#hiv drug

[reasonsforhope]

"A large clinical trial in South Africa and Uganda has shown that a twice-yearly injection of a new pre-exposure prophylaxis drug gives young women total protection from HIV infection.

The trial tested whether the six-month injection of lenacapavir would provide better protection against HIV infection than two other drugs, both daily pills. All three medications are pre-exposure prophylaxis (or PrEP) drugs.

Physician-scientist Linda-Gail Bekker, principal investigator for the South African part of the study, tells Nadine Dreyer what makes this breakthough so significant and what to expect next.

Tell us about the trial and what it set out to achieve

The Purpose 1 trial with 5,000 participants took place at three sites in Uganda and 25 sites in South Africa to test the efficacy of lenacapavir and two other drugs.

Lenacapavir (Len LA) is a fusion capside inhibitor. It interferes with the HIV capsid, a protein shell that protects HIV’s genetic material and enzymes needed for replication. It is administered just under the skin, once every six months.

The randomised controlled trial, sponsored by the drug developers Gilead Sciences, tested several things.

The first was whether a six-monthly injection of lenacapavir was safe and would provide better protection against HIV infection as PrEP for women between the ages of 16 and 25 years than Truvada F/TDF, a daily PrEP pill in wide use that has been available for more than a decade.

Secondly, the trial also tested whether Descovy F/TAF, a newer daily pill, was as effective as F/TDF...

The trial had three arms. Young women were randomly assigned to one of the arms in a 2:2:1 ratio (Len LA: F/TAF oral: F/TDF oral) in a double blinded fashion. This means neither the participants nor the researchers knew which treatment participants were receiving until the clinical trial was over.

In eastern and southern Africa, young women are the population who bear the brunt of new HIV infections. They also find a daily PrEP regimen challenging to maintain, for a number of social and structural reasons.

During the randomised phase of the trial none of the 2,134 women who received lenacapavir contracted HIV. There was 100 percent efficiency.

By comparison, 16 of the 1,068 women (or 1.5%) who took Truvada (F/TDF) and 39 of 2,136 (1.8%) who received Descovy (F/TAF) contracted the HIV virus...

What is the significance of these trials?

This breakthrough gives great hope that we have a proven, highly effective prevention tool to protect people from HIV.

There were 1.3 million new HIV infections globally in the past year. Although that’s fewer than the 2 million infections seen in 2010, it is clear that at this rate we are not going to meet the HIV new infection target that UNAIDS set for 2025 (fewer than 500,000 globally) or potentially even the goal to end Aids by 2030...

For young people, the daily decision to take a pill or use a condom or take a pill at the time of sexual intercourse can be very challenging.

HIV scientists and activists hope that young people may find that having to make this “prevention decision” only twice a year may reduce unpredictability and barriers.

For a young woman who struggles to get to an appointment at a clinic in a town or who can’t keep pills without facing stigma or violence, an injection just twice a year is the option that could keep her free of HIV.

What happens now?

The plan is that the Purpose 1 trial will go on but now in an “open label” phase. This means that study participants will be “unblinded”: they will be told whether they have been in the “injectable” or oral TDF or oral TAF groups.

They will be offered the choice of PrEP they would prefer as the trial continues.

A sister trial is also under way: Purpose 2 is being conducted in a number of regions including some sites in Africa among cisgender men, and transgender and nonbinary people who have sex with men.

It’s important to conduct trials among different groups because we have seen differences in effectiveness. Whether the sex is anal or vaginal is important and may have an impact on effectiveness.

How long until the drug is rolled out?

We have read in a Gilead Sciences press statement that within the next couple of months [from July 2024] the company will submit the dossier with all the results to a number of country regulators, particularly the Ugandan and South African regulators.

The World Health Organization will also review the data and may issue recommendations.

We hope then that this new drug will be adopted into WHO and country guidelines.

