Latest news with #HIV-negative
India Today
2 days ago
- Health
- India Today
Lenacapavir becomes first FDA-approved HIV preventive drug: All about it
In a major breakthrough in the fight against HIV, the US Food and Drug Administration (FDA) has approved lenacapavir, under the brand name Yeztugo, a long-acting injectable drug developed by Gilead Sciences, as a preventive treatment for HIV. It has been in the making for over two for HIV prevention is not approved by any regulatory authority outside the US. There is currently no cure for HIV or makes Yeztugo the first and only HIV pre-exposure prophylaxis (PrEP) option in the United States that is required just twice a year. The injectable drug is approved for use in adults and adolescents weighing at least 35 kg who are at risk of acquiring HIV through sexual trial data show over 99.9% of people who received Yeztugo remained HIV-negative during the study period, highlighting its strong potential to prevent HIV infections.'This is a historic day in the decades-long fight against HIV. Yeztugo only needs to be given twice a year and has shown remarkable results. It could transform HIV prevention,' said Daniel O'Day, CEO of Gilead FOR HIV PREVENTIONThe first PrEP medication, also made by Gilead, was approved in 2012. But as of 2022, only about 1 in 3 people in the US who were eligible for PrEP were actually prescribed it, according to the Centers for Disease Control and Prevention (CDC).advertisementMany people, especially women, Black and Latino communities, and people in the US South, continue to face challenges such as stigma, lack of awareness, and difficulties in sticking to daily oral medications.'Yeztugo could be the transformative option we've been waiting for. A twice-yearly shot could help overcome key barriers like adherence and stigma,' said Dr. Carlos del Rio, Professor of Medicine at Emory YEZTUGO WORKSYeztugo contains lenacapavir, a unique antiretroviral that works by blocking HIV (Human Immunodeficiency Virus) at multiple stages of its life cycle, unlike most drugs that target just one. The injectable drug is approved for use in adults and adolescents weighing at least 35 kg who are at risk of acquiring HIV through sexual contact. () It is not a complete treatment for people who already have HIV, and people must be tested for HIV before starting the company has also highlighted certain safety warnings of the drug:People must be confirmed HIV-negative before starting or continuing Yeztugo. Taking it unknowingly while already infected with HIV can lead to drug-resistant strains of the side effects include injection site reactions, headache, and the drug stays in the body for up to 12 months, missed doses or improper use can increase the risk of infection and drug should not be used by individuals who are HIV-positive or whose status is IT'S GIVENYeztugo is given as a subcutaneous injection every six months, but starts with a loading dose that includes two injections and oral a patient misses a scheduled injection, temporary oral tablets may be taken weekly until injections TRIAL SUCCESSThe FDA approval is based on two large Phase 3 trials, led by researchers from Emory University and Grady Health 1 Trial: Conducted in cisgender women in sub-Saharan Africa, this trial showed zero HIV infections among the 2,134 people who received Yeztugo, demonstrating 100% effectiveness compared to daily oral PrEP (Truvada).PURPOSE 2 Trial: Involved cisgender men and gender-diverse people across various countries. Out of 2,179 participants, only two HIV infections were recorded in those on Yeztugo, showing 99.9% effectiveness. Yeztugo is given as a subcutaneous injection every six months, but starts with a loading dose that includestwo injections and oral tablets. () advertisementBoth trials found Yeztugo to be superior to daily oral PrEP and it was generally well-tolerated, with no new safety light of this breakthrough, the peer-reviewed journal Science named lenacapavir its 2024 "Breakthrough of the Year."MAKING IT WIDELY ACCESSIBLE IN THE USTo make Yeztugo widely accessible, Gilead is working with insurers and health systems to include the drug in insurance uninsured individuals, Gilead's assistance program will provide Yeztugo free of cost, based on EXPANSION PLANSGilead has already filed for regulatory approval in Australia, Brazil, Canada, South Africa, and submitted applications to the European Medicines company is also preparing applications in countries like Argentina, Mexico, and Peru, which rely on FDA approvals for their own of now, Yeztugo is only approved in the United States for HIV prevention. There is no cure for HIV or AIDS, but preventive tools like Yeztugo bring the world closer to controlling the this FDA approval, the drug can help those who have struggled with traditional prevention methods, making the prevention more manageable.
