AbbVie’s HIV therapy Kaletra fails to show efficacy in COVID-19

AbbVie’s HIV combination treatment Kaletra has failed to improve the condition of patients hospitalised with COVID-19, a British study has found.

The results, from the UK-based RECOVERY trial, were published in The Lancet yesterday, and the data definitively concludes that Kaletra (lopinavir-ritonavir) is not an effective treatment for patients admitted to hospital with COVID-19.

In the RECOVERY trial, 1,616 patients were randomised to receive Kaletra, compared to 3,424 patients who received standard-of-care.

Findings from the trial indicate the use of Kaletra in hospitalised COVID-19 patients does not reduce deaths within 28 days of starting the treatment – 23% of patients who received Kaletra and 22% of patients receiving standard-of-care died within 28 days.

In addition, researchers found that Kaletra did not curb the length of patients’ hospital stays, with 69% in the treatment group leaving with hospital with 28 days compared to 70% of those receiving standard-of-care.

There was also no significant difference observed in the risk of needing to be placed on a ventilator, with 10% of those in the Kaletra group requiring ventilation compared with 9% of those receiving standard-of-care.

The conclusive results confirm top line data from earlier studies of Kaletra in COVID-19, with the combination treatment failing to show benefit in a smaller study population. In June, the World Health Organization halted the evaluation of Kaletra treatment in its SOLIDARITY trial of hospitalised COVID-19 patients.

“The result from the RECOVERY trial is clear. When combined with findings from an earlier, smaller trial and with the WHO interim results, this provides strong evidence that lopinavir-ritonavir is not an effective treatment for patients hospitalised with COVID-19,” said Peter Horby, co-chief investigator of the RECOVERY trial.

“While it is disappointing that there was no significant benefit from lopinavir-ritonavir for patients in hospital, these findings have allowed us to focus our efforts on other promising treatments, and have informed the way in which individual patients are treated,” he added.

Although AbbVie has failed to repurpose its existing HIV drug for COVID-19, in June it partnered with biotech Harbour BioMed to develop a new antibody for the prevention and treatment of the novel coronavirus.

This includes the development and potential commercialisation of 47D11, a fully human neutralising antibody which targets a conserved region of the SARS-CoV-2 spike protein.