The U.S. Food and Drug Administration has approved Sunlenca (lenacapavir), a new antiretroviral drug for HIV-1-infected adult patients whose HIV infection cannot be successfully treated with other methods. Other existing treatments due to resistance, intolerance, or safety considerations.
Sunlenca is the first capsid inhibitor approved by the FDA to treat HIV-1. It works by blocking the HIV-1 protein coat (capsid)—interfering with the virus’ life cycle. It has been granted an FDA priority rating, fast trackand indicated breakthrough therapy.
The approval was based on a study of 72 HIV-infected patients who were resistant to multiple HIV medications and had high levels of the virus. Patients in the first group were randomly assigned to receive either Sunlenca or a placebo, while the other group received open-label Sunlenca.
Among patients receiving Sunlenca, 87.5% achieved pre-specified viral reduction in the first 14 days compared with 16.7% of patients receiving placebo. HIV levels were low enough to be considered undetectable after 26 weeks among 81 percent of participants receiving Sunlenca plus other antiviral drugs. At 52 weeks, 83% of participants continued to have HIV RNA suppression.
The starting dose of Sunlenca is treatment with oral tablets and subcutaneous injection, followed by maintenance injections every six months, and this drug is given in combination with other antiviral drug(s). The most common adverse reactions with Sunlenca were injection site reactions and nausea.
Sunlenca approval was granted to Gilead Science.
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quote: FDA approval of Sunlenca for treatment-resistant HIV (2022, December 29) retrieved December 29, 2022 from https://medicalxpress.com/news/2022-12-fda-sunlenca-Treatment-Resistance- hiv.html
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