A once-a-month PrEP pill may be on its way.
For a new drug to come to market, it must pass at least three different trials before being submitted to the FDA for approval for use in the U.S.
Islatravir, formerly known as MK-8591, is being developed by the pharma company, Merck. It has already reached its second stage of trials. Following promising results, it looks likely to go to Phase 3 trials, bringing it one step closer to approval.
Among those studying its effects is Sharon L. Hillier, Ph.D., professor of reproductive infectious disease at the University of Pittsburgh School of Medicine and director of reproductive infectious disease research at UPMC Magee-Women’s Hospital in Pittsburgh. According to Healio,
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Hillier told reporters during a virtual HIV prevention meeting that Islatravir was “extremely potent [with] an extremely long half-life.
“Which means that it’s a long-acting agent that can be used for prevention or treatment.”
Related: 5 ways to get PrEP delivered to your doorstep
In its phase 2 trial, 250 participants at low-risk of HIV were recruited to receive either six monthly doses of Islatravir or a placebo.
Those taking Islatravir were monitored to see how quickly the medicine entered their bodies and how long it remained potent.
The Islatravir participants were found to have levels of the drug, “well above the prespecified PK threshold for HIV-1”.
Further investigation revealed “rapid, sustained and adequate distribution” throughout all tissue samples (i.e. in the parts of the body where it’s needed).
Hillier said a Phase 3 trial will commence later this year, first on cisgender women in the US and Africa, and then on trans women and gay men globally.
Hillier said that because the drug has a long half-life (the amount of time it takes to decrease in potency by half), it would hopefully not matter too much if people were a little late taking their dose: they would probably still have protection for longer than just one month.
Although promising news, further success in Phase 3 trials will be critical for it to be approved by the FDA.
Last November, the FDA called a long-acting PrEP injection a “breakthrough therapy”. Cabotegravir has been designed to be administered by a health professional once every eight weeks. Designating a treatment as a ‘breakthrough’ means the FDA has been impressed by trial results and will work with a pharmaceutical company to speed up a therapy going through the approval process.
Related: FDA says injectable PrEP a ‘breakthrough’ therapy as it pends approval
Although many people are happy to take a daily PrEP pill, other people struggle, including those with mental health or substance abuse issues. Long-acting pills or injections, whether for convenience or necessity, may prove yet another tool in the ongoing battle to end the HIV epidemic.
Chrisk
We never got the vaccine but this is pretty darn close.
Harley
Why develop a vaccine “one and done”, develop a monthly pill you have to take forever. Much more profitable.
Den
Being specifically a disease of the immune system, vaccines become extraordinarily difficult to make for HIV. They keep trying, but it may never happen.
Drug companies make the most money from drugs for “lifestyle” diseases (High blood pressure, diabetes, obesity, heart disease, certain cancers and more), mental health issues (ADHD, PTSD, OCD, Depression, anxiety, etc.), autoimmune conditions (arthritis, lupus, psoriasis, MS, and so on), and other things not related to specific pathogens.
Openminded
Den, you are so right. I remember an interview with a pharma scientist who’s answer to why we didn’t have a cure for cancer. He replied, “because they pay us to find a treatment for cancer, they don’t pay us to find the cure”. You gotta love big pharma for saving so many lives, but at the same time you gotta hate them for only being in it for the money. I appreciate the quick and apparently safe turnout of COVID vaccines, but God only knows how much money it’s costing the taxpayers in greedy profits above the actual cost to develop.
fur_hunter
One reason major diseases, viruses and cancers will NEVER have cures is because the treatments and medications are too profitable for pharmaceutical and medical companies. They are not going to end the golden goose. GREED!!!!!!!
Den
In reality one of the main reasons that viruses and cancers “will NEVER have cures” is that it simply may not be possible to cure some of them. The notion that drug companies don’t make them because they would not be profitable is just another “conspiracy theory” with no basis in reality. And one that has lead to many “miracle cure” scams.
Cancer is a multitude of diseases with many causes, different behavior, and different responses to interventions. Cancer cells are also variably motile, so they move through the body and they mutate easily. Viruses are not even really living things, so they are essentially impossible to kill. There have been almost no “cures” for viral diseases other than maintaining body function until the immune system clears the virus out. There is no analogue for antibiotics, which actually kill them or damage their ability to reproduce allowing the immune system to get the upper hand very quickly. Viruses have no biological processes of their own, unlike bacteria. So any drug that prevents binding of the virus, also is likely to damage receptor sites on the cell. Any drug that prevents replication is likely to also hurt the host cell. So antivirals with few side effects are very hard to come by. Vaccines are the best weapon, and some viruses are hard to make vaccines for.
Cancer is similar that way, it is human cells. Very hard to find chemicals that kill cancer cells without killing or seriously damaging normal cells. Immunotherapy which helps the body’s immune system recognize cancer better and more quickly has made great strides, but this stuff is all very difficult.
Any drug company that came up with a cure for even the cold (which is actually caused by several different viruses) would make a fortune. If they could, they would.
CityguyUSA
You people are brainwashed over this pill that there’s no need to take. You don’t need a drug that could destroy your liver. A condom protects you from most nasties, not just HIV. What do you gain by taking their pill?
Chrisk
Yeah, condoms have been so damned effective. Who cares about all these new infections as long as you get to feel smug and superior. Dumbass.
Cam
Wow, if ONLY people had been saying “Use Condoms” during the 80s and 90s, there would be no HIV today.
Except they were saying that and it is still here.