COVID-19 Antivirals
In the 28-day, 1,379 patient, Phase II/III, EPIC-HR trial (NCT04960202), where 0.72% of patients treated with the combination of nirmatrelvir and ritonavir were hospitalized with no deaths compared to 6.45% who were hospitalized or died with placebo in unvaccinated patients with mild-to-moderate COVID-19 at risk to progress to severe illness. In the 28-day, 490 patient, Phase III, I-TECH trial (NCT04920942), treatment with ivermectin did not reduce the percentage of patients that progressed to severe COVID-19 in high-risk Malaysian outpatients with COVID-19. Synairgen announced that in the 623 patient, 28-day, Phase III SPRINTER trial (NCT04732949), treatment with SNG001 did not decrease time to hospital discharge compared to placebo in hospitalized patients with COVID-19. COVID-19 Vaccines A CDC analysis found that mothers who complete a two-dose vaccination series with an mRNA COVID-19 vaccine resulted in vaccine effectiveness of 61% in their infants < 6 months old. Limited data showed vaccine effectiveness to be 32% if given during the first 20 weeks of pregnancy and 80% if given from 21 weeks to 2 weeks before delivery. A review of medical records from an Israeli managed care database found that vaccine effectiveness with the Pfizer–BioNTech COVID-19 vaccine in patients who recovered from COVID-19 was 82% in patients 16 to 64 and 60% in patients 65 and older. Sanofi and GSK announced that in the 21,046 patient, Phase III, VAT08 trial (NCT04904549), vaccination with two doses of their COVID-19 vaccine resulted in vaccine efficacy of 57.9% against any symptomatic COVID-19 disease, 75% efficacy against moderate or severe COVID-19 disease and 100% against severe COVID-19 disease and hospitalizations COVID-19 Antibodies GSK and Vir announced that in the 29-day, 754 patient, open-label, Phase III, COMET-TAIL trial (NCT04913675), intramuscular (IM) administration of sotrovimab was non-inferior to intravenous (IV) administration (2.7% vs 1.3%) for the early treatment of mild-to-moderate COVID-19 in high-risk, non-hospitalized adults and adolescents (12 years of age and older). COVID-19 Antibodies
Lilly is developing the monoclonal antibody, bebtelovimab, which preliminary data suggests has activity against the Omicron variant and viruses with mutations to the Omicron variant. Bebtelovimab is being evaluated as a treatment of mild to moderate COVID-19 in high-risk patients.
The FDA postponed the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to discuss dosing of the Pfizer-BioNTech COVID-19 vaccine, in children 6-months to 4 years of age, until data is available on a third dose of the vaccine in young children. Data suggests that a third dose may be needed for children 2 to 5 years old. Data on a third dose is expected to be available in April. In a final analysis of the ENSEMBLE trial, efficacy for the J&J COVID-19 vaccine against moderate to severe–critical COVID-19 was 52.9%, 28 or more days after vaccination. Efficacy was 74.6% to prevent severe–critical COVID-19 Interim results after 29-days from 458 patients enrolled in the NIH sponsored, 12-month, 950 patient, Phase I/II, MixNMatch Study (NCT04889209) examined the results of using a booster dose of the same or a different U.S. authorized COVID-19 vaccine. A booster dose increased antibody titers for all combinations of vaccines received. A CDC analysis of vaccine effectiveness (VE) data from August 2021 to January 2022 found that VE was higher after the third dose than after the second dose but decreased over time. During the Omicron-predominant period, VE against COVID-19–associated urgent care visits and hospitalizations was 87% and 91%. during the 2 months after a third dose. VE decreased to 66% and 78% four months after a third dose. Protection was higher against hospitalizations than urgent care visits. COVID-19 Antibodies and Antivirals
An ICER draft review of drugs that are effective to treat the COVID-19 Omicron variant found the risk for hospitalization or death was reduced by 79% with sotrovimab, 30% with molnupiravir and 88% with Paxlovid. A per protocol analysis of fluvoxamine suggested a 66% reduction in the risk for hospitalization. Due to differences in trial population demographics, ICER did not feel the drugs could be compared based on current evidence. All four drugs were found to be cost effective, with a quality-of-life year gained (QALY) < $100,000. The cost of an averted hospitalization was also < $100,000. COVID-19 Antivirals Redhill announced that in a 437 patient, Phase II/III trial (NCT04467840), treatment with opaganib decreased time to viral RNA clearance by at least 4 days compared to placebo in hospitalized patients with severe COVID-19 pneumonia. A subset analysis of 251 patients with an FiO2 of up to 60% found a 62% reduction in mortality. Another subset analysis of 90 patients who were also treated with remdesivir, and corticosteroids found a 70.2% decrease in mortality with the addition of opaganib (6.98% vs 23.4%). S-217622 is a 3CL protease inhibitor, which blocks replication of SARS-CoV-2. Shionogi is evaluating an oral five-day course of S-217622 for the treatment of COVID-19.