Time Magazine
3 days ago
- Health
- Time Magazine
FDA Approves a Twice-Yearly Shot to Prevent HIV
On June 18, the U.S. Food and Drug Administration (FDA) approved the first medicine to prevent HIV that only has to be taken twice a year. People who are at high risk for HIV can now take the injection—called lenacapavir and sold as Yeztugo—just once every six months. The approval is a milestone in the fight against HIV and could transform the epidemic. While anti-HIV drug treatments have helped millions of people suppress the virus to undetectable levels so that they don't spread it to others—and have also allowed people who are HIV-negative to maintain their status when used to prevent infection—a regimen of daily pills means that compliance, and therefore effectiveness, is often not as strong as it should be. In two studies, scientists at Gilead, which developed lenacapavir, showed that the drug was 96% effective at protecting cisgender women from becoming HIV positive as compared to daily oral pills (called PrEP, short for pre-exposure prophylaxis). In men who have sex with men and gender-diverse people, the drug was 100% effective. 'Lenacapavir used by itself for prevention is a huge breakthrough,' says Dr. David Ho, professor of microbiology, immunology, and medicine at Columbia University who pioneered combining anti-HIV drugs to suppress the virus and its ability to mutate to become resistant to treatment. 'Its potential is great in curtailing the epidemic.' But advocacy groups and global AIDS organizations raise concerns about whether that potential will be fully realized, given recent cuts to U.S.-supported programs for HIV treatment and prevention around the world. From treatment to prevention Lenacapavir was approved by the FDA in 2022 to treat people with HIV whose virus has become resistant to other antiviral drugs. As they were developing that treatment, Gilead's scientists noticed that lenacapavir had two important properties that could make it potentially useful in preventing HIV as well: its ability to remain in the body for a longer time than other antiviral drugs, and its power to interfere with several steps in the process that the virus uses to make copies of itself. 'We observed a fantastic effect after a single injection," says Tomas Cihlar, senior vice president of virology at Gilead. "Basically, it protected non-human primates from acquiring HIV. That's when we realized we really needed to get full speed and full force behind the prevention idea.' But because people taking a drug to prevent infection are HIV negative, 'the bar for safety for people who don't have the disease is quite high,' says Jared Baeten, vice president of HIV development at Gilead. 'Still, based on all the pharmacology, science, and demonstrated antiviral activity and safety in the HIV treatment sphere, by the end of 2020 we made the decision to move lenacapavir into prevention,' he says. While it's the same drug, when doctors use lenacapavir to treat HIV, they often combine it with other drugs to limit HIV's potential for developing resistance. But to prevent disease in people who are HIV negative, lenacapavir can be used alone, since there isn't already an actively reproducing population of virus in the body. How lenacapavir could quash HIV vaccine efforts Lenacapavir is not an HIV vaccine, but its effect in preventing infection is similar to one. Vaccines enlist and train the immune system to recognize and target pathogens like viruses, so the body becomes a factory for generating the appropriate defenses to fight infections. Lenacapavir's ability to fend off infection comes from having circulating levels of the drug in the body to fight off any virus that might enter. Whether it's the immune system or the drug, the effect is very similar—which is a huge advance. In the more than 40 years since HIV was discovered, scientists have not been able to develop a vaccine against it. 'So far the candidate vaccines do not show this kind of promise for preventing HIV infection,' says Ho. 'We're nowhere close to an efficacious vaccine.' With lenacapavir approved to prevent HIV, the bar for developing a vaccine becomes even higher. It could be ethically difficult to justify asking people to take a placebo to establish the effects of a vaccine, since both oral PrEP and now lenacapavir as PrEP are so effective in protecting against HIV infection. Depriving those in a vaccine trial from taking lenacapavir by assigning them to receive a placebo would be problematic. 'This might take a bit of the wind out of the sails of vaccine research, because there is something so effective at preventing HIV infection,' says Ho. The future of HIV treatment and prevention The long-acting nature of lenacapavir represents a new direction for anti-HIV drugs that could make preventing infections more tenable and accessible to more people, says Hui Yang, head of supply operations of the Global Fund to Fight HIV, TB, and Malaria. 'We learned from decades-long experience that in prevention programs, adherence is a big issue. And that is an aspect we are hoping to address with the introduction of lenacapavir for PrEP.' The Global Fund's goal is to get two million more people in prevention programs over the next three years, and lenacapavir could accelerate reaching that target. But the shot still must be administered by a health care provider, and people need to test negative for HIV before receiving each shot. Those are hurdles for many of the most vulnerable populations in low- and middle-income countries, many of whom are young adults. To further increase access, Yang says, a form of lenacapavir that people could inject themselves with twice a year would be even more appropriate for such settings. 'It could become something like an insulin injection that people can do themselves,' she says. Gilead is working on a once-a-year version of lenacapavir that would cut down on the need for multiple clinic visits. The unrealized potential of lenacapavir While the advance is scientifically exciting, the drug may take years or even decades to significantly curb the global HIV epidemic. 'We just built the best plane in the world, but unfortunately tore up all the runways,' says Kevin Frost, CEO of amfAR, the Foundation for AIDS Research. 'Lenacapavir is coming at the worst moment in the last 30 years of the AIDS epidemic. We are seeing ourselves time traveling back decades because of the dismantling of the infrastructure around the treatment and prevention of HIV." Cuts to USAID, PEPFAR, and the National Institutes of Health "mean lenacapavir will never have a shot coming out of the gate. The very architecture that could deliver lenacapavir on a global scale to be transformative is being dismantled." While Gilead would not specify a price for lenacapavir, a company spokesperson said it would likely be 'in line with existing branded PrEP options.' Still, that could be out of reach for those in lower income countries who could benefit the most, says Frost. Addressing cost and other issues related to access will be critical to realizing the full potential of the drug. In the U.S., states that offer and cover PrEP options have reported a 38% decrease in new infections, whereas states that don't make PrEP as available saw a 27% increase in infections from 2012 to 2022, according to a recent report published in the Lancet HIV. Gilead has negotiated royalty-free licensing deals with six generic manufacturers to manufacture lenacapavir for prevention for 120 low- and middle-income countries. 'Hopefully in those places where they have that kind of manufacturing capacity, we will see cheap, inexpensive lenacapavir," says Frost—but given that the normal distribution channels are newly gutted programs like USAID and PEPFAR, "I still expect access will be extraordinarily limited.'
