2023-09-06 15:02:23
Authorized in Europe under the brand name Sunlenca®, lenacapavir is a capsid inhibitor antiretroviral agent, used mainly in cases of multiple resistance to available antiretrovirals. Its oral form can take over if necessary.
First drug of its kind to be approved for the treatment of HIV Human Immunodeficiency Virus. In English: HIV (Human Immunodeficiency Virus). Isolated in 1983 at the Pasteur Institute in Paris; recently discovered (2008) rewarded with the Nobel Prize in Medicine awarded to Luc Montagnier and Françoise Barré-Sinoussi. it offers an alternative in cases of resistance to several classes of existing antiretrovirals. The molecule is offered in the form of oral tablets or injections. Its long half-life in the body allows it to be administered by subcutaneous injection every six months. It also exists in an oral formulation which is used before the start of the injection treatment and which can be used as a temporary “bridge” if the injections have to be interrupted.
In December 2021, the US Food and Drug Administration suspended studies involving lenacapavir until May 2022 due to safety concerns about the glass vials used for the injectable formulation.
During this period, participants in the CAPELLA and CALIBRATE trials took lenacapavir tablets once a week. All CALIBRATE participants maintained viral suppression, as did most CAPELLA participants.
Among the 11 people with a viral load The plasma viral load is the number of viral particles contained in a sample of blood or other container (saliva, CSF, sperm, etc.). For HIV, viral load is used as a marker to monitor disease progression and measure the effectiveness of treatments. The level of viral load, but even more so the CD4 count, participate in the decision to treat with antiretrovirals. detectable at the time of switching to tablets, three achieved viral suppression while taking the pills, and none had a noticeable increase in viral load. One CAPELLA participant missed two doses of oral lenacapavir and experienced viral recovery (above 50 copies), but viral load was suppressed again after injections were resumed.
Bibliography
Ogbauga O et al. Lenacapavir oral bridging maintains efficacy with a similar safety profile when SC LEN cannot be administered. 12th International AIDS Society Conference on HIV Science (IAS 2023), Brisbane, Australia, abstract OAB0205, 2023.
Singh R et al. Pharmacokinetic bridging with oral Lenacapavir for missed subcutaneous Q6M dosing. 12th International AIDS Society Conference on HIV Science (IAS 2023), Brisbane, Australia, poster TUPEB07, 2023.
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