for the company's HIV prevention medication, Yeztugo, (lenacapvir) at a manufacturing facility in La Verne, Calif., in June 2025. The US Food and Drug Administration on Wednesday approved Gilead Sciences' twice-yearly injection to prevent HIV -- a move the company hailed as a major breakthrough in the fight against the sexually transmitted virus. Drugs to prevent HIV transmission, known as pre-exposure prophylaxis or PrEP, have existed for more than a decade. But because they typically require taking a daily pill, they have yet to make a significant dent in global infections. "This is a historic day in the decades-long fight against HIV," Gilead chairman and chief executive Daniel O'Day said in a statement. Lenacapavir, marketed under the brand name Yeztugo, has been shown to reduce the risk of HIV transmission by more than 99.9 percent in adults and adolescents -- making it functionally akin to a powerful vaccine. The company conducted two large clinical trials. The first, involving more than 2,000 women in sub-Saharan Africa, resulted in a 100 percent reduction in infections and demonstrated superiority over the daily oral pill Truvada. In the second trial, involving over 2,000 men and gender-diverse individuals, only two infections were recorded - a 99.9 percent prevention rate, again surpassing side effects included injection site reactions, headache, and from both trials were published in The New England Journal of Medicine, and the journal Science named lenacapavir its 2024 "Breakthrough of the Year."- Price concerns dampen hope -Despite the impressive results, optimism may be tempered by the drug's cost -- a list price of $28,218 per year in the United States, Gilead spokeswoman Blair Baumwell told AFP in an email Wednesday. An earlier long-acting HIV prevention shot -- cabotegravir, which is injected every two months and was approved by the FDA in 2021 -- costs tens of thousands of dollars per year and has yet to make a major global impact. Lenacapavir's current list price for its previously approved use as a treatment for HIV is $39,000 said the $28,000-plus per year cost for Lenacapavir as a preventive drug is "in line with" those of existing PrEP products and that the company inspects insurers to cover it."We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage," she said in the are urging Gilead to drastically cut the price to help end the HIV pandemic."Even high-income countries will not be able to afford widescale use of lenacapavir at prices above US $20,000 per year," said Andrew Hill of Liverpool University, who led a team of chemists and scientists that found it could be mass-produced and sold for as little as $25 per person per year."I congratulate Gilead and US partners for advancing this important innovation," added Winnie Byanyima, under-secretary-general of the United Nations. "Lenacapavir could be the tool we need to bring new infections under control -- but only if it is priced affordably and made available to everyone who could benefit."In October, Gilead signed agreements with six pharmaceutical companies to produce and distribute generic versions of the drug, pending regulatory approval, in 120 low- and middle-income it will take time for those countries to begin production, the company also announced a separate deal in December with the Global Fund -- an international partnership established by the United Nations, alongside the US President's Emergency Plan for AIDS Relief (PEPFAR) and others -- to purchase doses for two million cuts to the PEPFAR program under President Donald Trump's administration have cast uncertainty over the future of that agreement.
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Business Standard
10 hours ago
- Health
- Business Standard
USFDA approves first HIV prevention shot needing only two doses a year
Even after decades of medical progress, HIV continues to infect thousands globally each day, according to estimates by the World Health Organization. In a major breakthrough, the US Food and Drug Administration (FDA) on Thursday approved lenacapavir, a long-acting injectable drug that offers near-complete protection against HIV with just two doses a year. Lenacapavir, developed by Gilead Sciences and marketed under the brand name Yeztugo, is the world's first twice-yearly HIV prevention shot. It could transform pre-exposure prophylaxis (PrEP) options, particularly for those who struggle with daily medication adherence due to stigma, access issues, or lifestyle factors. How does lenacapavir work? Lenacapavir is a capsid inhibitor, a class of drugs that blocks the protein shell (capsid) the HIV virus needs to replicate. Unlike oral PrEP pills that must be taken daily, lenacapavir is administered as an injection once every six months, providing a discreet and highly effective method of prevention. How effective is lenacapavir against HIV? In two large-scale clinical trials conducted by Gilead: The first trial involved over 2,000 women in sub-Saharan Africa and showed a 100 per cent reduction in HIV infections, outperforming the daily oral PrEP pill Truvada. The second trial, involving over 2,000 men and gender-diverse individuals, reported only two infections, yielding a 99.9 per cent prevention rate. 'This medicine only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention,' said Daniel O'Day, Chairman and CEO of Gilead Sciences. 'With the FDA approval of Yeztugo, we are one step closer to ending HIV.' Is lenacapavir safe? Clinical trials report that lenacapavir is well tolerated, with mild injection site reactions being the most common side effect. No serious safety concerns have emerged, making it a viable long-term option for prevention. Who stands to benefit the most? The twice-yearly dosing offers particular promise for: Young women LGBTQ+ individuals People in remote or underserved regions Public health experts say it will improve adherence and reduce infection rates in communities often left behind by daily-pill-based prevention strategies. When will lenacapavir be available outside the US? While the FDA has cleared the drug, approvals in other countries are still pending. Applications are under review in Europe, Australia, Canada, South Africa, Brazil, and Latin America. The World Health Organization is expected to release global guidance on July 14 during the International AIDS Conference in Kigali. How much will Yeztugo cost? Gilead has yet to announce the price of Yeztugo. However, analysts estimate that the US launch could cost up to $25,000 per year. Currently, lenacapavir is priced at $39,000 annually for HIV treatment use, though prices are expected to fall for prevention. Advocacy groups such as UNAIDS and Unitaid are calling for significant price reductions in low- and middle-income countries. Generic manufacturing is being explored, with estimates suggesting a potential price of $25–$46 per year if Gilead grants licences. What's the HIV situation in India? According to the National AIDS Control Organisation (NACO), an estimated 2.4 million people were living with HIV in India in 2021. That year, 41,970 AIDS-related deaths were recorded, underscoring the ongoing public health challenge.
