Earlier this month, a downtown Buffalo clinic began administering a treatment for Human Immunodeficiency Virus that replaces a daily diet of pills with a monthly pair of injections. Cabenuva's path to approval by the Food and Drug Administration earlier this year passed through Buffalo.
Cabenuva combines Cabotegravir and Rilpivirine. The HIV treatment gained the approval of the FDA in January 2021. Evergreen Health, located in downtown Buffalo, announced May 4 it had begun using the treatment on a handful of patients.
“This medication is definitely not for everybody. The patient has to be already controlled in HIV with conventionally available oral medication,” said Dr. Alyssa Shon, a physician at Evergreen Health who conducted clinical trials of Cabenuva through the University at Buffalo’s Jacobs School of Medicine and Biomedical Sciences. “They have to be already suppressed, meaning that their viral load has to be less than 50 (viral copies per milliliter of blood) on currently available medications. And they cannot have any resistance to any of the components of this drug.”
Prior to the FDA’s approval, patients in the trial had started the medication to ensure they would not have an allergic reaction or any other adverse responses to the treatment. The medications, according to Dr. Shon, were tolerated very well.
Qualified patients must first take a pill-based lead-in for 28 days before transitioning to injections. Recipients get two per monthly visit, in the gluteal section. Those interested in switching to the shots may do so because of pill fatigue, Dr. Shon suggested, but also because some do feel a stigma of living with HIV.
“Some of my patients have told me they hide their pill bottles, in fear of people looking at their medication bottles and knowing they have HIV,” she said. “And also, this kind of eliminates that process because they wouldn't be having any pills at home. They will be coming into the doctor's office, places like Evergreen and get their monthly injections. And then, they wouldn't have any pills to take for HIV at home.”
Evergreen Health, according to its 2020 numbers, provides care to an estimated 1,600 people living with HIV/AIDS. New York State has not yet released its 2020 statistics, but as of 2019 an estimated 3,400 people lived their diagnosis.
Erie County's new HIV cases, year to year, have generally gone down since 2015, when 120 cases were identified. But 2019's 75 new cases were up from 46 in 2018. What concerns health officials now is an upward trend in sexually transmitted diseases during the COVID-19 pandemic. The concern, according to Erie County Health Commissioner Dr. Gale Burstein, is the possibility of more infections than what are recorded.
“I think the problem with with the pandemic is that less people sought preventive care. We saw a decrease in in chlamydia cases. And we think it's not because there was less chlamydia. We think that people weren't going out and getting tested,” Dr. Burstein said. “It will be interesting to see the number of new HIV infections that are diagnosed in 2020 because, you know, you can't have a positive test unless you get a test in the first place.”
Long gone are the days, as in the 1980s, when an HIV-positive diagnosis was looked upon as a death sentence. The virus is now treatable and many living with HIV, through consistent treatment, are able to enjoy long, healthy, productive lives. Pre-exposure and post-exposure prophylaxes are available and function to keep patients "virally suppressed," meaning the virus is undetectable. Such treatments may also prevent the virus from being transmitted to another person.
Erie County provides HIV testing and wraparound services, including guidance toward clinics where individuals may receive direct treatment. Evergreen Health provides preventive prophylaxes.
There remain hurdles to making Cabenuva a more widely used option. It may only be administered by a specialty pharmacy or clinic. The patient cannot take it home and self-inject. And that's just one of the holdups.
“Since the approval process in January, there was always some lag in in terms of getting patients on these drugs, because the insurance companies had to review whether they will put this medication into their formulary,” Dr. Shon said.