PMID- 36851598
OWN - NLM
STAT- MEDLINE
DCOM- 20230301
LR  - 20230411
IS  - 1999-4915 (Electronic)
IS  - 1999-4915 (Linking)
VI  - 15
IP  - 2
DP  - 2023 Jan 28
TI  - Molnupiravir and Nirmatrelvir/Ritonavir: Tolerability, Safety, and Adherence in a 
      Retrospective Cohort Study.
LID - 10.3390/v15020384 [doi]
LID - 384
AB  - BACKGROUND: Molnupiravir (MOL) and nirmatrelvir/ritonavir (NIR) were recently 
      approved for the early treatment of COVID-19, but real-life data on tolerability, 
      safety, and adverse events (AEs) are still scarce. METHODS: We conducted a 
      retrospective cohort study including all patients who were prescribed MOL and NIR 
      at the Infectious Diseases Unit of Padua University Hospital, between January and 
      May 2022. Demographic, clinical, and safety variables were recorded. RESULTS: We 
      included 909 patients, 48.3% males and 95.2% vaccinated against SARS-CoV-2. The 
      median age was 73 (IQR: 62-82) years. MOL and NIR were prescribed in 407 (44.8%) 
      and 502 (55.2%) patients, respectively. Overall, 124/909 (13.6%) patients 
      experienced any AEs following antivirals intake: 98/124 (79%) patients reporting 
      adverse events presented grade 1 AEs, 23/124 (18.5%) grade 2 AEs and 3 (2.5%) 
      grade 3 AEs. Treatment discontinuation was recorded in 4.8% of patients. AEs were 
      significantly higher in women, in patients treated with NIR compared to MOL and 
      in people who were not vaccinated. CONCLUSIONS: In our real-life setting, AEs 
      were higher than those reported by clinical trials, and were particularly 
      associated with NIR use and with not being vaccinated. Further analyses are 
      needed to better assess safety of oral antivirals and to define which patient's 
      profile may benefit most from MOL and NIR.
FAU - Mazzitelli, Maria
AU  - Mazzitelli M
AUID- ORCID: 0000-0003-0263-0703
AD  - Infectious and Tropical Diseases Unit, Padua University Hospital, 35128 Padua, 
      Italy.
FAU - Mengato, Daniele
AU  - Mengato D
AUID- ORCID: 0000-0003-1374-1505
AD  - Hospital Pharmacy Department, Padua University Hospital, 35128 Padua, Italy.
FAU - Sasset, Lolita
AU  - Sasset L
AD  - Infectious and Tropical Diseases Unit, Padua University Hospital, 35128 Padua, 
      Italy.
FAU - Ferrari, Anna
AU  - Ferrari A
AUID- ORCID: 0000-0001-6924-6306
AD  - Infectious and Tropical Diseases Unit, Padua University Hospital, 35128 Padua, 
      Italy.
FAU - Gardin, Samuele
AU  - Gardin S
AD  - Infectious and Tropical Diseases Unit, Padua University Hospital, 35128 Padua, 
      Italy.
FAU - Scaglione, Vincenzo
AU  - Scaglione V
AUID- ORCID: 0000-0002-2911-2255
AD  - Infectious and Tropical Diseases Unit, Padua University Hospital, 35128 Padua, 
      Italy.
FAU - Bonadiman, Nicola
AU  - Bonadiman N
AD  - Infectious and Tropical Diseases Unit, Padua University Hospital, 35128 Padua, 
      Italy.
FAU - Calandrino, Lucrezia
AU  - Calandrino L
AD  - Infectious and Tropical Diseases Unit, Padua University Hospital, 35128 Padua, 
      Italy.
FAU - Cavinato, Silvia
AU  - Cavinato S
AD  - Infectious and Tropical Diseases Unit, Padua University Hospital, 35128 Padua, 
      Italy.
FAU - Trivellato, Sabrina
AU  - Trivellato S
AUID- ORCID: 0000-0002-1633-2857
AD  - Hospital Pharmacy Department, Padua University Hospital, 35128 Padua, Italy.
FAU - Venturini, Francesca
AU  - Venturini F
AUID- ORCID: 0000-0003-0396-4377
AD  - Hospital Pharmacy Department, Padua University Hospital, 35128 Padua, Italy.
FAU - Cattelan, Anna Maria
AU  - Cattelan AM
AUID- ORCID: 0000-0003-2869-2945
AD  - Infectious and Tropical Diseases Unit, Padua University Hospital, 35128 Padua, 
      Italy.
LA  - eng
PT  - Journal Article
DEP - 20230128
PL  - Switzerland
TA  - Viruses
JT  - Viruses
JID - 101509722
RN  - YA84KI1VEW (molnupiravir)
RN  - 7R9A5P7H32 (nirmatrelvir)
RN  - O3J8G9O825 (Ritonavir)
RN  - 0 (Antiviral Agents)
SB  - IM
MH  - Male
MH  - Humans
MH  - Female
MH  - Aged
MH  - Retrospective Studies
MH  - *Ritonavir/adverse effects
MH  - *COVID-19
MH  - COVID-19 Drug Treatment
MH  - SARS-CoV-2
MH  - Antiviral Agents/adverse effects
PMC - PMC9962206
OTO - NOTNLM
OT  - COVID-19
OT  - adherence
OT  - adverse drug reaction
OT  - molnupiravir
OT  - nirmatrelvir/ritonavir
OT  - tolerability
COIS- All the authors declare to have not financial or non-financial interest in the 
      publication of this work.
EDAT- 2023/03/01 06:00
MHDA- 2023/03/03 06:00
PMCR- 2023/01/28
CRDT- 2023/02/28 01:39
PHST- 2022/12/29 00:00 [received]
PHST- 2023/01/21 00:00 [revised]
PHST- 2023/01/24 00:00 [accepted]
PHST- 2023/02/28 01:39 [entrez]
PHST- 2023/03/01 06:00 [pubmed]
PHST- 2023/03/03 06:00 [medline]
PHST- 2023/01/28 00:00 [pmc-release]
AID - v15020384 [pii]
AID - viruses-15-00384 [pii]
AID - 10.3390/v15020384 [doi]
PST - epublish
SO  - Viruses. 2023 Jan 28;15(2):384. doi: 10.3390/v15020384.