Paxlovid (nirmatrelvir/ritonavir)
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Structure
- combination of nirmatrelvir (PF-0732133)* & ritonavir
Indications
* patients at average risk for progression to severe disease do not benefit[33]
* significantly lowers rates of hospitalization & death due to Covid-19 in elderly (>= 65 years)[14]
* no evidence of benefit in younger patients[14]
* 51% lower risk of hospitalization within 30 days of Covid-19 diagnosis across all age groups >= 18 years than without Paxlovid[17]
* reduces risk of long Covid-19 regardless of vaccination status (RR=0.74)[19]
- reduces risk of post Covid-19 death (RR=0.52)[19]
* reduces risk of hospitalization (RR=0.6) & death (RR=0.29) among adults age >= 50 years 90% of whom with >= 3 vaccines all during the Omicron wave[24]
* effectively reduces risks of death, hospitalization, death or hospitalization, ED visits, ICU admission, & extra oxygen requirement[25]
* in the Omincron era Feb 1, 2022 - Feb 3, 2023, Paxlovid decreased risk of hospitalization or death in severely immunocompromised patients but not in lower risk patients including elderly > 70 years with serious comordibity[26]
* effect on long Covid-19
- only thromboembolic events seem to be reduced by Paxlovid[29]
- reduction in incidence of long Covid-19 (absolute risk reduction = 4.5%)[30]
- does not reduce risk of long Covid-19[31][34]
Contraindications
- co-administration with drugs highly dependent on CYP3A4 for clearance & for which elevated levels may have serious consequences
- pausing of drug for 8-10 days may permit Paxolovid administration[23]
- co-administration with potent CYP3A4 inducers may reduce nirmatrelvir &/or ritonavir plasma concentrations
- pausing of drug will not permit Paxlovid administration[23]
- see drug interactions below for specific interactions & recommendations
- no improvement vs placebo for Paxlovid as prevention of Covid-19 after high-risk exposure[10]
* alternative agents: molnupiravir (Lagevrio), remdesivir (Veklury)
Dosage
- nirmatrelvir 300 mg + ritonavir 100 mg
- 2 nirmatrelvir 150 mg tablets + 1 ritonavir 100 mg tablet
- tablets taken twice a day for 5 days
Tabs: copackaged nirmatrelvir 150 mg (2 tablets) + ritonavir 100 mg (1 tablet)
Dosage adjustment in renal failure
- for eGFR of 30-60 mL/min
- nirmatrelvir 150 mg (1 tablet) + ritonavir 100 mg twice daily for 5 days
- Paxlovid not recommended if eGFR < 30 mL/min
dose pack: 300 mg nirmatrelvir/100 mg ritonavir & 150 mg nirmatrelvir/100 mg ritonavir
Adverse effects
- dysgeusia, diarrhea, abdominal pain, nausea
- hypertension. myalgia, malaise
- anaphylaxis, hypersensitivity
- hepatotoxicity: hepatic transaminase elevations, clinical hepatitis, & jaundice may result from ritonavir (also see ritonavir)
- resistance to HIV protease inhibitors
- some patients experience viral rebound after taking Paxlovid[10][12]
- more-severe COVID-19 increases risk of rebound[32]
- most cases mild, but reports of severe cases
- rebound in SARS-CoV2 RNA around 10-12 days after initial confirmation
- symptom recurrence common after 2 consecutive symptom-free days without Paxlovid[16]
- uncommon among Paxlovid users (1.0% vs 0.6% for non-users)[21]
- neither of 2 Paxlovid users & 12 of 68 non-users with viral rebound died of Covid-19[21]
- symptomatic rebound in 32% of 130 Paxlovid users vs 20% of 241 non-users[32]
- virologic rebound
- no increased risk of rebound[25]
- emergence of SARS-CoV-2 strains resistant to nirmatrelvir after treatment with Paxlovid is rare, independent of virologic rebound[35]
Drug interactions
- derived from ref[23]
- ritonavir is an inhibitor of CYP3A4 (see ritonavir)
- increases concentration of drugs metabolized by CYP3A4
- both nirmatrelvir & ritonavir are substrates of CYP3A4
- 80% of CYP3A4 activity resolves within 3 days of stopping ritonavir, thus most paused medications can be resumed 3 days after 5 days of Paxlovid, & if no harm from the brief pause, 5 days after[23]
- strong CYP3A4 inhibitors will not result in a clinically significant increase in nirmatrelvir/ritonavir concentrations[23]
