COVID-19 treatment update Here is an overview by a US physician who resides in Rome on the current state of play as it concerns various treatments of COVID-19. Cheers, BP
Molnupiravir: Merck has announced some very preliminary results for their new oral antiviral: COVID-19 outpatients who took it cleared virus from their noses faster than patients given placebo. This drug isn’t likely to hit your local CVS any time soon.
Natural immunity: Reinfection may be somewhat more common than we had thought. A study from Austria found a bout of illness to give more than 90% protection from reinfection, similar to what’s afforded by the best vaccines, for at least 7 months. But one from Denmark was less encouraging, reporting only about 80% immunity at 3-10 months in people under 65, and less than 50% in the elderly. The discrepancy is likely due to the routine testing done in Denmark; many of the cases picked up by their screening program were asymptomatic, so perhaps shouldn’t count.
Colchicine: The first oral medication thought to help COVID-19 outpatients has now done well in another trial, from Canada. In patients sick enough to be hospitalized, though, its value is uncertain. One small study in Brazil found highish doses to cut the duration of hospitalization by 25% and the number of days on oxygen by 40%. But in the much larger UK RECOVERY trial colchicine struck out, at least for its main endpoint of 28-day mortality.
Tocilizumab: Yet more mixed results, with 2 papers about critically ill COVID-19 patients in a single issue of the New England Journal of Medicine, one positive, one negative. They did have one crucial difference: in the positive trial, most patients were also being given steroids. Based on these results, the National Institutes of Health COVID-19 Treatment Guidelines Panel is now suggesting the drug be given together with steroids in very sick patients with high inflammatory markers in their blood, saying it “offers a modest mortality benefit.”
Baricitimib: A study of this “Janus kinase inhibitor” in hospitalized patients has now been published, and it looks pretty good: when the drug was added to remdesivir mortality fell from 7.8% to 5.1%.
This headline, “In Ancona robots help Covid patients with monoclonal therapy,” got visions of humanoids dancing in my head, rolling from bed to bed to stick needles into veins. Alas! The “robots” turn out to be just machines that help measure out doses.
Azithromycin: After failing to help hospitalized patients, this antibiotic has now proved equally useless in getting outpatients well faster or keeping them from getting worse.
Bamlanivimab: The good news is that Lilly’s monoclonal antibody is now available in Italy. The country has bought and paid for 150,000 doses, about equal to its number of new cases every week. The bad news is that the sacs are arriving in dribs and drabs, such that as of March 30th only 230 patients had been treated. More bad news: bamlanivimab has been withdrawn in the USA as a stand-alone therapy, because of poor efficacy against variants, though it can still be used in combination with another antibody, etesevimab. But there’s good news in the bad news: Bamlanivimab may be ineffective against the South African variant, but it seems to still be valid treatment for the B.1.1.7 English variant and the original Wuhan strain, the ones currently dominant in Italy. Whew.
VIR-7831: This new monoclonal antibody from GlaxoSmithKline performed brilliantly in a Phase 3 trial, reducing hospitalizations and deaths in high-risk outpatients by 85%. Judging from laboratory studies, it ought to work not only against the wild-type Wuhan strain and the B.1.1.7 variant, but against the South African and Brazilian variants as well. This could be a huge step forward, and the company has already applied for emergency use authorization in both the United States and the European Union.
Monoclonals Italian style: Toscana Life Sciences has begun Phase 1 human studies of a home-grown product. It has one huge advantage, being given as a single shot in the doctor’s office instead of an intravenous infusion in a hospital. But there’s many a slip ‘twixt Phase 1 and pharmacy shelves.
Protocols, redux: A month ago a court in Italy ruled in favor of some physicians who wanted to treat COVID-19 outpatients with a package of azithromycin, heparin, and corticosteroids (a gentler Indian version is illustrated at the top). One enthusiast told me on Facebook: “Hospitalizations will drop dramatically in the next few months and, hopefully, they will have no more reasons to continue with lock-downs and other restrictions.” Actually the court was merely pointing out that any doc can prescribe the ordinary medications in the protocol (none of which is indicated for COVID-19 outpatients) however he or she sees fit. But it’s a free-for-all – the Piedmont region has now, believe it or not, ordered that COVID-19 outpatients be given that old standby, hydroxychloroquine!