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HIV treatment breakthrough

New experimental injection could revolutionise treatment

Scientists have developed a new therapy for HIV/AIDS that they say could lead to longer periods of pill-free treatment and even eventually, perhaps, to what experts call a “functional cure”.

Researchers at Taiwan-based United BioPharma report encouraging results with a single injection that seems to check HIV as well as daily pill regimens.

A report on their study published in a the New England Journal of Medicine this April says the results add to a growing number of studies suggesting that patients may be able to take pill holidays without putting their health at risk.

Currently, patients have to take combinations of medications keep the virus under control and not damaging their immune systems, which could lead to more serious, fatal outcomes.

“Therefore, the patients’ greatest struggle is contending with the daily regimen of pills, unappreciated long-term toxicity and stigma. These can impact a patient’s quality of life,” said says Chang-Yi Wang, chief scientific officer and chairperson of the company and lead author of the study.

The patients must also adhere to a strict medication regime. Missing a dose of the pills, they are warned, can give the virus the chance to develop resistance to the drugs and lead to a surge in new copies of HIV that flood the body.

Wang said there are several benefits to antibody drugs.

“One, antibodies have long half-lives and can be administered with less a frequent dosing schedule, such as … weekly, semi-monthly or even monthly,” Wang said. “Two, biological protein drugs have lower toxicities to the liver, kidneys, etc. And three, certain antibody drugs, such as UB-421, can exhibit beneficial immunomodulatory effects that cannot be achieved by small molecule drugs.”

The HIV knock-out

The new therapy involves an injectable monoclonal antibody called UB-421 which promises to keep the virus in the patient’s blood stream below-detectable levels. The UB-421 anti-body is designed to stick to the same site on immune cells that HIV uses to infect cells; the idea is that UB-421 would compete with HIV and occupy more of these sites, preventing the virus from entering and infecting new cells.

In fact, UB-421 binds to immune cells with 50 to 100 times greater affinity than HIV does and can even knock HIV out of the entry site when the virus is already there.

“We were able to use this antibody to maintain durable viral remission using a single agent instead of a cocktail of drugs,” says Chang-Yi Wang, chief scientific officer and chairperson of the company and lead author of the study. “Such a durable maintenance is unprecedented, and it opens up a host of potential new treatment options for patients with resistance-prone HIV infection.”

The study is a first step toward making it possible for patients to move away from daily pill treatments and rely on longer term control of the virus.

The researchers plan to study UB-421 next in people who have been recently diagnosed with HIV but are not yet taking medications; they will see if the shot can control the virus for up to six months.

Wang is hopeful that the results will be positive. Already, further analysis of the data from the current study suggest that longer remissions may be feasible.

Not only did the antibody UB-421 block HIV from infecting new cells, but it also seemed to modify the study participants’ immune cells in ways that made them better able to fight off the virus. UB-421 seemed to activate certain immune cells to better recognize and destroy HIV, including the hard-to-reach reservoirs where the virus tends to hide from immune cells.

“We think [UB-421] could be a great agent in future studies for activating T cells to do many things, including cleaning the body of virus,” she says.

If the immune system can be retrained to better ward off HIV, that could lead to longer and longer periods of pill-free treatment and even eventually, perhaps, to what experts call a functional cure for HIV — should UB-421 allow patients go years with undetectable HIV levels without needing pills or repeated antibody injections.

“We don’t know exactly what passively transferring antibodies is doing,” says Dr. Anthony Fauci, director of the National Institute on Allergy and Infectious Diseases, which partially supported the study. “But there is something going on to induce at least partially — not perfectly — better immune responses than the body naturally makes against the virus.”

Fauci notes that UB-421 works by mimicking the door on immune cells that HIV uses to enter and infect. Fauci and other researchers are also studying antibodies, called broadly neutralizing antibodies, that bind to HIV itself and prevent it from infecting cells. It’s likely that an effective, long-acting and pill-free treatment for HIV may involve a combination of agents like UB-421 and broadly neutralizing antibodies, says Fauci, so that HIV is both crippled and prevented from entering cells.

“Something like that could be a knock-out punch,” he says.

Details of study

In the nonrandomized, open-label, phase 2 clinical study conducted in Taiwan, 29 volunteers with well-controlled HIV were asked to discontinue their normal regimens of daily oral ART pills at the time of their first injection or one week later, depending on their ART regimen.

