Hope as FDA approves injectable drug for resistant HIV
The United States’ Food and Drug Administration (FDA) has approved twice-a-year injections and tablets for treating HIV in adults with multi-drug resistant infection.
The United States’ Food and Drug Administration (FDA) has approved twice-a-year injections and tablets for treating HIV in adults with multi-drug resistant infection.
The drug will cost $42,250 (5.1 million) for the two shots, with users then required to fork out $39,000 (4.7 million) a year for maintenance shots.
Currently, a similar drug called Cabenuva (cabotegravir and rilpivirine) from the United Kingdom’s GSK, which in 2021 became the first FDA-approved injectable for HIV, costs $40,000 to $50,000 (Sh4.9 million to Sh6.1 million) a year.
According to experts, Sunlenca (lenacapavir), which is used to treat people with multidrug-resistant HIV, will be a game changer.
“The approval ushers in a new class of antiretroviral drugs that may help patients with HIV who have run out of treatment options. The availability of new classes of antiretroviral medications may possibly help these patients live longer, healthier lives,” said Dr Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research.
Sunlenca is the first HIV-1 capsid inhibitor that the FDA has approved. It functions by obstructing the capsid protein coat of the HIV-1 virus, interfering with the viral life cycle. It received FDA designations for priority review, quick track and breakthrough therapy.
Permission was granted based on a trial involving 72 patients with HIV who had high viral loads and were resistant to several types of medicines.
During the trials, Sunlenca or a placebo was randomly given to patients in the first group, while open-label Sunlenca was given to the second group.
Compared to 16.7 per cent of individuals getting a placebo, 87.5 percent of patients receiving Sunlenca experienced a predetermined drop in virus load throughout the first 14 days.
After 26 weeks, 81 per cent of patients using Sunlenca with additional antiretroviral medications had HIV levels that were deemed undetectable. Some 83 per cent of participants still had HIV RNA suppression at 52 weeks.
Sunlenca is administered in conjunction with other antiretroviral medications, with oral tablets and subcutaneous injections serving as the initial dose, and maintenance injections administered every six months after. Nausea and injection site reactions were the most frequent side effects of the drug.
If a patient additionally takes medication that lowers Sunlenca levels, they shouldn’t receive Sunlenca. Loss of virologic response and the emergence of viral resistance may follow from this.
This was lenacapavir’s second go-with the FDA. The regulatory agency had refused to approve drug in March last year, citing issues related to the compatibility of vials and lenacapavir solution. In August the European Commission approved Sunlenca for treatment-resistant HIV.
“Lenacapavir helps to fill a critical unmet need for people with complex prior treatment histories and offers physicians a long-awaited twice-yearly option for these patients who are at greater risk of progressing to Aids,” said Jean-Michel Molina, a professor of infectious diseases.
