Gilead's Sunlenca (lenacapavir), which has been attracting attention for treating human immunodeficiency virus (HIV) with twice-yearly injections, will likely be administered for the first time in Korea.
On Tuesday, the Ministry of Food and Drug Safety (MFDS) approved the therapeutic use of Sunlenca and GSK's Rukobia (fostemsavir), two multidrug-resistant HIV drugs applied for by Severance Hospital.
This is the first time two recently developed drugs have won approval for therapeutic use in Korea.
Sunlenca is the first long-acting HIV-1 capsid inhibitor, a subcutaneous injection administered every six months. It is used as a combination therapy with other antiretrovirals in treatment-experienced, multi-drug resistant (MDR) HIV-1 infected people.
At the time of its development, Sunlenca was known as a "dream drug" for patients because it could maintain therapeutic effects with twice-yearly dosing.
Currently, HIV treatment is maintained with daily oral dosing of antiretrovirals. However, long-acting formulations are being developed, and the dosing frequency evolves every two to six months.
Therefore, the advent of Sunlenca offers hope to people infected with the disease. They can be relieved of the pressure to take a daily dose and ease the burden of treatment.
However, Sunlenca is still being used as a combination therapy with other drugs in a small number of patients for whom there are no other options available.
Given that Sunlenca was approved by the same agency on the same day as Rukobia, the two will likely be used together.
Rukobia is also the first HIV-1 gp120 inhibitor to be approved for use in combination with other antiretroviral agents for treating treatment-experienced, multidrug-resistant HIV-1 infected people.
Rukobia is an extended-release tablet taken orally twice daily, and it is anticipated that these two agents will eventually be used as salvage therapy in patients unable to tolerate or tolerate the side effects of domestically available HIV medications.
This is because the combination has recently been shown to be a safe treatment in patients with end-stage renal disease, including dialysis patients. It is also being tested as a promising treatment option for patients who have developed complications from long-term HIV treatment, reducing the burden of medication and the potential for drug-drug interactions.
Interestingly, this combines Gilead and GSK products, two of the biggest names in HIV drug development.
That also explains why experts are interested in seeing if this combination can move beyond its use as a salvage therapy and into forward-looking studies for full approval.