A new implanted device could revolutionize HIV treatment by eliminating adherence as a factor in reaching successful outcomes. The matchstick-size device is designed to be implanted under the skin, where it can automatically deliver carefully measured doses of antiretroviral ARV drugs.
"To our knowledge this is the first implant to be used for this purpose," Dr. Marc Baum, president and founder of California’s Oak Crest Institute of Science (where the device was developed) said in a press release.
Working much like a contraceptive implant, the device could dramatically increase treatment adherence by freeing patients from having to maintain a daily regimen of HIV medication. Research has shown that uninterrupted adherence to antiretroviral regimens is critical for maintaining viral load suppression. Patients with an undetectable viral load not only avoid further damage to their own immune system but are also unlikely to transfer HIV to their sexual partners.
Shown in clinical trials to be one of the most significant factors in determining successful outcomes, adherence is also widely viewed as one of the most critical elements in the fight against HIV.
But some HIV-positive patients still struggle with adherence, especially if they are prescribed numerous drugs — whether to enhance drug effectiveness, provide cheaper treatment options, fight multiple HIV strains, or prevent the virus from becoming drug resistant.
Now researchers at Oak Crest hope their subcutaneous device will eliminate adherence as a factor in HIV treatment. Their findings, published in Antimicrobial Agents and Chemotherapy, show the device successfully delivered a controlled, sustained release of antiretroviral drugs for up to 40 days in tests on animals.
“This novel device will revolutionize how we treat or prevent HIV/AIDS,” Baum said. “It delivers powerful HIV-stopping drugs and eliminates one of the key obstacles in HIV/AIDS prevention — adherence to proper dosing regimens."
Birth control implants, which have been used successfully in the U.S. since 1993, utilize a small, flexible tube that is inserted under the skin of the upper arm. After insertion, it releases hormones that prevent ovaries from releasing eggs.
The new HIV device would work in a similar manner.
“It is easily inserted and removed,” Baum explained. “And [it] provides sustained release of the potent prodrug tenofovir alafenamide, which is roughly 10 times more potent against HIV than tenofovir disoproxil fumarate, another tenofovir prodrug that has been shown to prevent sexually transmitted HIV when used as a pre-exposure prophylaxis [PrEP].”
Now the researchers are moving forward with plans for human trials.
“We are very pleased with the results of our preliminary studies and are working diligently to develop a subdermal implant for HIV prevention that will remain effective for a full 12 months,” Baum said.