 Hey everyone, Raif DeRozzi here, and this is another weekly roundup of the latest HIV news for the week of July 24th through July 30th. Today I'll be going through 12 articles covering topics ranging from the EBT-101 CRISPR clinical trial for HIV cure, the benefits of statins on reducing CVD or cardiovascular disease in those living with HIV, how BNABS can lead to HIV cure and or vaccine, the HIV core 006 clinical trial for an HIV vaccine, which countries will see the long-acting injectable cabotegravir rollout, the link between gut health and chronic HIV inflammation, and more. I won't be reading the articles per se but I will give you a brief summary and sometimes I'll throw in my opinion and commentary. If you want access to the complete article, all links will be available in the description box below. Patavastatin lowers risk of cardiovascular events in people living with HIV. A recent study presented at the 12th International AIDS Society Conference 2023 in Brisbane, Australia, revealed that a widely used statin medication, patavastatin reduced the risk of heart attacks, strokes, and other cardiovascular events in people with HIV who were at low to moderate risk for cardiovascular disease. Statins are drugs that help lower LDL or bad cholesterol. The trial, known as the reprieve study, enrolled over 7,700 participants ages 40 to 75, nearly a third were women, 41% were black, 35% were white, and 15% were Asian. The study was stopped ahead of schedule due to promising results. The researchers found that patavastatin lowered the risk of major cardiovascular events by 35%, exceeding their expectations. Statins could potentially prevent up to one in five major cardiovascular events or related deaths in people living with HIV. The study suggests that statin therapy should be recommended for people with HIV to reduce their cardiovascular risk. The Coming Out Party for BNABS, the International AIDS Society Conference showcased groundbreaking research on broadly neutralizing antibodies, or BNABS, as a potential game changer in HIV treatment and prevention. BNABS are special antibodies that can stop various strains of HIV and make it harmless. Researchers are now exploring their use in HIV vaccine development and cure research. The goal is to activate the body's immune system through vaccination, enabling it to produce antibodies that neutralize HIV and prevent the virus from causing harm. If successful, BNABS could be a powerful tool in the fight against HIV offering hope for an effective vaccine in cure. Researchers emphasize the importance of equitable access to these interventions for communities most impacted by HIV worldwide. Once again, as previously mentioned, keep your eye out for mentions of BNABS in terms of HIV cure and HIV vaccine research. Study demonstrates ability to remove key barrier to an HIV cure. Researchers from Emory University presented exciting findings at the International AIDS Conference about the potential of Jack inhibitors, specifically Ruxolitinib, in significantly reducing the HIV viral reservoir in people with HIV. The HIV viral reservoir consists of dormant virus integrated into the genomes of immune cells and poses a challenge for achieving an HIV cure. The phase 2a clinical trial showed an impressive 99.99% clearance of the peripheral HIV1 reservoir in less than three years with Ruxolitinib treatment. The drug also impacted immune activation, cell survival, and immune dysregulation offering hope for cure-based therapies. While more research is needed, these results provide optimism for using Jack inhibitors as part of HIV eradication strategies. African Phase 1 HIV vaccine trial shows encouraging preliminary results. The HIV Core 006 trial conducted in Kenya, Uganda, and Zambia evaluated a novel mosaic HIV vaccine called HIV-Cons-Vx. A mosaic HIV vaccine takes pieces of different HIV subtypes and combines them to induce immune response against a wide variety of global HIV strains. The preliminary analysis showed that the vaccine induced high frequencies of killer T cells, which are highly protective against HIV. These T cells can recognize functionally conserved regions on HIV1, making them effective against multiple HIV strains. The vaccine was well-tolerated by participants with no serious adverse events reported. The trial's goal is to develop an effective HIV vaccine that can protect against HIV strains worldwide. Further analyses and results are expected to be published later this year. DevEx Checkup Who gets the game-changing HIV prevention drug? At the IAS conference, there was much excitement about long-acting technologies, particularly injectable cabotegravir as pre-exposure prophylaxis. Some experts consider it a game-changer due to its convenience, as one injection can provide protection for several weeks. The US Global AIDS Initiative, PEPFAR, plans to roll it out in specific countries, but supply constraints are causing delays. Uganda is among the countries on the provisional list, but its inclusion may change. The current anti-gay law in Uganda makes the introduction of this