- strong inducers of CYP3A4 may reduce efficacy of nirmatrelvir[23]
- alphabetical listing of interacting & potentially interacting medications sorted by generic name (see below for listing sorted by Tradename)*[23]
- Abemaciclib (Verzenio) - potential interaction, consider pause 8 days*
- Acalabrutinib (Calquence) - pause 8 days*
- Afatinib (Gilotrif) - potential interaction, consider pause 8 days
- Alfuzosin (Uroxatral) - pause 8 days
- Aliskiren (Tekturna, Rasilez) - pause 8 days
- Alprazolam (Xanax, Niravam) - potential interaction, consider pause 8 days
- Amiodarone (Cordarone, Pacerone) - Paxlovid contraindicated due to prolonged 1/2life
- Apalutamide (Erleada) - Paxlovid contraindicated due to strong CYP3A4 inducer
- Apixaban (Eliquis) - pause 8 days
- Aprepitant (Emend) - potential interaction, consider pause 8 days
- Aripiprazole (Abilify) - potential interaction, consider pause 8 days
- Atorvastatin (Lipitor) - potential interaction, consider pause 8 days
- Avanafil (Stendra)
- Bepridil (Vascor, Angopril, Cordium) - pause 8 days
- Bosentan (Tracleer) - pause 8 days
- Bosutinib (Bosulif) - pause 8 days
- Buspirone (BuSpar) - potential interaction, consider pause 8 days
- Carbamazepine* (Tegretol) - Paxlovid contraindicated due to strong CYP3A4 inducer[23]
- Ceritinib, pelitinib (Zykadia)- potential interaction, consider pause 8 days
- Cisapride (Propulsid) - pause 8 days
- Cladrabine (Leustatin) - potential interaction, consider pause 8 days
- Clobazam (ONFI, Frisium, Urbanol) - potential interaction, consider pause 8 days
- Clonazepam (Klonopin)
- Clopidogrel (Plavix) - pause 8 days
- Clorazepate (Tranxene) - pause 8 days
- Clozapine (Clozaril) - pause 8 days
- Colchicine (Colcrys) in patients with renal &/or hepatic impairment - pause 8 days
- Codeine (Phenergan)
- Cyclosporine, cyclosporine-A (Sandimmune, Neoral) - pause 8 days
- Dabigatran (Pradaxa) - potential interaction, consider pause 8 days
- Dasatinib (Sprycel) - potential interaction, consider pause 8 days
- Dextropropoxyphene (Dolene) - pause 8 days
- Diazepam (Vallium) - pause 8 days
- Digoxin (Lanoxin) - potential interaction, consider pause 8 days
- Disopyramide (Norpace) - pause 8 days
- Dofetilide (Tikosyn)- pause 8 days
- Domperidone (Motilium) - pause 8 days
- Dronedarone (Multaq) - pause 8 days
- Edoxaban (Savaysa) - potential interaction, consider pause 8 days
- Elbasvir/grazoprevir (Zepatier) - pause 8 days
- Encorafenib (Mektovi)- potential interaction, consider pause 8 days
- Enzalutamide (Xtandi) - Paxlovid contraindicated due to strong CYP3A4 inducer
- Eplerenone (Inspra)
- Ergot derivatives, ergometrine, ergotamine ((Migranal, Trudhesa) - pause 8 days
- Erlotinib (Tarceva) - potential interaction, consider pause 8 days
- Estazolam (ProSom) - pause 8 days
- Ethosuximide (Zarontin) - potential interaction, consider pause 8 days
- Everolimus (Afinitor) - pause 8 days
- Flecainide (Tambocor) - pause 8 days
- Fentanyl (Sublimaze, Fentora... Lazanda)- potential interaction, consider pause 8 days
- Flibanserin (Addyi, Girosa)
- Flunitrazepam (Rohypnol) - potential interaction, consider pause 8 days
- Flurazepam (Dalmane) - pause 8 days
- Fostamatinib (Tavalisse) - potential interaction, consider pause 8 days
- Gilteritinib (Xospata) - potential interaction, consider pause 8 days
- Glecaprevir/pibrentasvir (Mavyret) - pause 8 days
- Haloperidol (Haldol) - potential interaction, consider pause 8 days
- Hydrocodone (Zohydro ER, Hysingla ER)
- Ibrutinib (Imbruvica) - pause 8 days
- Iloperidone, hoperidone (Fanapt) - potential interaction, consider pause 8 days
- Imatinib (Gleevec) - potential interaction, consider pause 8 days
- Ivabradine (Corlanor, Lancora) - pause 8 days
- Ivosidenib (Tibsovo) - Paxlovid contraindicated due to strong CYP3A4 inducer
- Lercanidipine (Zanidip) - pause 8 days
- Lidocaine (Xylocaine) - potential interaction, consider pause 8 days
- Lomitapide (Juxtapid)
- Lovastatin (Mevacor, Altocor, Altoprev)
- Lumateperone (Caplyta) - pause 8 days
- Lurasidone (Latuda) - pause 8 days
- Meperidine, pethidine (Demerol)