We also hope we may begin to see the drug being tested in more studies to understand better how to incorporate it into real world settings.

Price is a critical factor to ensure access and distribution in the public sector where it is badly needed.

Gilead Sciences has said it will offer licences to companies that make generic drugs, which is another critical way to get prices down.

In an ideal world, governments will be able to purchase this affordably and it will be offered to all who want it and need protection against HIV."

-via The Conversation, July 3, 2024

[torchflies]

Okay guys, I'm still drowning at work but here’s something good that's been keeping my head above water 🤣: retired rockstar Tom “Iceman” Kazansky. 

Ice is born to a pair of early hippies in VW Kombi bus painted with all the colors of the rainbow. He gets his first modeling gig after he's scouted at a Janis Joplin show on his Daddy’s shoulders, before or after Big Brother and the Holding Company. 

Anyway, fact is that baby Ice ends up with his face plastered all over everything from Camels ads to diapers. He eventually ends up doing commercials and then bit parts on TV shows and movies. He does Disney for a good long while, with Bobby Driscoll levels of success. But by the time the mid-70s roll around — teenage Ice is the frontman of a heavier crossed with glam rock sorta band: think Def Leppard, Kiss or even Mötley Crüe (way before their time on the Sunset Strip). 

Ice can sing just about anything the band needs him to — think Adam Lambert's levels of range, just straight-up incredible. He's tatted up from dick to tits and has tried just about every drug known to man by the time he's nineteen, starved himself for years, and spends every hour of his life pandering to people who don't give a shit about him.

At twenty-two he realizes that he doesn't even like himself anymore. He doesn't know who he is without being Kairo Jett (his stage name). 

Then, his friends start dying. 

It’s 1981, and sure they were occasionally dying before — booze, drugs or taking their own lives — but now they're all dying of something that doesn't have a name and he's terrified. 

So, he quits and runs away to a life of structure that he's never had. He runs to the USNA, dyes his hair bleach blond, stops wearing heavy makeup, starts eating again and just becomes Thomas Kazansky — then the Iceman, a new kind of stage name.

The Iceman, who has shared the stage with all the greats of rock music, watches Maverick serenade their instructor in the O Club with one of his old songs and has never been more enamored with anyone in his whole life. 

He falls ass over tea kettle the minute Maverick asks him if he's ever heard of the band Tommy Eats the Drum Kit.

Ice doesn't stop laughing for hours. 

[heartless-aro]

To HIV+ AlloAros:

A lot of alloaros on here have talked a lot about how they face a lot of stigma for wanting to be sexually active while lacking romantic feelings, and how people often stereotype them as uncaring, promiscuous, careless, or irresponsible. I was thinking about this, and it reminded me of some of the sentiments that I’ve heard directed towards people who are HIV+. As such, I would like to take a moment to acknowledge HIV+ alloaros.

To all those allosexual aromantics out there living with HIV, just wanted to say that you are wonderful. You don’t deserve to be stereotyped as reckless or careless or promiscuous or irresponsible, whether you contracted HIV from your first and only sexual partner, from your 30th sexual partner, from IV drug use, or by any other means. You are not wrong or bad or dirty if you have had and enjoyed sex outside of a romantic relationship, even if you are someone who contracted HIV through casual sex. You aren’t “perpetuating stereotypes” (either of alloaro people or HIV+ people) by existing as an HIV+ alloaro. Your sexual feelings are beautiful and natural, and you should never feel ashamed of yourself for having them. You add rich and meaningful perspectives and experiences to the LGBTQ+ community, and we are lucky to have you as part of this community.

I hope that ART works well for you and enables you to live a long, happy life, and enjoy a healthy and active sex life (should you so choose). If you choose to have a zucchini, foveo, FWB, spouse, romantic partner, soft romo partner, or any other sort of partner (or partners!) I hope that they are accepting of your HIV status and that they are able to take PrEP (if needed) with minimal side effects. If sexual intimacy is something that you want, I hope that you and your partner(s) have sex that makes you feel beautiful and sexy and desirable and happy.