injectable prep timely, as many LGBTQ plus individuals are in hiding due to fear of arrest, making access to services difficult. However, the uncertainty of CABLA supply remains a challenge for its wider implementation. A provisional list of countries who will get access to CABLA through PEPFAR's rollout through 2025 include Eswatini, Kenya, Lesotho, Nigeria, Philippines, South Africa, Thailand, Uganda, Ukraine, Zambia, and Zimbabwe. The drug smugglers keeping HIV patients alive in South Africa. Thousands of HIV-positive undocumented migrants from Malawi living in South Africa face serious challenges accessing antiretroviral therapy due to their illegal status. Non-South African citizens are often denied HIV treatment at public health care institutions, leading some to turn to drug smugglers who supply the medication at high prices. As a result, patients may skip their treatment, leading to a rise in AIDS-related deaths among Malawian patients in South Africa. To address this issue, Malawi's National AIDS Commission has launched a program providing six months' worth of medication at a time to HIV-positive Malawians living outside of the country, aiming to ensure treatment consistency and prevent drug defaulting. Study shows positive outcomes for first three U.S. living HIV to HIV kidney transplant donors. A recent study published in the Lancet Regional Health Americas suggests that people living with HIV who donate a kidney to other people living with HIV have a low risk of developing end-stage kidney disease, or ESKD, or other kidney problems in the years following the donation. The study was conducted with three donors who underwent living donor HIV to HIV kidney transplants and were monitored for two to four years post-transplant. The findings provide evidence that donating a kidney can be safe for people with HIV and may encourage more HIV-positive individuals to consider living donation, providing more organs for HIV to HIV transplants, and potentially saving lives. Larger and longer studies are still needed to fully understand the lifetime risk of ESKD or end-stage kidney disease in people living with HIV who become living donors. The key to preventing HIV progression may lie in the gut. A new study by University of Pittsburgh suggests that restoring and improving gut health could be crucial in slowing HIV progression. The research performed with simian immunodeficiency virus, SIV, the monkey form of HIV, revealed that simply targeting systemic immune activation and inflammation is not effective in controlling disease progression. They found that virus suppression calmed immune activation and inflammation, but it did not restore them to pre-infection levels. As many of you know, even while virally suppressed, our bodies face chronic inflammation from latent HIV reservoirs. It goes on to say that treatments should focus on healing the gut, as the virus damages immune cells in the intestines, leading to gut dysfunction and systemic inflammation. The study suggests that therapies aimed at preserving gut integrity might help avoid complications and premature death in people living with HIV. Further research is needed to fully understand the mechanisms responsible for gut damage in HIV and explore potential interventions like diet, probiotics, and gut microbial transplants. So yeah, this is really interesting to me too because I've always had gut issues, but noticeably, since I had my HIV diagnosis, progressively over time I feel like my gut issues have slowly gradually gotten worse, especially when it comes to gas. I have a lot of gas as it is, but over time it has definitely gotten worse and worse and worse. So and I'm currently considering talking to my doctor about switching to Descovy, the latest two drug combination ARV, and go off of Victoria to see if maybe that has an impact, but we shall see. But for those of you who are concerned about nutrition and diet and supplements and health, consider doing things that are going to help your gut health, eating healthy, probiotics, prebiotics, things that are like live cultures, like yogurt, things like that might be a benefit. Hopefully they'll come out with more research that can give us more specifics on this because this is really interesting to me. How a drug maker profited by slow walking and promising HIV therapy. Gilead Sciences, one of the world's largest drug makers, is facing allegations and delaying a potentially safer HIV drug to maximize profits. In 2004, Gilead stopped pursuing the new drug, which was an updated version of the existing tenofovir used to treat HIV, claiming it wasn't different enough from the previous version. However, internal documents reveal the company's strategy to prolong the monopoly on its patent protected drugs by delaying the new version's release until shortly before existing patents expired. This tactic, known as product topping, allows company to switch patients to newer patented versions just before a generic competition arrives, keeping prices high. The delayed release of the new HIV treatment is now the subject of state and federal