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GSK Korea said its long-acting injectable HIV-1 combination treatment, Vocabria (ingredient: cabotegravir 600mg) and Rekambys (ingredient: rilpivirine 900mg), began to be covered by Korea’s national health insurance system on Tuesday.
GSK Korea's long-acting HIV injection therapy, Vocabria, and Rekambys, becomes the first of its kind to gain health insurance coverage, offering a bi-monthly alternative to daily oral treatment. (Credit: GSK Korea)
GSK Korea's long-acting HIV injection therapy, Vocabria, and Rekambys, becomes the first of its kind to gain health insurance coverage, offering a bi-monthly alternative to daily oral treatment. (Credit: GSK Korea)
This marks a significant milestone for the Vocabria and Rekambys combination regimen, the first long-acting injectable treatment for HIV-1 in Korea, reducing the treatment frequency from daily oral medication to a bimonthly injection schedule.
The therapy received regulatory approval from the Ministry of Food and Drug Safety in February 2022 for virologically suppressed adults with no history of treatment failure and no known or suspected resistance to cabotegravir or rilpivirine. The reimbursement criteria align with these indications.
Unlike conventional oral regimens requiring daily adherence, patients on the Vocabria and Rekambys therapy receive the injections every two months following an initial lead-in phase of monthly dosing during the first two months, reducing the total number of treatments to only six times per year.
While oral antiretrovirals have demonstrated potent viral suppression and good tolerability, issues remain in adherence and quality of life.
A recent patient perception survey conducted by Love for One, a community-based HIV group, on 164 people with HIV revealed that 52 percent experienced psychological distress linked to daily medication due mainly to fear of unintended disclosure or constant reminders of their condition.
Furthermore, 46 percent reported missing doses within the last three months. Notably, 68 percent expressed a desire to switch to long-acting injectable treatments, citing reduced daily burden (85 percent) and minimized risk of exposure (75 percent).
The injectable regimen's efficacy and safety were confirmed in the global phase 3 SOLAR trial, a randomized, open-label, multicenter study directly comparing Vocabria and Rekambys with a standard triple oral therapy (BIC/FTC/TAF).
At 12 months, the rate of virologic failure (HIV-1 RNA ≥50 copies/mL) was 1 percent in the injection group and under 1 percent in the oral group, meeting the non-inferiority margin.
The share of participants achieving virologic suppression (HIV-1 RNA <50 copies/mL) was 90 percent in the injection group and 93 percent in the oral group. Aside from mild injection site reactions, safety profiles were comparable between both groups.
Even patients previously satisfied with their oral regimens reported higher treatment satisfaction after transitioning to long-acting injections. According to study findings, 90 percent (382 out of 425) of patients who received the injectable regimen preferred it over their previous oral medications.
Major reasons included freedom from daily pill-taking (85 percent), convenience (83 percent), and reduced anxiety over social stigma (61 percent).
“Daily oral regimens are highly effective, but the burden of daily dosing remains a significant issue, especially among younger patients in their 30s and 40s who are more likely to be socially active,” said Professor Chin Bum-sik of the Department of Internal Medicine at National Medical Center. “Events like business trips or vacations can easily disrupt their treatment routines.”
He added that long-acting injectables can significantly improve adherence, reduce the risk of viral transmission, and alleviate the psychological stress associated with daily medication.
“We are pleased that insurance coverage will now enhance access to this innovative long-acting treatment,” said Yang Yoo-jin, managing director of GSK Korea's HIV unit. “Following our launch of Dovato, the first FDA-approved two-drug oral therapy based on dolutegravir, we are proud to introduce Korea’s first long-acting HIV injection regimen.”
GSK remains committed to ensuring no person living with HIV is left behind through continuous innovation in treatment options, Yang added.
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Lee Han-soo corea022@docdocdoc.co.kr
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