Lopinavir- Ritonavir Not Effective in Adults with Severe COVID-19

March 20, 2020 - Hospitalized adult patients with confirmed COVID-19, experienced no benefits in lopinavir- ritonavir treatment compared to standard care, according to a recent clinical trial, LOTUS China (Lopinavir Trial for Suppression of SARS-Cov-2 in China).

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The open-label, individually randomized, controlled clinical trial posted in The New England Journal of Medicine was conducted from January 2020 through February 3, 2020. Ninety-nine patients were assigned to receive lopinavir-ritonavir twice daily plus standard care, and 100 patients received standard care alone.

The 160 patients were assessed the respective treatments once daily for a total of 14 days using specific data on a seven-category ordinal scale. Three patients in the lopinavir-ritonavir group did not receive treatment because of early death and two others were refused treatment.

Although mortality at 28 days was similar in the lopinavir-ritonavir group and the standard care group, lopinavir patients saw one less day for clinical improvement at 15 days, compared with 16 days in the standard-care group.

Because of the modest improvement period, patients in the lopinavir-ritonavir group had a shorter stay in the intensive care unit (ICU) than those in the standard care group, at six and 11 days, respectively.

But almost half (48.4) patients in the lopinavir-ritonavir group and 49.5 in the standard-care group saw gastrointestinal adverse events such as nausea, vomiting, and diarrhea.  Additionally, 14 percent of patients in the lopinavir group were unable to complete the study course due to these challenges.

Serious adverse events were more common in the standard care group(32 patients) compared to the lopinavir- ritonavir group (19 patients).

The randomized trial uncovered that lopinavir-ritonavir was not associated with improvement or mortality in seriously ill COVID-19 patients different from that associated with standard care alone.

“In conclusion, we found that lopinavir–ritonavir treatment did not significantly accelerate clinical improvement, reduce mortality, or diminish throat viral RNA detectability in patients with serious Covid-19,” researchers highlighted. “These early data should inform future studies to assess this and other medication in the treatment of infection with SARS-CoV-2.”

The novel coronavirus, or COVID-19, is now a pandemic according to the World Health Organization. The symptoms of the disease range from a mild respiratory tract illness to severe pneumonia.

Due to the rapid spread of coronavirus, experts and researchers are actively looking for treatment options for the disease.

Last week, the Bill and Melinda Gates Foundation, Wellcome, and Mastercard announced that they recently launched the COVID-19 Therapeutic Accelerator to boost drug discovery and biologics to treat COVID-19 patients.

“Viruses like COVID-19 spread rapidly, but the development of vaccines and treatments to stop them moves slowly. We believe we can help by partnering with private and philanthropic enterprises to lower the financial risk and technical barriers for biotech and pharmaceutical companies developing antivirals for COVID-19,” Mark Suzman, chief executive officer of the Bill and Melinda Gates Foundation, said in the announcement.

Although antiviral drugs have not been effective against COVID-19 thus far, experts voiced that this may be due to products not having an immediate market that could halt research altogether.

The Accelerator will share research, coordinate, invest, and pool resources by drawing on expertise from the World Health Organization. This is expected to further COVID-19 research.

By lowering financial and technical risks for academia, biotech, and pharmaceutical companies, the initiative will ensure drug products are accessible for all patients. The Accelerator will also work with regulators to align criteria and develop manufacturing capacity.

“The virus is an unprecedented global threat, and one for which we must propel international partnership to develop treatments, rapid diagnostics, and vaccines,” said Jeremy Farrar director of Wellcome. “Science is moving at a phenomenal pace against COVID-19, but the get ahead of this epidemic we need greater investment to ensure research co-ordination.”

Experts agreed that bringing together resources and expertise will de-risk pathways for new drugs for COVID-19 and future epidemic threats. This will ensure access for those in vulnerable communities.