US FDA approves Gilead's twice-yearly injection to prevent HIV
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 struggled to make a significant dent in global infections.
"This is a historic day in the decades-long fight against HIV," said Daniel O'Day, Gilead's chairman and chief executive officer, in a statement.
Lenacapavir, marketed under the brand name Yeztugo, has been shown in clinical trials 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.
But optimism may be tempered by the drug's expected eye-watering price tag.
While the company has not disclosed specifics, analysts estimate the US launch price could be as high as $25,000 per year.
Activists are calling for the price to be slashed to $25 per person annually to help end the HIV pandemic.
The approval also comes as President Donald Trump's administration has slashed funding for HIV treatment and prevention programs both overseas and within the United States. — Agence France-Presse
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
GMA Network
2 days ago
- GMA Network
FDA: Dengue, ASF vaccines still pending approval
The Food and Drug Administration (FDA) said Tuesday they are still processing the approval of vaccines intended to counter Dengue and African Swine Fever. During an ambush interview on Tuesday, FDA Director General Paolo Teston said they are still waiting for several required documents for post-approval from the applicants of the ASF vaccine. 'Nag-uundergo po siya ng post-approval commitment compliance po ng naaprubahan po na una ng FDA. Marami pa pong submission requirements po… Ang FDA naman po ay patuloy na naghihintay sa submissions, sa pagsusumite ng nabigyan po ng monitored release ng certificate of product registration (CPR),' he shared. (It is undergoing post-approval commitment compliance when it was initially approved by the FDA. There are still a lot of submission requirements… The FDA continues to wait for submissions for those granted with monitored release of the CPR.) Teston said that compliance with the needed submissions may be enough for a CPR, but that applicants would still need to comply with post-approval commitments. He added the ASF vaccine is undergoing scrutiny from the FDA's fact-finding committee. 'Sana po pwede ko sabihin na yesterday yung timeline namin [ng approval], pero ang FDA po talaga ang concern niya is health and safety ng mga produkto. We cannot compromise po yung safety ng produkto na gagamitin sa ating livestock, particularly sa mga baboy po, para lang po mapabilis yung proseso,' he said. (I hope I could say that our timeline [of approval] was yesterday, but the FDA's concern is the health and safety of these products. We cannot compromise the safety of the product that will be used on our livestock, particularly on pigs, just to speed up the process.) Teston said should applicants be able to properly submit all necessary documents, the vaccine should be approved within the year. 'Kailangan lang din po namin sagutin yung ibang issue kasama yung pre-approval na natanong po nung nagkaroon po ng inquiry sa Congress about dito sa ASF vaccine,' he said. (We just have to address the other issues, including the pre-approval that had been raised during a Congress inquiry about the ASF vaccine.) Meanwhile, Teston shared that TAC-003 or QDenga vaccine against dengue is now being assessed by an FDA expert panel. The QDenga vaccine is an live-attenuated vaccine with an 80% first year post-vaccination efficacy against Virologically Confirmed Dengue (VCD) fever, recommended for prevention of the disease in people who had never been infected and had already been approved in more than 40 countries with over 10 million doses distributed nationwide. 'Ito ay sumasailalim sa pagsusuri ng expert panel both po ng FDA at pati expert panel ng external ng FDA,' he said. (This is undergoing an investigation from the FDA's expert and external expert panels.) 'Independent po kasi yung expert panel ng FDA dahil sila po yung nakakaalam, sila po yung nag-aassure ng quality and safety and efficacy ng produkto, lalo na pag bago yung produkto,' Teston added. (The FDA expert panel is independent because they are the ones whom understand, and they are the ones that assure the quality and safety and efficacy of the product, especially if the product is new.) The FDA notes that approvals of the vaccine undergo a whole of government approach and acknowledged the urgent need of both vaccines to combat the spread of Dengue and ASF in the country. 'Ina-acknowledge po naman natin yung need for the vaccine and relatively po, fina-facilitate po siya ng FDA as long as there are no standards violated and the safety of the Filipinos who will be inoculated with the vaccine will be assured… Sana pwede ko din sabihin na yesterday yung lead time [sa release ng bakuna], pero sa lalong madaling panahon po sana [ma-approve na],' Teston said. (We are acknowledging the need for the vaccine and relatively, the FDA is facilitating it as long as there are no standards violated and the safety of the Filipinos who will be inoculated with the vaccine will be assured… I hope I can also say that the lead time [fpr the release of the vaccine] was yesterday, but I hope it [gets approved] as soon as possible.) —RF, GMA Integrated News
GMA Network
3 days ago
- GMA Network
USAID cuts may cause over 14 million additional deaths by 2030 — study
WASHINGTON — Deep funding cuts to the US Agency for International Development and its potential dismantling could result in more than 14 million additional deaths by 2030, according to research published in The Lancet medical journal on Monday. WHY IT'S IMPORTANT President Donald Trump's administration, since taking office in January, has made funding cuts to USAID and its aid programs worldwide in what the US government says is part of its broader plan to remove wasteful spending. Human rights experts and advocates have warned against the cuts. USAID funding has had a crucial role in improving global health, primarily directed toward low and middle-income countries, particularly African nations, according to the study. BY THE NUMBERS The study estimated that over the past two decades, USAID-funded programs have prevented more than 91 million deaths globally, including 30 million deaths among children. Projections suggest that ongoing deep funding cuts - combined with the potential dismantling of the agency - could result in more than 14 million additional deaths by 2030, including 4.5 million deaths among children younger than 5 years, the study in The Lancet said. Washington is the world's largest humanitarian aid donor, amounting to at least 38% of all contributions recorded by the United Nations. It disbursed $61 billion in foreign assistance last year, just over half of it via USAID, according to government data. KEY QUOTE "Our estimates show that, unless the abrupt funding cuts announced and implemented in the first half of 2025 are reversed, a staggering number of avoidable deaths could occur by 2030," the study said. CONTEXT US Secretary of State Marco Rubio said in March the Trump administration canceled over 80% of all programs at USAID following a six-week review. The remaining approximately 1,000 programs, he said, would now be administered "more effectively" under the US State Department and in consultation with Congress. — Reuters
GMA Network
6 days ago
- GMA Network
CSC: Gov't workers who discriminate vs. HIV patients face sanctions
Government officials and employees who discriminate against persons living with the human immunodeficiency virus (HIV) face disciplinary measures, guidelines by the Civil Service Commission (CSC) showed. In a statement on Friday, the CSC said its Resolution 25000399 provides for the processes and procedures to investigate and prosecute such discriminatory acts and practices. Offenses may be carried out solely or partially against a person who may be perceived, suspected, or actually has HIV. The guidelines also classifies discriminatory acts according to location, namely the workplace, learning institution, and hospitals and health institutions. According to the CSC, some discriminatory practices may include the following: Restriction on travel and habitation Restrictions on shelter Prohibition from seeking or holding public office Exclusion from credit and insurance services Denial of burial services Acts of bullying "The new rules shall apply to all officials and employees in all branches and agencies of the government, including national government agencies, local government units, state colleges and universities, and government-owned and controlled corporations with original charters," the statement read. READ: Cover Story | Overcoming HIV: Hope Rises Between Two Red Lines Cases of discrimination will be handled in accordance with the 2017 Rules on Administrative Cases in the Civil Service, Republic Act 11166 and its Implementing Rules and Regulations. Earlier, the DOH requested for a national declaration of public health emergency for HIV following a 500% increase in the number of young Filipinos diagnosed with the infection. Herbosa had said HIV was currently a bigger health problem than mpox or monkeypox, expressing fears that the number of infections would soon hit 400,000. — VDV, GMA Integrated News