- Midazolam, oral (Buccolam) - pause 8 days
- Midostaurin (Rydapt) - pause 8 days
- Mexiletine (Mexitil)
- Neratinib (Nerlynx) - pause 8 days
- Nilotinib (Tasigna) - potential interaction, consider pause 8 days
- Olaparib (Lynparza) - potential interaction, consider pause 8 days
- Oxycodone (Roxicodone, OxyContin ...) - potential interaction, consider pause 8 days
- Palbociclib (Ibrance) - potential interaction, consider pause 8 days
- Pazopanib (Votrient) - potential interaction, consider pause 8 days
- Phenprocoumon (Marcoumar...) - potential interaction, consider pause 8 days
- Phenobarbital (Luminal...) - Paxlovid contraindicated due to strong CYP3A4 inducer
- Phenytoin (Dilantin...) - Paxlovid contraindicated due to strong CYP3A4 inducer
- Pimozide (Orap) - pause 8 days
- Piroxicam (Feldene)
- Primidone (Mysoline...) - Paxlovid contraindicated due to strong CYP3A4 inducer
- Propafenone (Rythmol, Baxarytmon) - pause 8 days
- Propoxyphene (Darvon)
- Quetiapine (Seroquel) - pause 8 days
- Quinidine (Quinaglute, Quinalan, Quinidex, Quinora)- pause 8 days
- Ranolazine (Ranexa) - pause 8 days
- Reboxetine (Vestra, Edronax...) - potential interaction, consider pause 8 days
- Ribociclib (Kisqali) - potential interaction, consider pause 8 days
- Riociguat (Adempas) - potential interaction, consider pause 8 days
- Rifampin/Rifampicin (Rifadin) - Paxlovid contraindicated due to strong CYP3A4 inducer
- Rifapentine (Priftin) - Paxlovid contraindicated due to strong CYP3A4 inducer
- Rivaroxaban (Xarelto) - pause 8 days
- Rosuvastatin (Crestor) - potential interaction, consider pause 8 days
- Salmeterol (Serevent) - pause 8 days
- Saxagliptin (Onglyza) - potential interaction, consider pause 8 days
- Sildenafil for pulmonary hypertension (Revatio) - pause 8 days
- Silodosin (Rapaflo)
- Simvastatin (Zocor) - pause 8 days, metabolized 100% by CYP3A4
- Sirolimus, rapamycin (Rapamune) - pause 8 days
- Sofosbivir/velpatasvir/voxilaprevir (Vosevi) - potential interaction, consider pause 8 days
- Suvorexant (Belsomra)
- St. John's wort (Hypericum perforatum) - Paxlovid contraindicated due to strong CYP3A4 inducer
- Sunitinib (Sutent) - potential interaction, consider pause 8 days
- Tacrolimus* (Prograf...) - pause 8 days, therapeutic drug monitoring[22][23]
- Tadalafil for erectile dysfunction (Cialis)
- Tadalafil for pulmonary hypertension (Adcirca) - pause 8 days
- Tamsulosin (Flomax, Urolosin)
- Tiagabine (Gabitril) - potential interaction, consider pause 8 days
- Ticagrelor (Brilinta) - pause 8 days
- Tramadol (Ultram)
- Trazodone (Desyrel...) - potential interaction, consider pause 8 days
- Triazolam (Halcion) - pause 8 days
- Vardenafil (Levitra, Staxyn)
- Vinblastine (Velban, Velsar)- potential interaction, consider pause 8 days
- Vincristine (Oncovin)- potential interaction, consider pause 8 days
- Venetoclax (Venclexta) - pause 8 days
- Voclosporin (Lupkynistm) - pause 8 days
- Vorapaxar (Zontivity)
- Warfarin (Coumadin)- potential interaction, consider pause 8 days
* Tradename(s) in parentheses
* no action needed unless specified
* pause of 8 days: pause during Paxlovid administration + 3 days after
- same alphabetical listing sorted by Tradename
- (Abilify) Aripiprazole - potential interaction, consider pause 8 days
- (Adcirca) Tadalafil for pulmonary hypertension - pause 8 days
- (Addyi, Girosa) Flibanserin
- (Adempas) Riociguat - potential interaction, consider pause 8 days
- (Afinitor) Everolimus - pause 8 days
- (Altocor, Mevacor, Altoprev) Lovastatin
- (Altoprev, Mevacor, Altocor) Lovastatin
- (Angopril, Vascor, Cordium) Bepridil - pause 8 days
- (Baxarytmon, Rythmol) Propafenone - pause 8 days
- (Belsomra) Suvorexant
- (Bosulif) Bosutinib - pause 8 days
- (Brilinta) Ticagrelor - pause 8 days
- (Buccolam) Midazolam, oral - pause 8 days
- (BuSpar) Buspirone - potential interaction, consider pause 8 days
- (Calquence) Acalabrutinib - pause 8 days*
- (Caplyta) Lumateperone - pause 8 days
- (Cialis) Tadalafil for erectile dysfunction
- (Clozaril) Clozapine - pause 8 days
- (Colcrys) Colchicine in patients with renal &/or hepatic impairment - pause 8 days
