Expectations are growing in the clinical field with the imminent reimbursement of the long-acting HIV (human immunodeficiency virus) treatment ‘Vocabria+Rekambys’ combination in Korea.

It has been more than two years since the combination was approved in Korea, but it has not yet been released on the market due to hurdles including costs. As patients have been waiting for its release, it is expected to quickly gain influence with reimbursement coverage.

According to industry sources, GSK Korea concluded drug price negotiations with the National Health Insurance Service for the combination therapy of the new HIV drugs Vocabria (cabotegravir) and Rekambys (rilpivirine). Rekambys Janssen Korea’s product and GSK was in charge of its reimbursement listing process in Korea.

Both drugs were originally developed as oral medications and then developed into injectable drugs. Long-acting injectable drugs cannot cure HIV infection, but they are therapeutic agents that target white blood cells to help lower and maintain the level of the AIDS virus.

In February 2022, it was approved by the Ministry of Food and Drug Safety as a combination therapy for the treatment of HIV-1 infection in adult patients who are virologically suppressed, have no history of virological failure, and have no known or suspected resistance to cabotegravir or rilpivirine.

Currently, the market is divided between the three-drug combination therapy, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide, B/F/TAF) and the two-drug combination therapy, Dovato (dolutegravir/lamivudine).

Although many prescriptions have been made before Biktarvy and Dovato, like Gemvoya and Triumeq are still being prescribed, the weight has shifted to using the later released treatments.

According to the pharmaceutical research institution IQVIA, Biktarvy’s sales in 2023 had been KRW 54.5 billion, the highest among HIV treatments. This is an 11% increase compared to the KRW 49.1 billion in sales in 2022.

Dovato also has a growth curve of KRW 13.2 billion in 2021, KRW 20.3 billion in 2022, and KRW 26 billion in 2023, after generating KRW 1.8 billion in sales at the time of its reimbursement approval in 2020.

The biggest strength of the Vocabria+Rekambys combination that has emerged in this situation is its convenience.

While existing HIV treatments are oral drugs that must be taken every day for 365 days a year, the combination therapy that includes Vocabria can reduce the frequency of administration to a maximum of six times a year with intramuscular injections administered once a month or once every two months.

This strength is regarded to be effective in alleviating the anxiety of social stigma, which is considered a challenge for people living with HIV.

According to a survey conducted by Love for One, an organization for people living with HIV, 73% of people living with HIV in Korea said they were afraid that taking HIV medication would reveal their infection to others and the surrounding environment.

As there are already inquiries from patients about the combination therapy Vocabria+Rekambys in the clinical setting, experts believe that there will be a lot of switching of treatments.

“The existing treatment requires taking one pill every day, so people have to take it in the middle of work or face stressful situations such as business trips or travel,” said Jin-nam Kim, a professor of infectious diseases at Hanyang University Hospital. ”Even before its release, there were patients who inquired about the treatment because they could avoid having to think about their daily lives if they could just get a shot at the hospital once a month.”

As the number of treatments that require periodic injections, such as rheumatism and atopic dermatitis, has increased, it is believed that this may reduce the burden of social stigma felt by patients.

However, the combination therapy of Vocabria+Rekambys is not all-encompassing, so the influence of existing treatments is expected to remain.

Conventional treatments are usually prescribed at a hospital visit every 3 months, and in some cases, every 6 months.

However, since the combination therapy is an injectable, the patient must follow the dosing cycle, and if it is difficult to shorten this cycle according to individual circumstances, it may be a burden to visit the hospital more frequently.

Professor Kim said, “Adherence to medication is important, and in the case of oral medications that are taken daily, if the patient has the existing medication, they can take it daily and maintain the drug concentration. However, although there is a seven-day margin before and after the administration date for injections, there are indeed limitations depending on the patient.”

The combination therapy of the two drugs is expected to be reimbursed by the National Health Insurance soon after it is approved by the Health Insurance Policy Deliberation Committee.

In response, Professor Kim said that he could not make a definite statement as no treatment has been released yet, but based on patient inquiries, he expected that at least 10% of patients would switch.

He added, “Injectable drugs cause pain at the injection site, and there are new drugs, so I don't think many will change at once. Still, the number of patients who inquired was in the double digits (more than 10%), and since the efficacy has already been proven through various studies, some patients will switch when provided with more options.”