Long-acting injectable cabotegravir (CAB-LA) has the potential to fill the gaps for people at high risk for sexually transmitted HIV who have trouble taking oral preexposure prophylaxis (PrEP), but several factors stand in the way of a widespread roll-out, say authors of a new review article.
CAB-LA “represents the most important breakthrough in HIV prevention in recent years,” write Geoffroy Liegeon, MD, and Jade Ghosn, MD, PhD, with Université Paris Cité, in Paris, France, in this month’s HIV Medicine.
It has been found to be safe, and more effective in phase 3 trials than oral PrEP, and is well-accepted in men who have sex with men, and transgender and cisgender women.
Reductions in Stigma
Surveys show patients at high risk for HIV — especially those who see PrEP as burdensome — are highly interested in long-acting injectable drugs. Reduced stigma with the injections also appears to steer the choice toward a long-acting agent and may attract more people to HIV prevention programs.
The first two injections are given 4 weeks apart, followed by an injection every 8 weeks.
Models designed to increase uptake, adherence, and persistence when on and after discontinuing CAB-LA will be important for wider roll-out, as will better patient education and demonstrated efficacy and safety in populations not included in clinical trials, Liegeon and Ghosn note.
Still, they point out that its broader integration into clinical routine is held back by factors including breakthrough infections despite timely injections, complexity of follow-up, logistical considerations, and its cost-effectiveness compared with oral PrEP.
A Hefty Price Tag
“[T]he cost effectiveness compared with TDF-FTC [tenofovir/emtricitabine] generics may not support its use at the current price in many settings,” the authors write.
For low- and middle-income countries, the TDF/FTC price is about $55, according to the World Health Organization’s Global Price Reporting, while the current price of CAB-LA in the US is about $22,000, according to Ghosn.
He told Medscape Medical News that because the cost of generics can reach $400-$500 per year in the US, depending on the pharma companies, the price for CAB-LA is almost 60 times higher than TDF/FTC in the US.
The biggest hope for the price reduction, at least in lower-income countries, he said, is a new licensing agreement.
ViiV Healthcare signed a new voluntary licensing agreement with the Medicines Patent Pool in July to help access in low-income, lower-middle-income, and Sub-Saharan African countries, he explained.
The authors summarize: “[E]stablishing the effectiveness of CAB-LA does not guarantee its uptake into clinical routine.”
Because of the combined issues, the WHO recommended CAB-LA as an additional prevention choice for PrEP in its recent guidelines, pending further studies.
Barriers Frustrate Providers
Lauren Fontana, DO, assistant professor at the University of Minnesota Medical School, Minneapolis, and infectious disease physician at M Health Fairview, told Medscape Medical News that “as a healthcare provider, cost and insurance barriers can be frustrating, especially when CAB-LA is identified as the best option for a patient.”
Lack of nonphysician-led initiatives, such as nurse- or pharmacy-led services for CAB-LA, may limit availability to marginalized and at-risk populations, she said.
“If a clinic can acquire CAB-LA, clinic protocols need to be developed and considerations of missed visits and doses must be thought about when implementing a program,” Fontana said.
Clinics need resources to engage with patients to promote retention in the program with case management and pharmacy support, she added.
“Simplification processes need to be developed to make CAB-LA an option for more clinics and patients,” she continued. “We are still learning about the incidence of breakthrough HIV infections, patterns of HIV seroconversion, and how to optimize testing so that HIV infections are detected early.”
Liegeon, Ghosn, and Fontana report no relevant financial relationships.
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick