Candidate: Kaletra® (also marketed as Aluvia; lopinavir/ritonavir)

Category: ANTIVIRAL

Type: HIV-1 protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children 14 days old and older.

Status: University of Oxford researchers conducting the the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial on June 30 released preliminary results showing that Kaletra yielded no significant mortality benefit in hospitalized COVID-19 patients. “Lopinavir-ritonavir is not an effective treatment,” declared Oxford Prof. Peter Horby, MD, PhD, the chief investigator for the trial, which enrolled over 11,800 patients from 176 NHS hospitals in the U.K.

Of those patients, 1,596 patients were randomized to lopinavir-ritonavir and compared with 3,376 patients randomized to usual care alone. Of these patients, 4% required invasive mechanical ventilation when they entered the trial, 70% required oxygen alone, and 26% did not require any respiratory intervention. There was no significant difference in the primary endpoint of 28-day mortality (22.1% lopinavir-ritonavir vs. 21.3% usual care), RECOVERY trial investigators said.

Kaletra in combination with injectable interferon beta-1b (marketed as Betaseron by Bayer and as Extavia by Novartis) showed a significant decrease in median time to a negative test for SARS-CoV-2 via nasopharyngeal swab compared with Kaletra alone—seven days vs. 12 days, according to results from a Phase II study in Hong Kong that was published May 8 in The Lancet.

AbbVie on March 31 announced a $35 million donation to support COVID-19 relief efforts by healthcare systems and other groups.

A 44-patient trial (NCT04252885) delivered disappointing results, concluding that both Kaletra and Arbidol (umifenovir) “seems little benefit for improving the clinical outcome of mild/moderate COVID-19,” and that Kaletra might lead to more adverse events than Arbidol, researchers reported in a preprint posted March 23 on medRxiv—but cautioned that further verification was needed because of the small sample size.

Kaletra fared worse in a 199-patient Chinese study (ChiCTR2000029308) that was published March 18 in The New England Journal of Medicine: “In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir–ritonavir treatment beyond standard care.”

In March, AbbVie waived patent rights to Kaletra after Israel issued a compulsory license for Kaletra as a treatment against SARS-CoV-2—while Mylan gave up its 180-day U.S. exclusivity for its generic version, allowing other drugmakers to make the antiviral should the HIV treatment prove effective against the SARS-CoV-2. AbbVie confirmed it was collaborating with health agencies and institutions globally to determine antiviral activity as well as efficacy and safety of Kaletra against COVID-19. The agencies include European health authorities, the FDA, the Centers for Disease Control and Prevention, the NIH, and the Biomedical Advanced Research and Development Authority (BARDA).

China’s National Health Commission in January authorized Kaletra to treat pneumonia caused by SARS-CoV-2. AbbVie donated RMB 10 million ($1.4 million) of Kaletra to Chinese authorities “as an experimental option to support this growing public health crisis.” And the Health Commission of Henan Province announced that three confirmed cases of patients diagnosed with new coronavirus infections recovered after taking Kaletra, a combination of ritonavir and lopinavir. Nucleic acid testing of more than 20 confirmed cases of patients infected with new coronavirus, admitted to hospitals in Zhejiang Province turned negative after taking Kaletra, according to Ascletis Pharma, which is evaluating a combination therapy of its own candidates ASC09 and ritonavir (See below).


COVID-19: 200 Candidates and Counting

To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:

● ANTIVIRAL
● VAX
● ANTIBODY
● RNA

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