The CDC agreed with the FDA’s full approval of Moderna’s COVID-19 vaccine and recommend it for patients18 years and older. At the request of the FDA, Pfizer and BioNTech have submitted a request to expand their COVID-19 vaccine EUA to include children 6 months to < 5 years of age. If approved, this age group would receive two 3 mcg doses. Data to support a third dose given 8 weeks after the second dose is expected to be submitted in the next few months. The vaccine has full approval for patients 16 years and older. An EUA covers use in patients 5 to 15 years. The FDA has scheduled a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the EUA expansion. In anticipation of approval for the vaccine in the patients 6 months to < 5 years of age, the AMA announced the addition of CPT codes to cover this age group. In a 77 patient study, 57% of infants, whose mothers were vaccinated maintained COVID-19 antibody titers, at 6-months, compared to 8% of infants whose mothers had recovered from COVID-19. COVID-19 Vaccines
The FDA granted full approval for the Moderna COVID-19 vaccine for patients 18 years and older on 1/31/2022. Moderna has given the vaccine the brand name Spikevax. A CDC study of hospitalized adults, from August 2021 to December 2021, found the vaccine effectiveness to prevent COVID-19 hospitalizations was 82% in immunocompetent patients that received two doses of an mRNA vaccine and 97% with three doses. Vaccine effectiveness in immunocompromised patients was 69% with two doses and 97% with three doses. A retrospective of the VAERS database by the CDC found the incidence of myocarditis with an mRNA vaccine to be the highest in young males (12 to 24 years) after their second dose. In a 36-day, 721 patient, Phase II trial (NCT04762680), two doses of the Sanofi-GSK CPVOD-19 vaccine was well tolerated and elicited antibodies in in healthy volunteers and recovered COVID-19 patients. Novavax submitted a request for an Emergency Use Authorization (EUA) for NVX-CoV2373, its COVID-19 vaccine candidate, for individuals 18 years of age and older. NVX-CoV2373 is a protein vaccine that delivers nanoparticles of the SARS-2 spike protein to elicit antibodies. COVID-19 Antibodies A meta-analysis (COMPILE study) of eight COVID-19 convalescent plasma studies enrolling 2,341 patients did not find any clinical improvement with convalescent plasma, but data did support use of real-time individual patient data pooling and meta-analysis during a pandemic. Using data from the COMPILE meta-analysis, researchers identified the characteristics of COVID-19 patients most likely to benefit from treatment with convalescent plasma. This data, called the treatment benefit index (TBI), was used to create a prediction tool, called the Convalescent Plasma Benefit Index Calculator. The TBI divides patients into three groups: substantial benefit from convalescent plasma, moderate benefit, and no expected benefit. The TBI was validated with four external data sets. COVID-19 Antibodies and Antivirals A Japanese in vitro study of the Omicron variant found it to be susceptible to the monoclonal antibodies tixagevimab and cilgavimab (AstraZeneca’s combination), sotrovimab (Vir), and the antivirals remdesivir, molnupiravir and nirmatrelvir plus ritonavir. Omicron was resistant to the monoclonal antibody combinations of casirivimab plus imdevimab (Regeneron) and bamlanivimab plus etesevimab (Lilly). |
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