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The Food and Drug Administration has approved Sunlenca, an injectable therapy to suppress HIV for patients who are resistant to other treatment regimens.
The new injection, which works in less frequent doses, could be a game changer for people with infections that have not responded to other treatments, experts say.
Developed by Gilead Sciences, the drug is the first of a new class of so-called capsid inhibitors, which work by blocking the protein coat or capsid of the virus, disrupting multiple stages in the life cycle of the virus. virus. In a clinical trial, 83% of patients taking Sunlenca with a combination of other drugs achieved an undetectable viral load after about a year.
What is Sunlenca HIV treatment?
- Sunlenca, or lenacapavir, is the first in a new class of drugs approved by the FDA to treat HIV.
- Lenacapavir is an antiretroviral medicine that works by stopping the virus from replicating to keep HIV levels in the body very low.
- Sunlenca is approved for HIV-infected patients whose infections have not responded to many other treatment regimens.
- Treatment begins with an oral and injectable regimen, followed by maintenance injections every six months.
Who is recommended to use Sunlenca?
The FDA has approved Sunlenca for adults with HIV who have not responded to treatments to control the virus, such as patients whose infections have become resistant to other drugs. It is unclear how many people have drug-resistant HIV in the United States, but the federal Centers for Disease Control and Prevention reports that about 44% of people receiving HIV treatment do not achieve viral suppression.
Treatment may be especially helpful for elderly patient For those diagnosed at the height of the epidemic and struggling to adhere to more complex treatment protocols, said Dr. Sabrina Assoumou, physician and infectious disease specialist at Boston Medical Center. earlier, may contribute to drug resistance.
Professor Dr Wendy Armstrong, an Emory University physician and infectious disease specialist, said the twice-yearly drug could also help patients who face barriers to care, such as lack of care. transportation, by making it easier to adhere to treatment regimens. Other barriers include facing stigma at home, living away from the clinic, or homelessness.
The new therapy, she said, provides an opportunity for stakeholders “to deliver care that can be effective to people who have real challenges with our traditional medicine system.”
What are the concerns of HIV specialists?
The drug will cost $42,250 to start treatment and then $39,000 a year for maintenance shots.
Many patients receive medication through Medicaid and federal drug assistance programs under the Ryan White CARE Act, but experts like Dr. William Short, chair of the board at the American Academy of HIV Medicine, remain fear.
The medical community hopes the drug will soon be added to the list of insurance plans.
“Our hope is that the payers will make this agent available to those who need it without significant obstacles or challenges,” he said.
Why is this new drug important?
Last year, the FDA approved ViiV Healthcare’s Cabenuva, the first long-acting intramuscular injection given every month to two months. Sunlenca is injected under the skin, or just under the skin.
“Subcutaneous injections are definitely a game changer in terms of quality of life,” says Assoumou, explaining that eventually, injections like these could be given at home.
Meanwhile, research is underway to test whether capsid inhibitors can be used for other patients starting a regimen for the first time or as a precaution, the experts said. HIV has no cure, but treatments have come a long way, and experts hope expanded access to long-acting drugs could pave the way for easier treatment. easier treatment regimenAssoumou said.
“This is a really exciting time for those in the field, in terms of improving quality of life and also having more options in our toolbox,” she said.
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