HIV News: Another Long-Acting, Injectable Drug CPT31 That Last For 3 Months To Treat HIV Coming Soon.

HIV News: The trend for HIV drug research is now shifting towards drugs with long lasting effects without the need for HIV patients to adhere to stringent daily regimens and doses which can be quiet stressful at times.


 
Scientists from the University of Utah Health in collaboration with researchers from the National Institute of Allergy and Infectious Diseases (NIAID), Beth Israel Deaconess Medical Center in Boston, and Navigen, Inc. have developed an injectable drug that blocks HIV from entering cells. They say the new drug potentially offers long-lasting protection from the infection with fewer side effects.
 
The drug called CPT31, which was tested in non-human primates, could eventually replace or supplement components of combination drug "cocktail" therapies currently used to prevent or treat the virus.
 
The research findings were published in the journal: Proceedings of the National Academy of Sciences (PNAS). https://www.pnas.org/content/early/2020/08/19/2009700117
 
Dr Michael S. Kay, M.D. Ph.D., a senior author of the study and a University of Utah Health Professor of Biochemistry told Thailand Medical News, "This is an exciting new HIV therapeutic option for both prevention and treatment, with a unique mechanism of action compared to other approved drugs. It has great potential to help patients who suffer from drug resistance as well as those who would benefit from a longer-acting, injectable anti-HIV drug cocktail."
 
More than 41 million individuals are currently living with the infection and there were more than 1.8 million new infections in 2019.
 
To date, it has been reported that combination antiretroviral therapy (cART), the so-called "drug cocktail," has dramatically improved survival and quality of life for such patients, but it is also costly, often has serious side effects, and requires patients to take pills daily.
 
Furthermore, because HIV frequently mutates, drug resistance is a constant challenge, Dr Kay says, so researchers are always seeking new drugs with novel mechanisms of action to produce more robust combination therapies.
 
The researchers tested a unique drug called CPT31 in this new study, based on a D-peptide that targets a critical pocket on HIV's fusion machinery that rarely mutates.
 
D-peptides are mirror images of naturally occurring peptides. To imagine it, think of right and left hands. The building blocks and overall structure of natural peptides are analogous to our left hand versus our right hand for D-peptides.
 
As a result of that unique feature, CPT31 and other D-peptides are not degraded in the body. Therefore, they last much longer than natural peptides, making them especially suitable for a long-acting injectable formulation.
 
Dr Brett Welch, a co-author of the study and senior director of technology and strategy at Navigen, Inc., the Salt Lake City company that co-developed CPT31 and is managing clinical trials said, "In addition to their durability in the body, D-peptides are largely ignored by the immune system, preventing immune reactions that ar e a side effect often seen with traditional peptide and protein drugs. As a D-peptide, our hope is that CPT31 will provide extended viral suppression with a lower dose and reduced side effects."
 
In order to evaluate if CPT31 could prevent HIV infection, Dr Kay and colleagues first injected the drug into healthy macaque monkeys starting several days prior to exposure to a hybrid simian-human form of HIV called SHIV. The monkeys were completely protected from this very high SHIV exposure, much higher than what humans typically encounter, and never developed signs of infection.
 
Subsequently, the scientists identified the minimum dose of CPT31 needed to confer complete protection, information that will help inform clinical trials.
 
Dr Kay said, "We think this drug could be used by itself to prevent HIV infection because initial HIV exposure typically involves a relatively small amount of virus. This study showed that the vast majority of circulating HIV strains from around the world are potently blocked by CPT31."
 
The study team also wanted to address the issue about later stages of the disease when there are billions of copies of the virus circulating in the body, and they gave CPT31 to monkeys with untreated SHIV infections and high viral loads. Over the course of 30 days, the drug significantly lowered the presence of SHIV in their bloodstreams. However, virus levels rebound in two to three weeks due to drug resistance, as typically observed when treating established infections with a single drug.
 
The researchers also tested the drug's ability to maintain viral suppression after a cART drug cocktail is discontinued in macaques. cART reduces SHIV to an undetectable level, but the virus rapidly rebounds after discontinuing therapy (as also seen in humans). In this study, CPT31 by itself effectively kept the virus at an undetectable level for months (until drug administration was discontinued).
 
Dr Kay added, "Such a simplified 'maintenance therapy' could present patients with a new option for viral control that is more cost-effective, convenient to take, and has fewer side effects.”
 
Navigen is developing a long-acting injectable formulation of CPT31 with the goal of only requiring injection of the drug once every three months in parallel with ongoing clinical trials.
 
Dr Welch said, "Long-acting injectable formulations appear to be greatly preferred by both patients and physicians compared to current daily drug regimens that can be challenging to maintain. Additionally, the steady therapeutic drug levels provided by such a formulation would reduce the risk of drug resistance caused by missed daily pills, as well as reduce side effects."
 
There will be upcoming human trials, scheduled for late 2020, which will help determine whether CPT31 is safe and effective in humans.
 
Dr Kay warned that the full course of human clinical trials and subsequent FDA approval could take several years.
 
Another long lasting HIV drug that is that is under development is Lenacapavir which needs to be only taken once in every six months. The  drug is being developed by Gilead Pharmaceuticals. https://www.thailandmedical.news/news/breaking-news-hiv-study-shows-new-hiv-drug-lenacapavir-taken-once-every-six-months-can-maintain-low-viral-loads-effectively
 
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