lawsuits as patients claim Gilead unnecessarily exposed them to kidney and bone problems. So to explain this a little bit more, if that was kind of difficult to understand, drug hopping, as an example, if I'm a pharmaceutical company and I have drug A, and I have a patent on drug A for 10 years, so no other companies can make a generic version of this for 10 years. I have that monopoly on the industry. Now, while drug A is out, I might come up with drug B, which is an improvement. And so in the second year that drug A is out, I've got drug B. Well, instead of releasing drug B, I'm going to wait, because if I release drug B in that second year that drug A has been out, then effectively, I've got 10 years of drug A patent, and then 10 years of drug B patent starting in that second year of drug A. So for a total, I have 11 years of patented drugs. However, if I release drug A, it's got a 10 year patent, and then I wait until the ninth or 10th year, right before that patent expires and then generics can flood the market, then I can release drug B on that ninth or 10th year and extend it another nine or 10 years of a patent on that new drug. So then combined, you've got maybe like 19, 20 years of patent instead of just 10 or 11. Had you done it the first way? That's what drug hopping is. I understand why a company would do it. Obviously, it gives them profits. There's moral concerns there, of course, and it's a shame if that newer drug would have been able to prevent bone mineral density loss and kidney problems in people who didn't have access to that drug because of their drug hopping practices. These are just allegations at the time. I think something like this is, I would imagine, is fairly difficult to prove. So we'll see how this plays out and what we learn. Okay, so this next one isn't actually an article. It's an email chain that I was a part of. And the email is from Elliot Weinstein, a doctoral candidate at the University of Miami. He wrote, I'm reaching out to request help recruiting for an exciting dissertation study focused on psychosocial issues related to HIV prevention in aging sexual minority men. This important and growing community is typically underrepresented in research studies and the current project aims to address this gap in the literature. The project is called SMASH, or the Sexual Minority Aging and Sexual Health Study. This project is funded by the National Institute on Drug Abuse and is co-led by me and my mentor, Dr. Stephen Saffron, at the University of Miami. We are hoping to recruit older, meaning 55 to 80 years old, HIV negative and or HIV status unknown, sexual minority men, gay, bisexual, or other men who have sex with men living in the state of Florida. Participants would be compensated $35 for completing a one-time online or in-person psychosocial assessment battery. The link to the short eligibility screener can be found in the description box below. If you are HIV negative or you don't know your status or you know someone who is HIV negative and is in that age range of 55 to 80 and is a minority, then check out the link, share it with someone who fits that description as well. Uganda anti-gay law already causing harm, says US ambassador. The controversial anti-gay bill signed into law by Ugandan president Yowari Musavini is already having detrimental effects on HIV response in the country. US officials and HIV activists are concerned that the law, which prescribes the death penalty for aggravated homosexuality, will impact access to medical care and hinder organizations from providing HIV prevention and treatment services. LGBTQ plus communities are facing discrimination, denial of treatment in some health centers and threats of reporting to the police. Many have gone into hiding and stopped seeking healthcare, putting the gains made in the fight against HIV and jeopardy. The US president's emergency plan for AIDS relief, PEPFAR, is taking measures to protect clients and health workers, including providing services directly to clients and enhancing security at drop-in centers. The law is now being reviewed for its constitutionality in Ugandan court. And for our last article, EBT 101 receives FDA fast-track designation, what it means and how it works. Researchers at Cooper Medical School of Rowan University are conducting a groundbreaking clinical trial to evaluate EBT 101, a CRISPR-based gene therapy aimed at removing HIV-proviral DNA from infected cells to potentially cure HIV. Excision biotherapeutics is sponsoring the trial, which is the first attempt in medical history to use gene editing to eliminate a viral infection from a patient's cells as a potential cure. The trial will enroll nine participants, and Cooper is one of only three sites participating in the study. I will work on developing a video that goes more in depth into this clinical trial because I think there's a lot more to discover and I'm sure you all are interested, so stay tuned for that. You can find links to all these articles in the info box below this video. 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