Benefit-risk assessment for brincidofovir for the treatment of smallpox: U.S. Food and Drug Administration's Evaluation

Chan-Tack, Kirk M.; Harrington, Patrick R.; Bensman, Timothy J.; Choi, Suyoung; Donaldson, Eric F.; O’Rear, Julian J.; McMillan, David; Myers, L. Peyton; Seaton, Mark J.; Ghantous, Hanan; Cao, Yu; Valappil, Thamban; Birnkrant, Debra; Struble, Kimberly

doi:10.1016/j.antiviral.2021.105182

Cited by 58 publications

(38 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…2 There are two authorized antiviral drugs for treatment of Monkeypox, Brincidofovir and Tecovrimat, but there is limited clinical experience on using either of these drugs in human outbreaks. 8,9 A recent small retrospective cohort of seven patients with Monkeypox in the United Kingdom, including four patients from the current outbreak, did not show any clear benefit of treatment with Brincidofovir in patients who received the drug. Tecovirimat appeared to reduce virus shedding and symptom duration in some patients.…”

mentioning

confidence: 87%

Neglecting emerging diseases – monkeypox is the latest price of a costly default

Titanji

2022

Med

View full text Add to dashboard Cite

mentioning

confidence: 87%

Neglecting emerging diseases – monkeypox is the latest price of a costly default

Titanji

2022

Med

View full text Add to dashboard Cite

“…The advantage of the drug is a broad-spectrum of in vitro confirmed activity against herpesviruses (VZV, HSV, CMV, EBV, and HHV6), polyomaviruses, adenoviruses, and papillomaviruses [ 88 , 89 ]. In June 2021, BCDV was approved by the FDA only to treat smallpox and was indicated for the treatment of adults and pediatric patients weighing at least 13 kg [ 90 ]. It was also a candidate for the CMV infection therapy.…”

Section: Antiviral Drugsmentioning

confidence: 99%

40 Years after the Registration of Acyclovir: Do We Need New Anti-Herpetic Drugs?

Majewska

Młynarczyk-Bonikowska

2022

IJMS

View full text Add to dashboard Cite

Herpes simplex virus types 1 and 2 HSV1 and 2, namely varicella-zoster VZV and cytomegalovirus CMV, are among the most common pathogens worldwide. They remain in the host body for life. The course of infection with these viruses is often asymptomatic or mild and self-limiting, but in immunocompromised patients, such as solid organ or bone marrow transplant recipients, the course can be very severe or even life-threatening. Unfortunately, in the latter group, the highest percentage of infections with strains resistant to routinely used drugs is observed. On the other hand, frequent recurrences of genital herpes can be a problem even in people with normal immunity. Genital herpes also increases the risk of acquiring sexually transmitted diseases, including HIV infection and, if present in pregnant women, poses a risk to the fetus and newborn. Even more frequently than herpes simplex, congenital infections can be caused by cytomegalovirus. We present the most important anti-herpesviral agents, the mechanisms of resistance to these drugs, and the associated mutations in the viral genome. Special emphasis was placed on newly introduced drugs such as maribavir and brincidofovir. We also briefly discuss the most promising substances in preclinical testing as well as immunotherapy options and vaccines currently in use and under investigation.

show abstract

“…In addition, both oral drugs have demonstrated efficacy against other orthopoxviruses (including monkeypox) in multiple animal models [ 62 – 64 ]. Tecovirimat and brincidofovir have been shown to be safe and well tolerated at the recommended human doses in human clinical safety trials [ 65 ]. Tecovirimat prevents the spread of the virus by inhibiting the function of the major envelope protein VP37, preventing the virus from leaving the infected cell.…”

Section: Drugs and Vaccinesmentioning

confidence: 99%

Monkeypox virus: past and present

2022

View full text Add to dashboard Cite

Background The objective of this paper is to analyze the current status of monkeypox worldwide. In the face of this public health threat, our purpose is to elucidate the clinical characteristics and epidemiology of monkeypox, the developmental progress of monkeypox-related drugs and the vaccines available. Data sources The literature review was performed in databases including PubMed, Science Direct and Google Scholar up to July 2022. Results Since May 2022, the World Health Organization has reported more than 45,000 confirmed cases from 92 nonendemic countries, including nine deaths. Although some women and children have been infected so far, most cases have occurred among men who have sex with other men, especially those with multiple sexual partners or anonymous sex. Conclusions Pediatric monkeypox infection has been associated with a higher likelihood of severe illness and mortality than in adults. Severe monkeypox illness in pediatrics often requires adjunctive antiviral therapy. It is crucial for all countries to establish sound monitoring and testing systems and be prepared with emergency preparedness.

show abstract

Benefit-risk assessment for brincidofovir for the treatment of smallpox: U.S. Food and Drug Administration's Evaluation

Cited by 58 publications

References 13 publications

Neglecting emerging diseases – monkeypox is the latest price of a costly default

Neglecting emerging diseases – monkeypox is the latest price of a costly default

40 Years after the Registration of Acyclovir: Do We Need New Anti-Herpetic Drugs?

Monkeypox virus: past and present

Contact Info

Product

Resources

About