The first long-acting injectable treatments for HIV were recommended for marketing approval on October 16 by the European Medicines Agency (EMA).
A combination injection of two new antiretroviral (ARV) medicines, rilpivirine (Rekambys) and cabotegravir (Vocabria) was recommended by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Instead of daily pills, patients would receive intramuscular injections monthly or bimonthly.
The combination injection is meant as maintenance therapy for adults with undetectable HIV levels (viral load <50 copies/mL) with their current ARV treatment and for those in whom the virus has not developed resistance to nonnucleoside reverse transcriptase inhibitors and integrase strand transfer inhibitors, according to the EMA.
According to a press release, the most common side effects are injection site reactions, headache, fever, nausea, fatigue, abnormal lack of energy, myalgia, and dizziness.
The CHMP opinion will now be sent to the European Commission for decision on a European Union–wide marketing authorization. Once granted, price and reimbursement decisions will be made for each country.
The standard treatment for HIV is a combination of ARVs from at least two classes that must be taken daily to suppress viral replication, increase number of CD4 cells, and stop disease progression.
“For some HIV-infected people treated with a stable and effective daily combination of ARV medicines, the availability of a long-acting ARV that reduces the dosing frequency presents a significant improvement by increasing overall satisfaction with treatment and reducing the burden associated with daily pill taking,” the EMA noted.
The two drugs work together to block the ability of the virus to replicate, the EMA explained in the press release. The long-acting injectable regimen does not cure HIV but helps reduce the amount of the virus and keep it at a low level.
The CHMP opinion was based on three phase 3 randomized, open-label, multicenter clinical trials with HIV-infected, treatment-naive or successfully treated adults. The studies demonstrated the safety and efficacy of the combination injection regimen when administered every 4 or 8 weeks.
More efficacy and safety data will be collected through a prospective cohort study and a 5-year study to assess real-world use. Postmarketing safety reports will publicize the results.
The World Health Organization reports that 38 million people were living with HIV worldwide in 2019. During the past 30 years, more 2.3 million people with HIV have been reported in the WHO European Region.
The US Food and Drug Administration declined to approve the injectable combination in December.
According to ABC News, the FDA was concerned about the manufacturing process, not the efficacy or safety of the combination.
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune 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.
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