- (Cordarone, Pacerone) Amiodarone - Paxlovid contraindicated due to prolonged 1/2life
- (Cordium, Angopril, Vascor) Bepridil - pause 8 days
- (Corlanor, Lancora) Ivabradine - pause 8 days
- (Coumadin) Warfarin - potential interaction, consider pause 8 days
- (Crestor) Rosuvastatin - potential interaction, consider pause 8 days
- (Dalmane) Flurazepam - pause 8 days
- (Darvon) Propoxyphene
- (Demerol) Meperidine, pethidine
- (Desyrel...) Trazodone - potential interaction, consider pause 8 days
- (Dilantin...) Phenytoin - Paxlovid contraindicated due to strong CYP3A4 inducer
- (Dolene) Dextropropoxyphene - pause 8 days
- (Edronax, Vestra ...) Reboxetine - potential interaction, consider pause 8 days
- (Eliquis) Apixaban - pause 8 days
- (Emend) Aprepitant - potential interaction, consider pause 8 days
- (Erleada) Apalutamide - Paxlovid contraindicated due to strong CYP3A4 inducer
- (Fanapt) Iloperidone, hoperidone - potential interaction, consider pause 8 days
- (Feldene) Piroxicam
- (Fentora, Sublimaze, Lazanda ...) Fentanyl - potential interaction, consider pause 8 days
- (Flomax, Urolosin) Tamsulosin
- (Frisium, ONFI, Urbanol) Clobazam - potential interaction, consider pause 8 days
- (Gabitril) Tiagabine - potential interaction, consider pause 8 days
- (Gilotrif) Afatinib - potential interaction, consider pause 8 days
- (Girosa, Addyi) Flibanserin
- (Gleevec) Imatinib - potential interaction, consider pause 8 days
- (Halcion) Triazolam - pause 8 days
- (Haldol) Haloperidol - potential interaction, consider pause 8 days
- (Hypericum perforatum) St. John's wort - Paxlovid contraindicated due to strong CYP3A4 inducer
- (Hysingla ER, Zohydro ER) Hydrocodone
- (Ibrance) Palbociclib - potential interaction, consider pause 8 days
- (Imbruvica) Ibrutinib - pause 8 days
- (Inspra) Eplerenone
- (Juxtapid) Lomitapide
- (Kisqali) Ribociclib - potential interaction, consider pause 8 days
- (Klonopin) Clonazepam
- (Lancora, Corlanor) Ivabradine - pause 8 days
- (Lanoxin) Digoxin - potential interaction, consider pause 8 days
- (Latuda) Lurasidone - pause 8 days
- (Lazanda, Sublimaze, Fentora ...) Fentanyl - potential interaction, consider pause 8 days
- (Leustatin) Cladrabine - potential interaction, consider pause 8 days
- (Levitra, Staxyn) Vardenafil
- (Lipitor) Atorvastatin - potential interaction, consider pause 8 days
- (Luminal...) Phenobarbital - Paxlovid contraindicated due to strong CYP3A4 inducer
- (Lupkynistm) Venetoclax - pause 8 days
- (Lynparza) - potential interaction, consider pause 8 days
- (Marcoumar...) Phenprocoumon - potential interaction, consider pause 8 days
- (Mavyret) Glecaprevir/pibrentasvir - pause 8 days
- (Mektovi) Encorafenib - potential interaction, consider pause 8 days
- (Mevacor, Altocor, Altoprev) Lovastatin
- (Mexitil) Mexiletine
- (Migranal, Trudhesa) Ergot derivatives, ergometrine, ergotamine - pause 8 days
- (Motilium) Domperidone - pause 8 days
- (Multaq) Dronedarone - pause 8 days
- (Mysoline...) Primidone - Paxlovid contraindicated due to strong CYP3A4 inducer
- (Neoral, Sandimmune) Cyclosporine, cyclosporine-A - pause 8 days
- (Nerlynx) Neratinib - pause 8 days
- (Niravam, Xanax) Alprazolam - potential interaction, consider pause 8 days
- (Norpace) Disopyramide - pause 8 days
- (Oncovin) Vincristine - potential interaction, consider pause 8 days
- (ONFI, Frisium, Urbanol) Clobazam - potential interaction, consider pause 8 days
- (Onglyza) Saxagliptin - potential interaction, consider pause 8 days
- (Orap) Pimozide - pause 8 days
- (OxyContin, Roxicodone ...) Oxycodone - potential interaction, consider pause 8 days
- (Pacerone, Cordarone) Amiodarone - Paxlovid contraindicated due to prolonged 1/2life
- (Phenergan) Codeine
- (Plavix) Clopidogrel - pause 8 days
- (Pradaxa) Dabigatran - potential interaction, consider pause 8 days
- (Priftin) Rifapentine - Paxlovid contraindicated due to strong CYP3A4 inducer
- (Prograf...) Tacrolimus* - pause 8 days, therapeutic drug monitoring[22][23]
- (Propulsid) Cisapride - pause 8 days
- (ProSom) Estazolam - pause 8 days
- (Quinaglute, Quinalan, Quinidex, Quinora) Quinidine - pause 8 days