Fourteen study participants received regular weekly infusions of UB-421, while 15 received higher-dose infusions but once every two weeks. At the end of the 8- or 16-week treatment period, all volunteers restarted their previous ART regimen and were evaluated in follow-up visits up to eight weeks later. Apart from a single participant who discontinued the study because of a mild skin rash, volunteers in both groups maintained HIV suppression (plasma HIV RNA levels under 20 copies/mL) throughout the treatment period in the absence of ART.

This indicates that the injections — in both doses and frequencies — were effectively controlling HIV from replicating further and spreading infection.

Previous experimental infusions of broadly neutralising antibodies (bNAbs) have suppressed HIV for about two weeks by targeting proteins on the virus itself, but the rapid mutation rate of HIV induces antibody-resistant strains that render the treatment ineffective.

UB-421 theoretically avoids this possibility by blocking a stable human protein that HIV uses to infect T cells. Indeed, resistance to UB-421 was not seen in this study. Because the small study did not include a comparator group receiving a placebo infusion, further studies have been planned in Taiwan and Thailand to evaluate the safety and efficacy of UB-421 as a treatment for HIV.

In a related study, scientists at the National Institute of Allergy and Infectious Diseases (NIAID) are currently evaluating the safety of regular infusions of two highly potent bNAbs that may prevent the development of resistant HIV strains by targeting two distinct areas of the virus.

Last year, researchers at the National Institute of Allergy and Infectious Diseases found that short-term ATI did not increase the HIV reservoir size or cause irreversible damage to the immune system, supporting its use to determine the efficacy of ART-free novel therapeutics on virologic suppression.

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32 comments

  1. If this is through then we are very close to the cure of hiv. When will this treatment swing into action by countries

  2. When is this vaccine coming into Nigeria

  3. when is coming into South Africa

  4. Please when is this coming to Ghana, and how can one get from your place to Africa.

  5. Nigerians will be glade to have this soon, when are going to see it?

  6. omok chris opio lab scientists .

    researchere should continue with the work. they are near to the cure now.anly they need is to manufacture UB-450 and compare the action. great step.

  7. A promising achievement, keep working hard scientists

  8. Promising achievement, keep working hard scientists

  9. I hope Ghana with get it very soon

  10. Bring it to kenya

  11. Kulabako yasin salva

    I have liked ur….ABILITY TOWARDS….. What ever u do. If this works out. basing on the reasercher’s, words of analysis then we shall be thru by 80% neerer to cure of HIV cure I Just think. So whn is the beginning of the tests to held on African bloods …I it can also give a result

  12. Muhammad Ilyas

    May i known how and when one can have access to it.?

  13. Keep on working hard guys God is on your side .

  14. Elias Monyeka Kihutwa

    I need that injection please. Am a victim

  15. KWENZAKWENKOSI MAGWAZA

    Bring it to SOUTH AFRICA. I have always maintained that there’s a cure out there.

  16. Hope Africa scientists and our leaders will get the formula and start making it available for all the Africa counties

  17. that’s a cure already,,

  18. Ebenezer Amissah

    Work Hard our dear scientist out there for,there is a cure

  19. There is hope atleast let us hope that it will reach in Africa in the coming few years

  20. There is hope but will this research finished and it comes to africa

  21. Please make sure you send it to Malawi aswell

  22. That’s gud keep on plz

  23. I wish we can also get this drug in Africa especially Nigeria we are having series of cases but because even when one tested positive and identified there is is no access to drugs rather what you face is the stigma hence every one involved we prefer to keep it to its self.

  24. When is it starting in Ugandan save affrica

  25. keep up guys, God will always help those who are hardworking to archive their dreams, and this for God’s family the world………I hope with God’s support, the vaccine will too reach whole African Continent

  26. Simeon Ochieng Asher

    I sincerely thanks the entire team through Wang for having worked around the clock to ensure the study makes a good step that will reduce pill burden to newly infected persons. When will you roll the study in Kenya?

  27. I hope this is a genuine effort. Its a matter of time and effort, we will see HIV gone. It will be a great moment for UGANDA And the entire world.

  28. So many people will never believe in themselves until they die without trying or taking risks, responsibility instead they sit down and look and they will just die like a fool.I was cure of HiV with Herbs by Dr Sebhor.Dr Sebhor Is Real Believe it or not the truth is truthful. Contact him now on email:bemillia25@gmail.com or whatsapp +17182003964 and be free from any kind of diseases. Thanks

  29. That is good to go. When will the vaccine come to Uganda

  30. Thanks to Dr. SAMACO,  the great doctor who help me out of my illness.
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