Why an RTP company’s new drug could be a game-changer for HIV prevention
ViiV Healthcare, a Durham-based biotechnology company, recently won the first regulatory approval for an injectable HIV preventative — providing a potentially game-changing alternative to the daily prevention pills that many take.
Prior to the approval on Dec. 20, the only HIV PrEP (pre-exposure prophylaxis) medications available to at-risk individuals came in the form of oral pills, such as the drug Truvada.
But ViiV’s new treatment, Apretude, would only need to be taken as an injection every two months.
Dr. David Wohl, an infectious disease specialist at UNC Health, said the arrival of the drug is welcome because many people struggle with keeping a daily regimen of pills.
“Right now all we have is a pill you would pretty much take every day,” he said in a phone interview. “A lot of folks don’t want to do that every day. Their risk isn’t every day, and it is a commitment.”
Wohl said giving people more options, like women have with contraception, could benefit many.
Just 25% of the 1.2 million people for whom PrEP is recommended have been prescribed it, according to the FDA. Though, that is a marked increase from 3% in 2015.
In U.S. Food and Drug Administration trials, the injectable was more likely to reduce HIV than daily oral medication. That was mainly due to the comparable ease of receiving an injection every two months, according to the FDA.
The FDA conducted two trials comparing Apretude to daily pills: one in men and transgender women who have sex with men and another in cisgender women.
In that first group, the injection provided 69% less risk of contracting infection than taking daily Truvada, according to the FDA. In cisgender women, it was found to have 90% less risk of infection than Truvada.
“We expect this to have a big impact,” said Dr. Kimberly Smith, head of research and development at ViiV, in an interview. “But it will take a while. It will not be overnight.”
ViiV Healthcare, founded in 2009, has a large presence in Durham. The company, created out of a joint HIV-focused venture by GlaxoSmithKline and Pfizer, has around 250 employees here, a figure that could grow, thanks to the approval. ViiV’s U.S. headquarters is based out of the American Tobacco Campus in downtown Durham.
The company has also made several injectable treatments for those who have already contracted HIV, including one called Cabenuva that can be taken as an injection every two months.
Spreading PrEP awareness
Apretude comes as the number of HIV infections are spiking across North Carolina. New infections had fallen slightly in 2020, though many experts believe that is due to a decline in testing during the pandemic.
Last year, there were 1,392 newly diagnosed HIV infections in North Carolina, a 29.1% increase in cases from 2020, according to data from the N.C. Department of Health and Human Services.
Those numbers could continue to grow in the coming years, Wohl said. A lack of testing during the pandemic could lead to more transmissions of HIV. And intravenous drug use rose during the pandemic.
Smith said that ViiV is planning a significant marketing rollout for Apretude, including television commercials and education initiatives.
“Because this is a new modality to administer PrEP, there is quite a bit of effort going into reaching difficult-to-reach populations,” she said. “Those would be cisgender women and Black or African American (men who have sex with men) and this Hispanic population. Those are the populations most at-risk at acquiring HIV.”
Smith said Apretude could also play a vital role in preventing HIV infections outside of the U.S. So far, the drug has only been approved in the U.S.
“The burden of HIV in the world is disproportionately outside the U.S. in Sub-Saharan Africa,” she said. “Five thousand young women become infected every week there.”
In general, Wohl said, the U.S. needs to invest more into educational campaigns around PrEP, especially in the South.
Wohl noted he recently had a patient who remarked that there are billboards for PrEP medications all over New Jersey but not in North Carolina.
“And more people live with HIV in the South than any other region in the country, with less PrEP,” he said.
A need for accessibility
However, all of ViiV’s marketing campaigns will be for naught, if it isn’t easy to access Apretude, Wohl said.
If someone can’t reliably access the injection at a local health department or doctor’s office, then they won’t get it, Wohl said.
“If health departments can’t give PrEP, it is almost a nonstarter,” he said. “We need it to be where people feel comfortable getting it, without the clinician jumping through hoops.”
There is also the issue of the cost.
The new injectable starts at a price of $3,700, according to Melinda Stubbee, a spokeswoman for ViiV.
She said the price is comparable to the monthly price of a branded oral daily PrEP. A generic of Truvada is available for a cheaper price, though.
She added the injection’s price does not include potential discounts or rebates from providers and insurers.
Wohl said he is concerned the price could steer away the most vulnerable populations.
“It does us no good if (Apretude) stays on the shelf because of bureaucracy or cost,” he said.
Stubbee said ViiV has multiple programs to provide assistance to those who may not be able to afford the medication. The company has a co-pay card program for those with insurance and a program that provides some uninsured people with free access to the drug.
“ViiV Healthcare is committed to providing assistance to eligible people living in the U.S. who need our medicines,” she said in an email.
Wohl said government could play a bigger role in making PrEP available.
“Government, when it wants to, can buy medicine and treat a pandemic,” Wohl said. “HIV is the original pandemic of our lifetimes before COVID hit. This is a way we can extinguish HIV. We were really close, getting 50,000 cases (of annual new infections) down to about 30,000 cases. The way to do it is get prevention out there.”
This story was produced with financial support from a coalition of partners led by Innovate Raleigh as part of an independent journalism fellowship program. The N&O maintains full editorial control of the work. Learn more; go to bit.ly/newsinnovate.
This story was originally published February 25, 2022 at 5:55 AM.