- (Ranexa) Ranolazine - pause 8 days
- (Rapaflo) Silodosin
- (Rapamune) Sirolimus, rapamycin - pause 8 days
- (Rasilez, Tekturna) Aliskiren - pause 8 days
- (Revatio) Sildenafil for pulmonary hypertension - pause 8 days
- (Rifadin) Rifampin/Rifampicin - Paxlovid contraindicated due to strong CYP3A4 inducer
- (Rohypnol) Flunitrazepam - potential interaction, consider pause 8 days
- (Roxicodone, OxyContin ...) Oxycodone - potential interaction, consider pause 8 days
- (Rydapt) Midostaurin - pause 8 days
- (Rythmol, Baxarytmon) Propafenone - pause 8 days
- (Sandimmune, Neoral) Cyclosporine, cyclosporine-A - pause 8 days
- (Savaysa) Edoxaban - potential interaction, consider pause 8 days
- (Serevent) Salmeterol - pause 8 days
- (Seroquel) Quetiapine - pause 8 days
- (Sprycel) Dasatinib - potential interaction, consider pause 8 days
- (Staxyn, Levitra) Vardenafil
- (Stendra) Avanafil
- (Sublimaze, Fentora, Lazanda ...) Fentanyl - potential interaction, consider pause 8 days
- (Sutent) Sunitinib - potential interaction, consider pause 8 days
- (Tambocor) Flecainide - pause 8 days
- (Tarceva) Erlotinib - potential interaction, consider pause 8 days
- (Tasigna) Nilotinib - potential interaction, consider pause 8 days
- (Tavalisse) Fostamatinib - potential interaction, consider pause 8 days
- (Tegretol) Carbamazepine* - Paxlovid contraindicated due to strong CYP3A4 inducer[23]
- (Tekturna, Rasilez) Aliskiren - pause 8 days
- (Tibsovo) Ivosidenib - Paxlovid contraindicated due to strong CYP3A4 inducer
- (Tikosyn) Dofetilide - pause 8 days
- (Tracleer) Bosentan - pause 8 days
- (Tranxene) Clorazepate - pause 8 days
- (Trudhesa, Migranal) Ergot derivatives, ergometrine, ergotamine - pause 8 days
- (Ultram) Tramadol
- (Urbanol, ONFI, Frisium) Clobazam - potential interaction, consider pause 8 days
- (Urolosin, Flomax) Tamsulosin
- (Uroxatral) Alfuzosin - pause 8 days
- (Vallium) Diazepam - pause 8 days
- (Vascor, Angopril, Cordium) Bepridil - pause 8 days
- (Velban, Velsar) Vinblastine - potential interaction, consider pause 8 days
- (Venclexta) Venetoclax - pause 8 days
- (Verzenio) Abemaciclib - potential interaction, consider pause 8 days*
- (Vestra, Edronax...) Reboxetine - potential interaction, consider pause 8 days
- (Vosevi) Sofosbivir/velpatasvir/voxilaprevir - potential interaction, consider pause 8 days
- (Votrient) Pazopanib - potential interaction, consider pause 8 days
- (Xanax, Niravam) Alprazolam - potential interaction, consider pause 8 days
- (Xarelto) Rivaroxaban - pause 8 days
- (Xospata) Gilteritinib - potential interaction, consider pause 8 days
- (Xtandi) Enzalutamide - Paxlovid contraindicated due to strong CYP3A4 inducer
- (Xylocaine) Lidocaine - potential interaction, consider pause 8 days
- (Zanidip) Lercanidipine - pause 8 days
- (Zarontin) Ethosuximide - potential interaction, consider pause 8 days
- (Zepatier) Elbasvir/grazoprevir - pause 8 days
- (Zocor) Simvastatin - pause 8 days, metabolized 100% by CYP3A4
- (Zohydro ER, Hysingla ER) Hydrocodone
- (Zontivity) Vorapaxar
- (Zykadia) Ceritinib, pelitinib - potential interaction, consider pause 8 days
- drug interaction(s) of antiretroviral protease inhibitor in combination with ritonavir
- drug interaction(s) of boceprevir in combination with ritonavir & Kaletra
- drug interaction(s) of boceprevir in combination with ritonavir & darunavir
- drug interaction(s) of boceprevir in combination with ritonavir & atazanavir
- drug interaction(s) of saquinavir with ritonavir
- drug interaction(s) of eplerenone with ritonavir
Clinical significance
- Pfizer reports Paxlovid is 89% effective, compared to a placebo, at preventing hospitalization or death in patients with COVID-19 who are at high risk of severe complications if given within 3 days of symptom onset[2][5][6]
- NEJM article confirms 89% efficacy[9]
- monitor for effects of drug interactions for 5-day duration of Paxlovid treatment & for at least 3-5 days after treatment completion[8]
- adults prescribed Paxlovid within 5 days of diagnosis had a 51% lower risk of hospitalization within 30 days of diagnosis than without[17]
