South Korea’s health insurance system began covering long-acting injectable HIV treatment, comprised of cabotegravir and rilpivirine, in April 2024, offering a novel option for managing the virus beyond daily oral medication. The treatment, marketed as Vocabria and Rekambys by GSK and Janssen respectively, is administered as an intramuscular injection every two months after an initial period of monthly injections.
The injectable therapy is indicated for HIV-1 infected adults who are virally suppressed and have no history of treatment failure, and no known or suspected resistance to either cabotegravir or rilpivirine. So patients must first achieve viral suppression through standard oral antiretroviral therapy before transitioning to the injectable regimen, according to the Ministry of Food and Drug Safety’s initial approval in February 2022.
The introduction of long-acting injectables addresses a significant challenge for HIV patients: adherence to daily medication. “Domestic HIV-infected individuals often feel a great deal of psychological burden while taking medication every day,” said Choi Jae-pil, a professor of infectious diseases at Seoul Medical Center, speaking at a launch event for the treatment. “Long-acting HIV injection therapy can be a treatment option that reduces exposure anxiety and provides high treatment adherence and satisfaction for domestic HIV-infected individuals.”
The treatment regimen involves injections of 2-3mL into both gluteal muscles, a larger volume than typical vaccinations, which has resulted in a high incidence of injection site reactions. A Phase 3 clinical trial, ATLAS-2M, reported injection site reactions in 76% of participants.
The cost of the injectable therapy is comparable to that of a three-drug combination pill, such as Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide), when covered by national health insurance. The injection schedule is initially monthly for two months, followed by maintenance injections every two months. Even slight deviations from the scheduled injection interval – up to seven days before or after – are permissible, offering flexibility for patients.
GSK is currently conducting clinical trials to evaluate the possibility of extending the injection interval to once yearly, potentially further reducing the burden on patients. The availability of this long-acting injectable represents a shift in HIV treatment strategies within South Korea, moving away from exclusively relying on daily oral antiretroviral medications.