I hope that you are able to have children if you so choose, and that your friends and family are accepting of your HIV status.

If you have any symptoms, I hope that they are manageable and that you’re able to continue enjoying the things that make you happy. If you’re struggling with medical trauma due to your HIV treatment experiences, I hope someday you’re able to feel safe seeking medical help again. If you struggle with addiction and contracted HIV due to drug use, then I hope addiction and/or mental health recovery go well for you, should you choose to seek it out.

I hope you’re having a wonderful day, and I hope you have a wonderful life.

(For anyone who has read this far, I’ve added a link below to a list of HIV/AIDS research and relief organizations. Consider donating to one of them if you can!)

[clannadmark]

nigel, the survivor of rabies and chronic addict

she's not just addicted to sweets now. is all i will say.

wanted to change her to be more sickly looking and sorta take some creative liberties with the whole "rabid squirrel" thing, making it more of a disease similar to hiv/aids where if found early can merely be a chronic illness in remission rather than a terminal illness. also she's emo now lmao

[baking-accident]

early rent lore from jonathan larson's notes [x][x][x][x]

[creepyscritches]

Formulating a high level question on the financial side of medicine when my strength lies in clinical and only hearing crickets in the call when I finish like.......am I loudly stupid or does no one have an answer

[woodsfae]

During the randomised phase of the trial none of the 2,134 women who received lenacapavir contracted HIV. There was 100 percent efficiency. By comparison, 16 of the 1,068 women (or 1.5%) who took Truvada (F/TDF) and 39 of 2,136 (1.8%) who received Descovy (F/TAF) contracted the HIV virus.

[angelindiskies]

A bit of my story

[reasonsforhope]

Program led by St. Michael’s Hospital to dispense free HIV self-testing kits, harm reduction, sexual health supplies

“Machines that dispense free self-testing kits for HIV and COVID-19, naloxone kits, new needles, condoms and other essential harm reduction and sexual health supplies will soon appear in communities across Canada.

The ‘smart’ machines, called Our Healthbox, work like a vending machine, and also provide health information and a service directory for people to find much-needed health care and supports in their community. The initiative, led by researchers at St. Michael’s Hospital, a site of Unity Health Toronto, will launch in four communities in New Brunswick on Jan. 23, with plans to launch up to 50 machines across Canada in 2023. The goal is to install 100 machines over the next three years, and to evaluate how well they support people with their health needs...

Providing access to harm reduction and health care supplies for free to people in spaces they frequent is a strategy experts consider as key to reaching people who are underserved and who have barriers to accessing testing, harm reduction materials, treatment, care and prevention due to racism, homophobia, stigma and discrimination.

“Everyone in Canada deserves to have what they need, when they need it, to take care of their health. But we know that this is not the case, and so we are doing everything we can to bridge that gap in ways that work for each person in their community,” said Dr. Sean B. Rourke...

Our Healthbox is the latest phase of work led by Rourke to connect those with complex health and social circumstances to testing, treatment and prevention. In 2019, Rourke spearheaded a cross-Canada clinical trial which evaluated and proved the accuracy of HIV-self tests – Health Canada approved the tests for use in November 2020 based on the results of the trial. In June 2022, Rourke launched the I’m Ready research program, distributing 10,000 free HIV self-testing kits across Canada to reach people who are undiagnosed and get them connected to care, with the goal of identifying the factors that affect access to testing and care.

Rourke and his team will work with local community-based organizations, public health authorities, and health centres to host and maintain the Our Healthbox program.”

-via Unity Health Toronto, 1/23/23

[nokingsonlyfooles]

Global genocide, what a beautiful choice...

In case you missed it - and a golf update seems to have knocked it off the front page - Republicans are threatening to kill millions of people in order to protect "the unborn child." No, not just pregnant women like usual, but men and children - everyone.