9 News
4 days ago
- Health
- 9 News
Rule change means gay and bisexual men can donate plasma without wait times
Your web browser is no longer supported. To improve your experience update it here LIVE Rockets activate third country's air defences Sexually active gay and bisexual men will be able to donate plasma under a change in rules by Australian Red Cross Lifeblood. Under the previous rules, any gay or bisexual men and transgender women who have sex with men cannot donate blood or plasma if they have had sex in the last three months. But from July 14, Lifeblood will remove most sexual activity with times for plasma donations for gay and bisexual men and transgender women, meaning they can donate plasma at any time. Sexually active gay and bisexual men will be able to donate plasma in a change of rules. (Lifeblood) It means over 100,000 additional people can donate much-needed life-saving plasma, Lifeblood said. "We're excited to be able to welcome more people from across the community into our donor centres from next month," Lifeblood's chief medical officer Dr Jo Pink said. "With more than 600,0000 people estimated to be covered by the previous wait times, we now anticipate an extra 24,000 donors and 95,000 extra donations of plasma to be made each year." They will also accept plasma donations from people taking PrEP, an antiviral taken by people who are HIV-negative that protects them from contracting the illness. The Therapeutic Goods Administration (TGA) has also approved a submission to remove gender-based sexual activity rules from blood and platelet donation eligibility. The change means all people with a single sexual partner for six months or more will be eligible to donate blood. It means over 100,000 additional people can donate much-needed life-saving plasma, Lifeblood said. (9NEWS) Most people with new or multiple partners will also be able to dontate blood under the new laws, as long as they haven't had anal sex in the past three months. The rule change means men will not be asked if they have had sex with another man but rather everyone will be asked the same questions regardless of their gender or sex. "This is a significant milestone in being able to safely reduce wait times and make it easier for more people in the LGBTQIA+ community to donate," Pink said. "Blood safety is and always will be our top priority, but we know the current donation rules have been very difficult for many people in the LGBTQIA+ community. "While they were put in place to ensure a safe blood supply in the past, we know that they've contributed to the stigma faced by the community. "We hope as we move through the process of seeking to have both these changes introduced, that this will be a turning point for both Lifeblood and the LGBTQIA+ community." People taking PrEP still won't be able to donate blood despite the changes. CONTACT US
Time of India
28-05-2025
- Health
- Time of India
Kin of girl who contracted HIV during blood transfusion being compensated, state govt tells Kerala high court
Kochi: The state govt has informed high court that an order has been issued sanctioning appropriate financial aid to the father of a nine-year-old girl who allegedly contracted HIV during a blood transfusion at the Regional Cancer Centre (RCC), Thiruvananthapuram, and died in 2018. Tired of too many ads? go ad free now Health and family welfare additional chief secretary Rajan Khobragade submitted in an affidavit that necessary instructions had also been issued to the revenue (disaster relief fund) department to take further steps for disbursing the financial assistance from the chief minister's disaster relief fund (CMDRF) on an urgent basis, vide order dated May 12. The affidavit was filed in response to a petition submitted by the girl's father, seeking adequate financial aid to help the family cope with the mental trauma caused by the child's untimely death and to relieve the financial burden from prolonged medical treatment. The girl, initially suspected to be suffering from leukaemia, was treated at the Medical College Hospital, Alappuzha, and later referred to RCC. She underwent 49 blood transfusions during her treatment. According to the petitioner, one of the blood donors was later found to be HIV-positive. He alleged that his daughter, who was HIV-negative at the start of treatment, contracted the infection during her treatment at RCC. However, the affidavit stated that RCC was of the considered view that the child and her family were provided full medical, psycho-social and emotional support throughout the unfortunate episode and that no lapses could be attributed to the RCC. The RCC had not recommended compensation, contending that the cause of death was not HIV infection. It was also submitted that RCC does not maintain any funds for compensating deaths or accidents arising from contingent events linked to the institution. Tired of too many ads? go ad free now The affidavit also included technical details regarding the current blood testing equipment used at RCC, highlighting the advancements in technology, including the make, model, and its superiority over the equipment in use at the relevant time.
