HIV Drug in Severe COVID-19 Patients
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An open-label trial found no benefit for lopinavir-ritonavir (Kaletra), a protease inhibitor used primarily in HIV treatment, in treating hospitalized patients with COVID-19 coronavirus infection, according to researchers, New England Journal of Medicine.

In the current study, researchers examined data from hospitalized adult patients with confirmed COVID-19 infection and an oxygen saturation of 94% or less. Patients were randomized to receive either lopinavir-ritonavir twice a day for 14 days in addition to standard care or standard care (defined as supplemental oxygen, non-invasive and invasive ventilation, antibiotic agents, vasopressor support, renal-replacement therapy, and extracorporeal membrane oxygenation, as needed).

Overall, 199 patients were randomized -- 99 to the lopinavir-ritonavir group and 100 to a standard of care. The median age was 58, and about 60% were men. Median interval time between symptom onset and randomization was 13 days. Systemic glucocorticoids were administered to 33% of patients in the intervention group and 35.7% of patients in the control group. A modified intention-to-treat analysis found lopinavir-ritonavir associated with a median time of clinical improvement shorter by 1 day (HR 1.39, 95% CI 1.00-1.91). Interestingly, the intervention group also had a shorter stay in the intensive care unit versus standard care (median 6 vs 11 days, respectively), and duration from randomization to hospital discharge was also shorter.

Secondary endpoints "provide both reason for hope and reason for discouragement," they added, pointing to the somewhat lower number of deaths with lopinavir-ritonavir but no discernible effect on viral shedding. "Since the drug is supposed to act as a direct inhibitor of viral replication, the inability to suppress the viral load and the persistent detection of viral nucleic acid strongly suggest that it did not have the activity desired," they wrote.

The negative results might have been due to the selection of a "particularly challenging" population late in the course of infection with already considerable tissue damage. "Even highly active antibacterial agents have limited efficacy in advanced bacterial pneumonia," Baden and Rubin pointed out.

They concluded that while they found no benefit to lopinavir-ritonavir to treat COVID-19 infection, the effect of combining the drug with other antiviral agents, similar to what was done in SARS and MERS, "remains to be determined."

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