Sunlenca, an injectable therapy
The Food and Drug Administration has given the green light to Sunlenca, an injectable treatment for HIV that can help people who have become resistant to other treatments.
Experts say that the new injectable, which appears to work with less frequent dosing, could be a game-changer for people whose infections don’t respond to other treatments.
The drug, which was made by Gilead Sciences, is the first of a new class called “capsid inhibitors.” These drugs work by blocking the virus’s protein shell, or “capsid,” which interrupts several stages of the virus’s life cycle. In a clinical trial, after about a year, 83% of people who took Sunlenca with a combination of other drugs no longer had detectable levels of the virus.
Here are the facts.
What does Sunlenca do to treat HIV?
Sunlenca, also called lenacapavir, is the first drug in a new class of HIV medicines that has been approved by the FDA. Lenacapavir is an antiretroviral drug. It stops the virus from making copies of itself, which keeps the amount of HIV in the body very low.
Sunlenca is approved for HIV patients whose infections haven’t gotten better with more than one treatment plan. The treatment starts with a schedule of pills to take by mouth and injections. After that, injections are given every six months as maintenance.
Sunlenca is recommended for who?
Sunlenca was approved by the FDA for adults with HIV who haven’t been helped by other treatments, like those whose infections have become resistant to other drugs. There is some ambiguity over the exact number of Americans who are affected by HIV that is resistant to drugs, but the federal Centers for Disease Control and Prevention say that about 44% of HIV patients haven’t reached viral suppression.
Dr. Sabrina Assoumou, a doctor and infectious disease specialist at Boston Medical Center, said that the treatment could be enormously beneficial for older patients who had been diagnosed at the height of the epidemic and had trouble following earlier, more complicated treatment plans. This can lead to treatment resistance.
Emory University professor and infectious disease expert Dr. Wendy Armstrong said that the twice-yearly drug can also help people who have trouble getting care because they don’t have a way to get there, like not having a car. This is because it makes it easier to stick to the regimen. Other problems are being judged at home, living far from a clinic, or being homeless.
She said that the new therapy gives stakeholders a chance to “bring care that can work to people who have real problems with our current medication system.”
What do HIV experts worry about?
Starting treatment with the drug would cost $42,250, and maintenance shots would cost $39,000 a year.
Under the Ryan White CARE Act, many patients get their medicines through Medicaid and federal drug assistance programs. However, experts like Dr. William Short, chair of the board of directors at the American Academy of HIV Medicine, are still worried.
The medical community hopes that the drug will be added quickly to the formularies of insurance plans. With no fuss or bothersome barriers, “we expect that funders will make this product readily available to individuals who need it,” he said.
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Why is Sunlenca important?
Last year, the FDA has approved Cabenuva by ViiV Healthcare. It was the first intramuscular injection that could be given once every month to two months for the longest amount of time. Sunlenca is given just under the skin, which is called subcutaneously.
Assoumou said, “A subcutaneous injectable is unquestionably a game changer in terms of quality of life.” He went on to say that one day, people could give themselves these kinds of shots at home.
Experts say that research is being done to see if capsid inhibitors can be used for people who are starting a treatment plan for the first time or for prevention. Even though there is no cure for HIV, treatment options have made significant progress. Assoumou said that experts hope that more people will be able to get long-acting drugs, which could make treatment easier.
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