- reduces risk of hospitalization (RR=0.6) & death (RR=0.29) among adults age >= 50 years 90% of whom with >= 3 vaccines all during the Omicron wave[24]
Mechanism of action
- boosting with ritonavir, a strong CYP3A inhibitor, is required to increase the exposure of nirmatrelvir to a concentration effective against SARS-CoV2[8]
* see ref[3] for structure)
Notes
- free in 2022 & 2023 courtesy of the U.S. government
- Pfizer has said it will price Paxlovid in 2024 at $1390 for the 5 day course
- U.S. government has so far purchased 20 million courses of Paxlovid, priced at ~$530 each, a discount for buying in bulk[20]
- nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government[20]
- Pfizer has applied for full FDA approval of Paxlovid in June of 2022, but so far only emergency use authorization has been granted[20]
- federal law restricts Medicare Part D from covering medications without full FDA-approval[20]
More general terms
Additional terms
Components
References
- ↑ Pfizer Press Release. Nov 5, 2021 Pfizer's Novel COVID-19 Oral Antiviral Treatment Candidate Reduced Risk of Hospitalization or Death by 89% in Interim Analysis of Phase 2/3 EPIC-HR Study. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate
- ↑ 2.0 2.1 Goodman B Pfizer Says Its COVID-19 Pill Is Highly Effective. Medscape. November 05, 2021 https://www.medscape.com/viewarticle/962390
- ↑ 3.0 3.1 Halford B Pfizer unveils its oral SARS-CoV-2 inhibitor. Chemical & Engineering News. April 7, 2021 https://cen.acs.org/acs-news/acs-meeting-news/Pfizer-unveils-oral-SARS-CoV/99/i13
- ↑ A Study of PF-07321332/Ritonavir in Nonhospitalized High Risk Adult Participants With COVID-19. ClinicalTrial.gov https://clinicaltrials.gov/ct2/show/NCT04960202
- ↑ 5.0 5.1 AMA Morning Rounds. November 8, 2021
New York Times https://www.nytimes.com/2021/11/05/health/pfizer-covid-pill.html
Johnson CY Antiviral pills from Pfizer, Merck, show promise against worst covid-19 outcomes. Washington Post. November 5, 2021 https://www.washingtonpost.com/health/2021/11/05/pfizer-covid-pill/ - ↑ 6.0 6.1 Erman M, Beasley D Pfizer Says COVID-19 Pill Near 90% Effective in Final Analysis. Medscape. December 14, 2021 https://www.medscape.com/viewarticle/964750
- ↑ McNamara D FDA Authorizes Pfizer Antiviral Pill for COVID-19. Medscape. December 22, 2021 https://www.medscape.com/viewarticle/965398
- ↑ 8.0 8.1 8.2 Pearson A Caution: Paxlovid Interacts With Many Heart Meds. The Skeptical Cardiologist asks clinicians and patients to take note. MedPage Today. Jan 17, 2022 https://www.medpagetoday.com/opinion/skeptical-cardiologist/96692
NIH Coovid-19 Treatment Guidelines. Dec 30, 2021 The COVID-19 Treatment Guidelines Panel's Statement on Potential Drug-Drug Interactions Between Ritonavir-Boosted Nirmatrelvir (Paxlovid) and Concomitant Medications. Statement on Paxlovid Drug-Drug Interactions https://www.covid19treatmentguidelines.nih.gov/therapies/statement-on-paxlovid-drug-drug-interactions/ - ↑ 9.0 9.1 Hammond J, Leister-Tebbe H, Gardner A et al Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022. Feb 16. PMID: https://www.ncbi.nlm.nih.gov/pubmed/35172054 https://www.nejm.org/doi/full/10.1056/NEJMoa2118542
- ↑ 10.0 10.1 10.2 Walker M NIH Probes Palovid Relapses; Pandemic of the Unvaxxed No More? Musk Disses Wellbutrin. A daily roundup of news on Covid-19 and the rest of medicine. MedPage Today May 2, 2022 https://www.medpagetoday.com/infectiousdisease/covid19/98500
- ↑ Ganio M Paxlovid Is Here: A Pharmacist's Prescribing Pearls. Medscape. May 03, 2022 https://www.medscape.com/viewarticle/973260
- ↑ 12.0 12.1 Fiore K What Do We Know About Paxlovid Rebound? And how should clinicians handle relapses after a 5-day course? MedPage Today May 6, 2022 https://www.medpagetoday.com/special-reports/exclusives/98584
- ↑ Centers for Disease Control & Prevention (CDC) Health Alet Network. May 24, 2022 COVID-19 Rebound After Paxlovid Treatment. https://emergency.cdc.gov/han/2022/han00467.asp
- ↑ 14.0 14.1 14.2 Hein I Far Fewer Deaths During Omicron for Seniors Treated With Paxlovid.