The US has been giving HIV/AIDS meds to people who can't afford them, internationally, for about two decades. Most of the institutions distributing these meds are Catholic. Catholics are infamously anti-abortion - to the point of allowing mothers to suffer and die, just like Republicans! This program has a requirement to spend money teaching abstinence - it was penned into law by G. W. Bush! It seems like there shouldn't be a conflict of interest between these two groups, but there is now, and there's a clock ticking down to when these people won't get the meds they need to stay alive.

I suspect our old friend "intellectual property" also has a hand in this situation. It doesn't look like we've spent any money over the last two decades on building infrastructure so these places can make their own damn meds, we just buy them premade and ship them. Actually helping these places manufacture these very expensive drugs would eat into the profits of the pharmaceutical companies that "own" them. It's much better for Gilead there if people just buy drugs and send them. We can just keep doing that forever, right? It's good PR!

Well, now we're in a position where a grandstanding, megalomaniacal political party can hold millions of orphaned children hostage while crowing that they're "saving babies". The Republican solution is that these foreigners should be "responsible" and pay for their own meds... while US companies sit on the patents and jack up the damn prices as high as the market will bear. Yeah, that'll work great.

I've already fled the States. If Democrats can't stop this from happening... You... You can't expect me to keep filling out a ballot and giving you a fig leaf of legitimacy. I found out this year that you didn't even stop stealing children at the border. You can't ask me to keep behaving like it's going to be fine and the system can heal itself if I just keep participating in it. I don't want anything to do with this. I am being dragged kicking and screaming to check a box for people who throw up their hands and refuse to help because, I dunno, maybe this time they might? And then they try to tell me this is my fault, for not being centrist enough.

I dunno what I'm gonna do. I mean, distract myself. Keep redistributing wealth by fair means and foul. And keep yelling about these things. But apart from that...?

[vixvaporub]

Working in healthcare reminds me on the daily that the US medical system is fucked up but a recent example that hasn't escaped my mind for weeks is that a patient with a new diagnosis for HIV was trying to get his medication... but his insurance rejected it and said that they don't cover any HIV meds

[downtonabbeyrewatch2020]

There’s just a lot going on with this episode

[dontmeantobepoliticalbut]

The Food and Drug Administration on Friday proposed easing blood donation guidelines for gay and bisexual men.

Under current rules, the FDA allows donations from gay and bisexual men if they haven't had sex with another man for three months.

In a draft proposal posted to the agency's website, the FDA said the new rules would allow anyone to donate blood — regardless of gender or sexual orientation — as long as they haven't engaged in certain sexual behaviors in the last three months.

That would mean most gay and bisexual men who are in a monogamous relationship with another man will no longer need to abstain from sex to donate blood.

"This is a great first step in getting in the right direction," Dr. Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, said on a call Friday. The new rules, he said, are consistent with those of Canada and the United Kingdom.

Under the new guidelines, blood donors who report having a new sexual partner or more than one sexual partner would be asked about their sexual activity over the last three months.

People taking oral medications to prevent HIV, such as PrEP, and people who have recently had sex in exchange for money or drugs would be subject to a three-month deferral period under the FDA proposal. Those taking injectable PrEP to prevent HIV infection would be deferred for two years from their most recent injection.

People with HIV, including those who take medication that drastically reduces their viral load, would still be asked to not donate blood.

“Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so," FDA Commissioner Dr. Robert Califf said in a statement.

On Friday’s call, Califf said donating blood is “one of several really important symbolic methods of demonstrating one caring for other people.”

The agency's restrictions on blood donations from gay and bisexual men stem from the AIDS crisis, which began in the early 1980s, when little was known about the virus.

As of 2019, an estimated 1.2 million people in the United States had HIV, according to the Centers for Disease Control and Prevention.

