PMID- 38344519
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240213
IS  - 2168-8184 (Print)
IS  - 2168-8184 (Electronic)
IS  - 2168-8184 (Linking)
VI  - 16
IP  - 1
DP  - 2024 Jan
TI  - Real-World Safety of TwinRab, the World's First Novel Cocktail of Rabies 
      Monoclonal Antibodies, in a Clinical Setting.
PG  - e52163
LID - 10.7759/cureus.52163 [doi]
LID - e52163
AB  - OBJECTIVES: Every year, 18,000-20,000 people die from rabies in India, with 
      children younger than the age of 15 accounting for 30%-60% of all cases. Wound 
      cleaning, vaccination, and rabies immunoglobulin (RIG) administration are all 
      part of treatment. TwinRab(TM), a unique combination of two monoclonal antibodies 
      (mAbs), docaravimab and miromavimab, effectively neutralizes rabies and 
      rabies-like viruses. We conducted this study to evaluate the safety of the 
      cocktail in patients infected with category-III animal bites according to WHO 
      guidelines. METHODS: This open-label observational study was conducted in 
      patients with WHO category-III animal bites by suspected rabid animals. All 
      participants were screened, enrolled, and were administered the TwinRab(TM) 
      manufactured by Zydus Lifesciences Ltd. at the rate of 40 IU/kg by infiltration 
      in and around the wound along with anti-rabies vaccine (ARVs). Participants were 
      assessed at various intervals, and any adverse events (AEs) were documented and 
      reported to the sponsor within 24 hours. RESULT: The study enrolled 401 
      participants, 55.61% (n = 223) male, whose median age was 34 years. Adults made 
      up 69.83% (n = 280) of the participants. The most exposed sites were the lower 
      parts of the body (60.6%, n = 243); 99.75% (n = 400) of the population showed 
      normal cardiovascular, gastrointestinal, and central nervous systems. After seven 
      days of the last postexposure prophylaxis (PEP) dose, 9.98% of the total study 
      population experienced 80 mild local solicited AEs and were assessed and treated. 
      CONCLUSION: The study concluded that TwinRab(TM) when given in a 40 IU/kg dose 
      with Essen or the updated Thai Red Cross Vaccine regimen, provides safe and 
      effective rabies prophylaxis in WHO category III patients exposed to suspected 
      rabied animal bites.
CI  - Copyright (c) 2024, Manna et al.
FAU - Manna, Asis
AU  - Manna A
AD  - Microbiology, Infectious Diseases & Beliaghata General Hospital (IDBGH), Kolkata, 
      IND.
FAU - Kundu, Asis Kumar
AU  - Kundu AK
AD  - Model Anti-Rabies Clinic, Infectious Diseases & Beliaghata General Hospital 
      (IDBGH), Kolkata, IND.
FAU - Sharma Sarkar, Biswanath
AU  - Sharma Sarkar B
AD  - General Medicine, Infectious Diseases & Beliaghata General Hospital (IDBGH), 
      Kolkata, IND.
FAU - Maji, Baisakhi
AU  - Maji B
AD  - Community Medicine, Infectious Diseases & Beliaghata General Hospital (IDBGH), 
      Kolkata, IND.
FAU - Dutta, Trayambak
AU  - Dutta T
AD  - Medical Affairs, Zydus Lifesciences, Ahmedabad, IND.
FAU - Mahajan, Manish
AU  - Mahajan M
AD  - Medical Affairs, Zydus Lifesciences, Ahmedabad, IND.
LA  - eng
PT  - Journal Article
DEP - 20240112
PL  - United States
TA  - Cureus
JT  - Cureus
JID - 101596737
PMC - PMC10859109
OTO - NOTNLM
OT  - adverse events
OT  - post-exposure prophylaxis
OT  - rabies
OT  - safety assessment
OT  - twinrabtm
COIS- The authors have declared financial relationships, which are detailed in the next 
      section.
EDAT- 2024/02/12 15:42
MHDA- 2024/02/12 15:43
PMCR- 2024/01/12
CRDT- 2024/02/12 04:24
PHST- 2024/01/04 00:00 [accepted]
PHST- 2024/02/12 15:43 [medline]
PHST- 2024/02/12 15:42 [pubmed]
PHST- 2024/02/12 04:24 [entrez]
PHST- 2024/01/12 00:00 [pmc-release]
AID - 10.7759/cureus.52163 [doi]
PST - epublish
SO  - Cureus. 2024 Jan 12;16(1):e52163. doi: 10.7759/cureus.52163. eCollection 2024 
      Jan.