FDA approves breakthrough injectable HIV medication

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A breakthrough injectable drug combination for HIV, approved by the Food and Drug Administration on Thursday, will free some people from a daily pill regimen and may keep more of them on treatment that controls the infection, experts said.

Cabenuva, the medication developed by a partnership of ViiV Healthcare and Janssen Pharmaceutical Companies, is given every four weeks by medical providers in the form of two injections. Four decades after the first case of HIV was identified, it is the latest and most convenient option for treating what has become a chronic, manageable — but still incurable — disease.

Advocates celebrated the innovation. They said it might promote better adherence to medication use, remove the daily reminder of living with HIV that is symbolized by pills and strengthen privacy for people who are not public about their HIV status.

Monica Gandhi, an HIV researcher at the University of California at San Francisco and medical director of San Francisco General Hospital’s HIV clinic, Ward 86, called the development “an incredible and exciting breakthrough, a day we’ve been waiting for.”

Jesse Milan Jr., president and CEO of the activist group AIDS United, who is HIV-positive, said in a statement that “a long-acting, injectable form of HIV medicine is truly a medical breakthrough that will make the lives of people living with HIV easier and better. That cannot be stated enough.”

Even better news may be coming: A study released last month showed that injecting the same medications every eight weeks was as effective as administering them every four. ViiV Healthcare spokeswoman Melinda Stubbee said the company plans to seek FDA approval of that formulation by the end of March.

About 1.2 million Americans are living with HIV. To start on the injectable medication, the presence of virus in a patient’s blood must be nearly zero. The Centers for Disease Control and Prevention estimated in 2018 that about 65 percent of people with HIV qualify.

Kimberly Smith, head of research and development for ViiV, which is part of the drug company GlaxoSmithKline, estimated that overall, the injectable therapy may be appropriate for about 15 percent of people who have HIV.

Steven Harris, a 41-year-old Pittsburgh man who has been receiving the injectable drugs for two years as part of a clinical trial, said: “What I discovered after I started . . . [is] that there’s actually a really large benefit that I hadn’t expected. Until I was really away from the pills, I didn’t really realize the psychic toll it was taking on me.”

Now, Harris said, he is more able to “live my daily, normal life and just forget about my HIV.”

The new approach does not come without obstacles. Chief among them is cost: The wholesale acquisition cost of the monthly medications is $3,960, and the price of a one-month initiation dose that comes in pill form is $5,940. Officials at Janssen and ViiV said they believe the drugs will be covered by private insurance, Medicare and Medicaid, as many other HIV drugs are.

But Milan said that is not yet clear. He said each state will decide whether to extend Medicaid coverage to the new drugs and insured patients will have to battle private insurance companies over the sizable price tag.

Medically, patients risk developing resistance to the drugs if they do not keep to the monthly schedule of injections, a different kind of adherence problem, said Rick Nettles, vice president of U.S. medical affairs, infectious diseases and vaccines for Janssen, which is part of the Johnson & Johnson drug company.

The drug combination approved by the FDA includes Janssen’s rilpivirine, sold as Edurant, and a new drug, ViiV’s cabotegravir. They are taken as separate injections every four weeks. The FDA also approved Vocabria, the tablet form of cabotegravir, which should be taken with oral rilpivirine for one month before starting on injectable Cabenuva to ensure the medications are well tolerated, the FDA said.

The drug combination could face competition in coming years from a product that would be administered even less often that Gilead pharmaceuticals is testing for both prevention and treatment of HIV.

Cabotegravir also is being studied as a drug that could prevent HIV, a medication regimen known as pre-exposure prophylaxis that is taken in pill form.

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