AbbVie Expands Global Supply of HIV Drug Kaletra (Lopinavir/Ritonavir) for Experimental Use in COVID-19 Treatment
Mar 10, 2020 10:31
CST Updated
10:31
AbbVie
Innovative Drug Developer
March 10, 2020 /Bio ValleyBIOON/ -- AbbVie recently confirmed its activities in addressing the public health crisis of the novel coronavirus pneumonia (COVID-19), including supporting the experimental use of the HIV drug Kaletra/Aluvia (Chinese trade name:Kaletra，lopinavir/ritonavir，Lopinavir/Ritonavir), to determine its treatment for coronavirus disease 2019 (COVID-19）therapeutic efficacy.
AbbVie has provided Kaletra/Aluvia (lopinavir/ritonavir) as an experimental treatment option for COVID-19 to multiple countries facing urgent patient needs due to the pandemic. The company plans to continue responding to all appropriate product requests while supporting efforts to determine the safety and efficacy of this therapy in patients with COVID-19.
The company is collaborating with selected health authorities and agencies worldwide to determine the antiviral activity, efficacy, and safety of lopinavir/ritonavir against COVID-19. AbbVie is supporting clinical studies of lopinavir/ritonavir andBasic Research, and with European health authorities and the U.S. Food and Drug Administration (FDA), the U.S. Centers for Disease Control and Prevention (CDC), the U.S. National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA) to closely collaborate and coordinate these efforts. The company has also joined the Innovative Medicines Initiative (IMI) in Europe, working with industry partners to support the research and discovery of targeted therapies for COVID-19.
AbbVie Chairman and Chief Executive Officer Richard A. Gonzalez stated, “We are committed to helping address the COVID-19 public health crisis in any way we can, which is why we rapidly responded in late January to the request from Chinese authorities for Aluvia (lopinavir/ritonavir). We are collaborating with global health authorities to ensure that we meet the needs of patients with COVID-19 and conduct appropriateClinical Trialto evaluate its efficacy, while continuing to ensure an uninterrupted global supply of Kaletra/Aluvia (lopinavir/ritonavir) to people living with HIV.
According to the queryThe "Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia" issued by the National Health Commission (Click to Visit the Official Website）Trial Version, fromSecond Edition to Seventh Edition (Latest)in the antiviral treatment regimen,All regimens included Kaletra (lopinavir/ritonavir [200 mg/50 mg per capsule], 2 capsules per dose, twice daily).In the seventh edition (latest version) of the trial implementation, drugs included in antiviral therapy are:α-interferon, ribavirin, lopinavir/ritonavir, chloroquine phosphate, arbidol.
Kaletra/Aluvia is a fixed-dose combination formulation consisting of lopinavir and ritonavir. Lopinavir is an HIV protease inhibitor that blocks the cleavage of the Gag-Pol polyprotein, resulting in the production of immature, non-infectious viral particles. Ritonavir is an active peptidomimetic inhibitor of aspartyl proteases in HIV-1 and HIV-2. By inhibiting HIV protease, it prevents the enzyme from processing the Gag-Pol polyprotein precursor, leading to the formation of immature HIV particles that are unable to initiate new infection cycles. Ritonavir inhibits CYP3A-mediated metabolism of lopinavir, thereby achieving higher plasma concentrations of lopinavir.
No Expected Impact of the COVID-19 Pandemic on Drug Supply：AbbVie has made Kaletra/Aluvia (lopinavir/ritonavir) available as an investigational treatment option for COVID-19 to multiple countries facing urgent patient needs due to the coronavirus pandemic. The company plans to continue responding to all appropriate product requests while supporting efforts to determine the safety and efficacy of the drug in patients with COVID-19.
While helping to address the COVID-19 crisis is a high priority, the company remains committed to protecting the supply of Kaletra/Aluvia for patients with HIV/AIDS. AbbVie is actively assessing the increased demand for Kaletra/Aluvia (Kaletra) and has taken steps to increase supplies for patients with COVID-19 without affecting treatment supplies for patients with HIV.
AbbVie will continue to closely monitor manufacturing and supply chain resources worldwide, and does not anticipate any disruption to its drug supplies due to COVID-19. (Bioon.com)