Advocacy groups and medical organizations, including the American Red Cross, have urged the FDA to lift restrictions on blood donations for gay and bisexual men, saying the practice is discriminatory and has contributed to shortages in the blood supply in the United States.

A report from the Williams Institute, a think tank at UCLA School of Law, found that if the FDA were to lift donor bans for men who have sex with men, the annual blood supply would increase by 2 to 4%, or 345,400 to 615,300 pints of blood annually.

The FDA is not expected to reach a final decision until after a 60-day public comment period.

Marks, of the FDA, said the agency plans to work with blood collectors during the comment period to help them make any necessary changes needed to implement the new rules.

[fagoutboy]

sorry. still thinking

[med-przemek]

Imperial Lates

Upon experiencing my first Imperial late event, here are a few things that I learnt: 

- My first lecture focused on precision polymer particles by Professor Rachel O’riley. Although typically such nanoparticles are governed by the ratio of hydrophobic and hydrophilic components for self assembly, here; the focus was on crystallisation driven self assembly (CDSA) which overrides this mechanism. DMA seeds are used as the original seeds on which the polymer begins to form through a process known as living polymerisation growth for greater control that leads to platelet like structures. Studying the complexity of assembly was important on exploring how polymer length, composition and chemistry can be altered to rationally tune nanoparticle shape and in turn it’s properties. Novel applications include directing biological interactions, such as cellular uptake, intracellular trafficking and immune response or the ability to modulate hydrogel mechanical and adhesion properties when used as fillers for antimicrobial and tissue engineering purposes. 

- The second talk event was lead by Dr Catherine Kibirige on treating HIV in rural African communities. HIV is particularly difficult to treat and has to be rather suppressed because of it’s elusion from the immune system. Using a continually shifting shield of glycans, it prevent antibodies from detecting and attacking. It also replicates rapidly using reverse transcriptase to develop a pool of diverse HIV strains - called quasi-species - whilst attacking helper T-cells that orchestrate the immune system’s cell signalling. Finally it has a long incubation period and is slow to reveal (typically 5-10 years), where by that point it may have shredded the victims immune system. There are campaigns that have been developed, notably the ongoing UN led campaign of 95-95-95; where 95% people with HIV know their status, then 95% are receiving their treatment and 95% have suppressed their viral load by 2030. Suppression is the best we have at the current moment with no vaccine, with the Undetectable= Untransmittable campaign (U=U), sexual transmissions of HIV can be stopped by lowering the viral load in blood whilst on effective treatment. Dr Kibirige has been a part of the HIVQuant project that is a HIV-1 kit (working on portable solar or battery driven cyclers) that provides a treatment monitoring solution for resource-constrained settings, especially in Africa to minimise monthly hourly trips to district hospitals to meet the 2030 95-95-95 UN target. 

- Vera. AI was the final project that grasped my attention as AI is largely underrepresented in the field of healthcare. Being a hyper-personalised digital platform that focuses on gynaecological, hormonal health management and patient education, this AI tools aims to break women’s health taboos in communicating their medical needs. Focusing on improving patient’s ability to understand and learn, Vera.AI improves patient-doctor communication. This is a project still in it’s early stages but with incorporating ChatGPT in the future, it has colossal potential to democratise women’s health medical data.  

[vamptastic]

a lot of people are being lied to by their parents and teachers and pastors and a lot of people don't want to ever confront that fact. doesn't matter how much access to information has improved, i think the core of the issue is still primarily that people don't feel comfortable with changing their minds, whether it's because it'd isolate them from family, or because they'd have to confront that they were wrong or did something wrong. ive spoken to so many people my age where ive spent hours digging into their misfounded belief, figuring out what misinfo they were told and why, used the internet to firsthand show them exactly what lie they were told and empirical evidence of the truth, and then had them go, yeah, well, i still disagree. i mean, dont automatically assume someone is wrong because they have the same access to info as you and are just stupid, but willful ignorance is definitely still a thing.