New treatments in the fight against AIDS were overshadowed by the COVID-19 pandemic but were dramatic.
Approval of Cabenuva is the biggest advance in HIV treatment since a daily pill was approved that prevented death from the virus. The daily pill may now be replaced with a once a month injection. And research continues toward the goal of lengthening the time between injections from one month to two — maybe even longer.
North Texas Infectious Disease Consultants in Dallas is just one of the locations which has been conducting trials for the once-a-month Cabenuva treatments. Bryan King, vice president of clinical research and business development at NTIDC, said, “Our research department has participated in all the Cabenuva trials over the past 10 years. We actually gave one of the first injections here in the U.S.”
Dr. Chris Bettacchi is NTIDC’s principle investigator for all of its Cabenuva studies, King said, adding that NTIDC is “currently working with multiple sponsors, looking at long-acting medications that include Caspid Inhibitors, Broadly Neutralizing Antibodies — bnAbs — and other new concept medications that are administered by injection or IV infusion up to every six weeks.”
When the COVID pandemic began, researchers hoped some of the medications developed to fight HIV would work against the similar COVID-19 virus. One drug, remdesivir, showed early promise.
But Moderna, makers of one of the two mRNA vaccines against COVID-19, began human trials over the summer on an mRNA vaccine to protect against HIV infection.
Unlike live or inactive vaccines, mRNA vaccines do not contain parts of a virus. Instead, this class of vaccine is designed to create proteins that trigger an immune response. This approach eliminates some potential drawbacks — live vaccines must be kept cool or they will spoil, which can hamper distribution — and enables manufacturers to mass produce vaccine doses. The mRNA vaccines also give a person’s body the ability to possibly recognize new variants of a virus.
In November, the FDA gave approval to Excision BioTherapeutics to begin human trials on a treatment and possible cure for HIV. The treatment is based on CRISPR technology and requires just one infusion.
CRISPR is a technology to edit genes. It finds a specific bit of DNA inside a cell and alters that bit of DNA.
The treatment Excision developed finds HIV in the body and cuts it in three places to deactivate the virus cells. Cutting it in just one place allows the remaining HIV cell to mutate around the cut.
The infusion cut the amount of HIV in mice, but two-thirds remained somewhat infected. The question is how much of the HIV needs to be deactivated for the treatment to be considered a cure and for someone with HIV to live a normal lifespan without taking daily medication.
Because of the COVID pandemic, many people lost their jobs and, with their jobs, their insurance. That included many people getting their HIV medications through their health insurance plans.
The cost of COVID-19 treatment was covered by federal legislation, but not the cost of drugs no longer covered because of loss of insurance.
ADAP, the AIDS Drug Assistance Program, has generally covered the cost of HIV medications for those with no other insurance. But the flood of new claims this year left Texas short. In Dallas, AIDS organizations filled in with grants coming mainly from drug companies until the federal government caught up with claims and more people went back to work reclaiming their insurance coverage.
In December, U.S. Rep. Adam Schiff, D-Calif., and Sen. Tina Smith, D-Minn., introduced legislation requiring insurers to cover current and future HIV prevention drugs, or PrEP, and any associated costs.
Widespread uptake of PrEP is considered by many experts to be essential for ending HIV, particularly in minority communities. New CDC data shows the rate of new HIV infections among Black and Latino gay and bisexual men has not budged over the past decade.
The PrEP Access and Coverage Act aims to change that by requiring insurers to cover costs associated with taking PrEP — including the drugs, doctor’s visits and testing. It also establishes a grant program to expand access for uninsured individuals and underserved communities.
— David Taffet