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All Studies   All Outcomes       

Efficacy of Nirmatrelvir/Ritonavir (Paxlovid) for COVID-19 in Vaccinated Patients With Inflammatory Bowel Disease

Mikhail et al., American Journal of Gastroenterology, doi:10.14309/01.ajg.0001082744.48729.45
Dec 2024  
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Progression 0% Improvement Relative Risk Hospitalization 33% Paxlovid for COVID-19  Mikhail et al.  EARLY TREATMENT Is early treatment with paxlovid beneficial for COVID-19? Retrospective 2,773 patients in the USA Lower hospitalization with paxlovid (not stat. sig., p=0.14) c19early.org Mikhail et al., American J. Gastroente.., Dec 2024 Favorspaxlovid Favorscontrol 0 0.5 1 1.5 2+
PSM retrospective 2,773 IBD patients showing no significant difference in hospitalization or the composite outcome of ICU admission, intubation, or mortality with paxlovid treatment. Authors do not specify exclusion of contraindicated patients from the control group which may result in overestimating efficacy.
Resistance. Variants may be resistant to paxlovid1-3. Use may promote the emergence of variants that weaken host immunity and potentially contribute to long COVID4.
Confounding by contraindication. Hoertel et al. find that over 50% of patients that died had a contraindication for the use of Paxlovid5. Retrospective studies that do not exclude contraindicated patients may significantly overestimate efficacy.
Black box warning. The FDA notes that "severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with paxlovid"6.
AKI. Kamo et al. show significantly increased risk of acute kidney injury.
risk of progression, no change, OR 1.00, p = 0.97, treatment 1,166, control 1,607, ICU admission, intubation, or mortality, RR approximated with OR.
risk of hospitalization, 33.0% lower, OR 0.67, p = 0.14, treatment 1,166, control 1,607, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Mikhail et al., 12 Dec 2024, retrospective, USA, peer-reviewed, 8 authors.
This PaperPaxlovidAll
Efficacy of Nirmatrelvir/Ritonavir (Paxlovid) for COVID-19 in Vaccinated Patients With Inflammatory Bowel Disease
Inas Mikhail, Aakash Desai, Sheena Crosby, Jana G Hashash, Mary Hayney, Freddy Caldera, Gursimran Kochhar, Francis A A Farraye
Background: Obefazimod (Obe) is an oral, once-daily (od) small molecule that enhances expression of microRNA-124 and is in phase 3 trials for moderately to severely active ulcerative colitis (UC). Obe showed efficacy and safety at week 8 in a placebo-controlled Phase 2b induction trial and a subsequent open-label maintenance (OLM) study. This post hoc analysis reports corticosteroid (CS)-free efficacy and safety at weeks 48 and 96 in patients receiving concomitant CS at induction baseline. Methods: In the Phase 2b induction trial, patients received placebo or Obe (25 mg, 50 mg, or 100 mg od) and could enter the optional 96-week OLM study with Obe 50 mg, regardless of clinical response. Patients were monitored monthly for safety and efficacy. At induction trial entry, patients could use concomitant CS if on a stable dose for $2 weeks before screening. CS tapering was recommended but not required at the OLM study baseline. CS-free status was defined as CS withdrawal $12 weeks before assessment. CS-free outcomes, including clinical remission (CR), endoscopic improvement (EI), and endoscopic remission (ER), were evaluated at weeks 48 and 96, along with safety. Results: At induction baseline, 115 patients (out of 252, 46%) received CS. Among patients with CS at induction baseline, CR rates were 56% at week 48 and 52% at week 96. CS-free CR was attained by 37% (43/115) at week 48 and 35% at week 96 within the same cohort. Among the 21 patients that were in CR but did not meet the definition of CS-free at week 48, the Principal Investigator (PI) did not attempt the optional CS tapering for 13 pts. An additional 4 patients were CS free, but for less than 12 weeks before the week 48 endpoint. Among the 20 patients that were in CR but did not meet the definition of CS-free at week 96, the PI did not attempt the optional CS tapering for 8 patients. An additional 7 patients were CS free, but for less than 12 weeks before the week 96 endpoint. EI was achieved by 64% at week 48 and 58% at week 96, with CS-free EI achieved by 44% of patients at week 48 and 39% at week 96. ER was achieved by 33% at week 48 and 31% at week 96, with CS-free ER achieved by 24% of patients at week 48 and 21% at week 96. Among patients with CS at induction baseline, 50% and 39% of patients had FCP , 150 mg/g at weeks 48 and 96, respectively. CS-free patients with FCP , 150 mg/g were 32% at week 48 and 28% at week 96. Overall, the safety profile within this cohort was consistent with the overall study population. Conclusions: Among patients receiving concomitant CS at induction baseline, meaningful proportions achieved CR, EI, and ER at weeks 48 and 96 in the OLM. Notably, a substantial proportion of patients met CS-free efficacy endpoints despite optional CS tapering. Concomitant CS use at induction baseline had no notable effect on the safety profile of Obe.
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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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