23 September 2019

An implant instead of a bunch of pills

The injectable multicomponent implant of prolonged action provides HIV prevention and treatment

"Scientific Russia"

A new study published in Nature Communications (Benhabbour et al., Ultra-long-acting tunable biodegradable and removable controlled release implants for drug delivery) demonstrates a promising alternative for those who must take pills daily to treat or prevent HIV, according to a press release from UNC Long-Acting Injectable Multi-Drug Implant Shows Promise for HIV Prevention and Treatment.

Researchers from several departments of the University of North Carolina at Chapel Hill, who are engaged in HIV treatment and prevention, have been conducting animal studies for seven years to create the best injectable drug implant that can combine several drugs and have an ultra-long-lasting effect, as well as solve many problems associated with modern methods of HIV treatment and prevention.

"There is no FDA–approved or marketed technology for long–term HIV prevention, and this is the first time we are using this delivery method with multiple antiretroviral drugs," says Rahima Benhabbour, first author of the study and associate professor in the Joint Department of Biomedical Engineering at UNC_NCSU. "Getting HIV prevention treatment consisting of an injection once or twice a year would have an incredible impact on patients." She added: "This technology is promising not only for HIV, but also for any type of disease that requires daily medication. We are talking about a safe, removable, long-lasting injection that relieves itself of the burden of following a daily medication regimen."

Antiretroviral drugs are used for both HIV prevention and treatment, and combine different types to counteract resistance to any one antiretroviral drug. These medications must be taken consistently every day. There are many obstacles to compliance with these drug regimens. Benhabbor says this is especially true for healthy people trying to prevent infection.

"In sub–Saharan Africa, where HIV prevalence is highest, access to these medications can be difficult, and there is a high stigma associated with the virus," Benhabbour said. "A person who does not have HIV needs not only to access medications, but also to connect with HIV, taking pills every day."

In addition, the human factor is triggered here. Anyone who tries to take multivitamins daily knows that sometimes they skip pills or take them at other times of the day. But such small deviations can make antiretroviral drugs less effective.

"Since one of the biggest difficulties associated with HIV prevention is the lack of adherence to medication, we wanted to create a drug delivery system that would essentially solve this problem," said senior author J. Victor Garcia, MD, Director of the International Center for the Development of Translational Sciences and a member of the UNC AIDS Research Center.

An injectable implant consists of three elements – an organic solvent, a polymer, and a drug or drugs that need to be delivered. The result is a honey-like liquid that, when injected under the skin, turns into a solid substance. This phase inversion occurs when the solvent diffuses into the body, leaving behind a polymer and a drug (or agents), the combination of which determines for what period of time the drug (drugs) will be released into the circulatory system.

In this study, six antiretroviral drugs were tested, and all of them retained their physical and chemical properties in the composition and after release. All six were also released from the implant at effective levels for an extended period of time from one month to a year.

The drug release implant, created by the UNC research group, for the first time eliminates several disadvantages of the existing method of delivering long-acting drugs for the treatment of HIV infection, namely, the ability to remove it and quickly eliminate the presence of a residual drug in the system.

"If a patient needs to refuse treatment because he had a bad reaction to the drug, or perhaps a woman became pregnant, our implant can be easily surgically removed," said Martina Kovarova, PhD, author of the article and associate professor of medicine at UNC SOM.

This is the first ever implantable implant for the treatment of HIV, which can be removed within a week or several months after the introduction, and within one week drugs are removed from the body. If the implant does not need to be removed, it decomposes into lactic and glycolic acids, which are already present in the body and are easily absorbed.

The researchers plan to continue developing and improving this multi-drug delivery system by observing its effects in appropriate in vivo models and eventually in humans.

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