Little apparent effect observed in patients ages 40 to 64, however. MedPage Today August 24, 2022 https://www.medpagetoday.com/infectiousdisease/covid19/100382
Arbel R, Wolff Sagy Y, Hoshen M et al Nirmatrelvir Use and Severe Covid-19 Outcomes during the Omicron Surge. N Engl J Med. 2022. Aug 24. Not yet indeed in PubMed https://www.nejm.org/doi/full/10.1056/NEJMoa2204919 - ↑ Bronze MS Rapid Review Quiz: COVID-19 Updates Medscape. September 28, 2022 https://reference.medscape.com/viewarticle/980879
Arbel R, Sagy WY, Hoshen M et al Nirmatrelvir Use and Severe Covid-19 Outcomes during the Omicron Surge. N Engl J Med. 2022 Sep 1;387(9):790-798. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36001529 PMCID: PMC9454652 Free PMC article https://www.nejm.org/doi/10.1056/NEJMoa2204919 - ↑ 16.0 16.1 Smith DM, Li JZ, Moser C et al Recurrence of Symptoms Following a 2-Day Symptom Free Period in Patients With COVID-19. JAMA Netw Open. 2022;5(10):e2238867. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36301549 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2797789
- ↑ 17.0 17.1 17.2 Phend C Paxlovid Vindicated for Younger COVID Patients. CDC study supports similar benefit in those under 50 as in seniors. MedPage Today November 22, 2022 https://www.medpagetoday.com/infectiousdisease/covid19/101874
Shah MM, Joyce B, Plumb ID et al. Paxlovid Associated with Decreased Hospitalization Rate Among Adults with COVID-19 - United States, April-September 2022. MMWR Morb Mortal Wkly Rep. ePub: 22 November 2022 https://www.cdc.gov/mmwr/volumes/71/wr/mm7148e2.htm - ↑ Topol E Paxlovid and Long COVID. Medscape. Nov 08, 2022 https://www.medscape.com/viewarticle/983718
- ↑ 19.0 19.1 19.2 Xie Y, Choi T, Al-Aly Z Nirmatrelvir and the Risk of Post-Acute Sequelae of COVID-19. medRxiv. Nov 5, 2022 https://www.medrxiv.org/content/10.1101/2022.11.03.22281783v1
- ↑ 20.0 20.1 20.2 20.3 20.4 Recht H Paxlovid Has Been Free So Far. Next Year, Sticker Shock Awaits. Kaiser Health News (KHN). Dec 7, 2023 https://khn.org/news/article/paxlovid-covid-sticker-shock-insurance/
- ↑ 21.0 21.1 21.2 Wong GL, Yip TC, Lai MS, Wong VW, Hui DS, Lui GC Incidence of Viral Rebound After Treatment With Nirmatrelvir-Ritonavir and Molnupiravir. JAMA Netw Open. 2022;5(12):e2245086. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36472873 Free article. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2799218
- ↑ 22.0 22.1 22.2 Prikis M, Cameron A. Paxlovid (Nirmatelvir/Ritonavir) and Tacrolimus Drug-Drug Interaction in a Kidney Transplant Patient with SARS-2-CoV infection: A Case Report. Transplant Proc. 2022 Jul-Aug;54(6):1557-1560. Epub 2022 May 20. PMID: https://www.ncbi.nlm.nih.gov/pubmed/35599203 Free PMC article.