Daily Mail
28-04-2025
- Health
- Daily Mail
Scientists discover disturbing 'unexpected' side effect of new mRNA jab
Patients given experimental mRNA jabs for HIV have developed an 'unexpected' side-effect needing further investigation, experts say. About 7 per cent of volunteers given the jabs in the trial broke out in an itchy bumpy rash called hives. While this rash disappeared for some sufferers, over half were still experiencing bouts a year after injection. Some were still breaking out in hives almost three years after receiving the jab. Experts analysing the data noted volunteers who suffered the hive reaction were more likely to have received the Moderna mRNA Covid vaccine in the past. However, they added this finding didn't necessarily mean the two are linked and how and why the new jabs were provoking this reaction remained unclear. The reaction was seen across a trio of potential HIV jabs manufactured by Moderna with the same mRNA technology famously used in Covid vaccines. These jabs were tested on a group of 108 HIV-negative volunteers to measure their overall safety. Volunteers were split into three groups, each receiving one of the three different vaccine formulas. These groups were then split further into a high-dose or low-dose cohort for a total of six different cohorts. After the initial injection repeat doses were administered at 12 weeks and then again at 24 weeks. In their report experts from the University of Pittsburgh found the jabs to be 'generally safe and tolerable'. However, they noted the hive reaction in seven participants — seen across all three vaccine formulas— was an 'unexpected' result. Writing in the Annals of Internal Medicine, they said what was causing the hives in some people was unclear. But they theorised it could be due to a combination of vaccine components, the dosage, and an unknown environmental factor. The scientists said while mRNA vaccine technology continued to hold great promise, further research was needed into what was causing this hive reaction. Independent experts, writing in a linked editorial, agreed. They said that while hives is, overall, a minor ailment it can still contribute to vaccine hesitancy and hinder vaccine uptake. The experts said more work was needed to understand the mechanisms behind the reaction 'to ultimately promote the safety and uptake of vaccines'. There is currently no cure for HIV, which affects approximately 100,000 Britons and 1.2million Americans. Although there are prevention drugs, they need to be taken daily. WHAT IS HIV? HIV (human immunodeficiency virus) is a virus that damages the cells in your immune system and weakens your ability to fight everyday infections and disease. AIDS (acquired immune deficiency syndrome) is the name used to describe a number of potentially life-threatening infections and illnesses that happen when your immune system has been severely damaged by the HIV virus. While AIDS cannot be transmitted from 1 person to another, the HIV virus can. There's currently no cure for HIV, but there are very effective drug treatments that enable most people with the virus to live a long and healthy life. With an early diagnosis and effective treatments, most people with HIV will not develop any AIDS-related illnesses and will live a near-normal lifespan. Source: NHS A vaccine that offers lifetime protection from the virus would be a breakthrough for the disease that has claimed millions of lives. But despite 40 years of research since HIV was first identified, a vaccine has been elusive, with half-a-dozen real-world trials repeatedly failing to deliver on initial results. HIV is a virus that damages the cells in your immune system and weakens your ability to fight everyday infections and disease. AIDS is the name used to describe the potentially life-threatening infections and illnesses that happen when your immune system has been severely damaged by HIV. While AIDS cannot be transmitted from one person to another, the HIV virus can. There's currently no cure for HIV, but there are extremely effective treatments. With an early diagnosis most people with HIV will not develop any AIDS-related illnesses and will live a near-normal lifespan. Currently health officials focus on measures like encouraging safe sex and providing patients medications that stop HIV from spreading. HIV is estimated to have claimed over 40million lives since it first emerged. While new HIV diagnoses in the UK had been trending down for years, there has been a recent surge of new cases. In 2023, there were just over 6,400 HIV diagnoses in the UK, a 46 per cent increase compared to the year before. Health officials have said the wave of new cases could be a sign of ongoing transmission or a reflection of migration bringing more people with HIV into the country.