- ↑ 23.00 23.01 23.02 23.03 23.04 23.05 23.06 23.07 23.08 23.09 23.10 23.11 23.12 Marzolini C, Kuritzkes DR, Marra F Recommendations for the Management of Drug-Drug Interactions Between the COVID-19 Antiviral Nirmatrelvir/Ritonavir (Paxlovid) and Comedications. Clin Pharmacol Ther. 2022 Dec;112(6):1191-1200 PMID: https://www.ncbi.nlm.nih.gov/pubmed/35567754 PMCID: PMC9348462 Free PMC article
- ↑ 24.0 24.1 24.2 Dryden-Peterson S, Kim A, Kim AY et al Nirmatrelvir Plus Ritonavir for Early COVID-19 in a Large U.S. Health System. A Population-Based Cohort Study. Ann Intern Med. 2022. Dec 13 PMID: https://www.ncbi.nlm.nih.gov/pubmed/36508742 PMCID: PMC9753458 Free PMC article https://www.acpjournals.org/doi/10.7326/M22-2141
- ↑ 25.0 25.1 25.2 Tian H, Yang C, Song T et al Efficacy and safety of paxlovid (nirmatrelvir/ritonavir) in the treatment of COVID-19: An updated meta-analysis and trial sequential analysis. Rev Med Virol. 2023 Jul 23;e2473. PMID: https://www.ncbi.nlm.nih.gov/pubmed/37485774 https://onlinelibrary.wiley.com/doi/10.1002/rmv.2473
- ↑ 26.0 26.1 Dormuth CR, Kim JD, Fisher A et al Nirmatrelvir-Ritonavir and COVID-19 Mortality and Hospitalization Among Patients With Vulnerability to COVID-19 Complications. JAMA Netw Open. 2023;6(10):e2336678 PMID: https://www.ncbi.nlm.nih.gov/pubmed/37782496 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2809972
- ↑ Erman M Pfizer to Price COVID Treatment Paxlovid at $1390 Per Course. Medscape. Oct 19, 2024
- ↑ 28.0 28.1 Edelstein GE et al. SARS-CoV-2 virologic rebound with nirmatrelvir-ritonavir therapy: An observational study. Ann Intern Med 2023 Nov 14; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/37956428 PMCID: PMC10644265 Free PMC article https://www.acpjournals.org/doi/10.7326/M23-1756
Cohen MS, Brown ER. Rebound of COVID-19 with nirmatrelvir-ritonavir antiviral therapy. Ann Intern Med 2023 Nov 14; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/37956432 PMCID: PMC10644264 Free PMC article https://www.acpjournals.org/doi/10.7326/M23-2887 - ↑ 29.0 29.1 Ioannou GN, Berry K, Rajeevan N et al Effectiveness of Nirmatrelvir-Ritonavir Against the Development of Post-Covid-19 Conditions Among U.S. Veterans. A Target Trial Emulation. Ann Intern Med 2023 Nov;176(11):1486-1497 PMID: https://www.ncbi.nlm.nih.gov/pubmed/37903369 PMCID: PMC10620954 Free PMC article https://acp-prod.literatumonline.com/doi/full/10.7326/M23-1394
- ↑ 30.0 30.1 Fung KW, Baye F, Baik SH, McDonald CJ. Nirmatrelvir and Molnupiravir and Post-COVID-19 Condition in Older Patients. JAMA Intern Med. 2023 Dec 1;183(12):1404-1406 PMID: https://www.ncbi.nlm.nih.gov/pubmed/37870856 PMCID: PMC10594174 Free PMC article https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2811092
- ↑ 31.0 31.1 Durstenfeld MS, Peluso MJ, Lin F et al Association of nirmatrelvir for acute SARS-CoV-2 infection with subsequent Long COVID symptoms in an observational cohort study. J Med Virol 2024. 96(1):e29333. Jan 4. PMID: https://www.ncbi.nlm.nih.gov/pubmed/38175151 PMCID: PMC10786003 (available on 2025-01-01) https://onlinelibrary.wiley.com/doi/10.1002/jmv.29333
- ↑ 32.0 32.1 32.2 32.3 Smith-Jeffcoat SE et al. Symptoms, viral loads, and rebound among coronavirus disease 2019 (COVID-19) outpatients treated with nirmatrelvir/ritonavir compared with propensity score- matched untreated individuals. Clin Infect Dis 2023 Nov 14; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/37963102 https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciad696/7420299
- ↑ 33.0 33.1 Hammond J et al. Nirmatrelvir for vaccinated or unvaccinated adult outpatients with Covid-19. N Engl J Med 2024;390:1186-1195 Apr 3. PMID: https://www.ncbi.nlm.nih.gov/pubmed/38598573 https://www.nejm.org/doi/10.1056/NEJMoa2309003
Gandhi RT, Hirsch M. Treating acute Covid-19 - Final chapters still unwritten. N Engl J Med 2024;390:1234-1236 Apr 3 PMID: https://www.ncbi.nlm.nih.gov/pubmed/38598581 https://www.nejm.org/doi/10.1056/NEJMe2402224 - ↑ 34.0 34.1 Geng LN, Bonilla H, Hedlin H et al Nirmatrelvir-Ritonavir and Symptoms in Adults With Postacute Sequelae of SARS-CoV-2 Infection: The STOP-PASC Randomized Clinical Trial. JAMA Intern Med. 2024 Jun 7:e242007. PMID: https://www.ncbi.nlm.nih.gov/pubmed/38848477 PMCID: PMC11161857 Free PMC article. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11161857/
- ↑ 35.0 35.1 Tamura TJ, Choudhary MC, Deo R et al Emerging SARS-CoV-2 Resistance After Antiviral Treatment. JAMA Netw Open. 2024 Sep 3;7(9):e2435431. PMID: https://www.ncbi.nlm.nih.gov/pubmed/39320890 PMCID: PMC11425144 Free PMC article. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2824050
- ↑ HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION PAXLOVID (nirmatrelvir tablets; ritonavir tablets), co-packaged for oral use https://www.fda.gov/media/155050/download