Author: Duval, Xavier ; Sibiude, Jeanne ; Tubiana, Sarah ; Zureik, Mahmoud ; Weill, Alain ; Picone, Olivier ; Dray‐Spira, Rosemary ; Herlemont, Philippe ; Drouin, Jérôme

AimsTo describe the trends in anti‐infective use during pregnancy between 2010 and 2019 and determine whether they were prescribed according to drug foetal safety international classification systems.MethodsWe conducted a population‐based, nationwide study using the French national health data system including all pregnancies ended between 2010 and 2019. Anti‐infective agents were considered according to their pharmacological group and potential harmful risk using the Australian and Swedish classification systems. Prevalence rate was estimated annually and by trimester. Average annual percent change (AAPC) and 95% confidence intervals (CIs) were calculated using Joinpoint regression.ResultsAmong 7 571 035 pregnancies, 3 027 031 (40.0%) received ≥1 antibacterial. This proportion decreased significantly from 41.5% in 2010 to 36.1% in 2019 (AAPC = −1.7%, [95%CI, −2.5 to −1.0%]). Conversely, use of antiviral agents increased during the 10‐year study period for anti‐herpes simplex virus agents (AAPC = 4.4%, [3.7–5.2%]), influenza agents (AAPC = 25.4%, [6.2–48.1%]) and for HIV‐antiretroviral agents (AAPC = 1.3%, [0.6–2.0%]). Use of influenza vaccine increased from 0.2% in 2010 to 4.2% in 2019 (AAPC = 49.7%, [39.3–60.9%]). Among all pregnancies, 0.9% had been exposed to a potentially harmful anti‐infective agent increasing from 0.7% in 2010 to 1.2% in 2019 (AAPC = 6.4%, [4.4–8.5%]).ConclusionBased on >7 million pregnancies identified from French nationwide data, this study showed that antibacterials are frequently prescribed during pregnancy although their use has decreased over the past 10 years. Our results suggest that anti‐infective agents are generally prescribed in accordance with recommendations, although with a potential for improvement in influenza vaccination.

01 Dec 2022·Clinical Pharmacology in Drug Development

Pharmacokinetics and Safety Study of HN0037, a Novel Anti‐Human Herpes Simplex Virus Inhibitor, in Healthy Volunteers

Article

Author: Gao, Hong ; Qin, Meng ; Wang, Ying ; Zhou, Yi ; Fan, Yingzhe ; Hou, Jie ; Zhou, Xin ; Hill, George ; Wang, Lu ; Qin, Donghui ; Di, Yujing

AbstractHN0037 is a helicase‐primase inhibitor developed to treat herpes simplex virus (HSV) infection. This study evaluated the safety, tolerability, and pharmacokinetics of HN0037, following oral administration in healthy volunteers. This double‐blind, placebo‐controlled, phase 1 study comprised two parts. In part 1, a single escalating dose of 10, 30, 60, 120, 200, 300, and 400 mg was assessed, and the food effect was evaluated in the 200‐mg cohort. In part 2, a multiple dose evaluation involving 30 and 100 mg once a day was conducted for 14 days. Following single oral doses, the systemic exposure of HN0037 increased in a proportional manner over the lower dose range (10–120 mg) and in a subproportional manner over the higher dose range (200–400 mg). Following multiple oral doses, significant drug accumulation of systemic exposure was found at steady state, and the half‐life ranged 50.4‐61.0 h. The food effect study results indicated that a high‐fat meal had a marginal impact on HN0037's pharmacokinetics. No differences were observed in the incidence of adverse events between HN0037 and placebo groups in either study. These results demonstrate that HN0037 is safe and well‐tolerated, supporting further clinical development.

26 Jan 2017·Zeitschrift für Naturforschung CQ4 · BIOLOGY

Discovery and preliminary structure-activity relationship of the marine natural product manzamines as herpes simplex virus type-1 inhibitors

Q4 · BIOLOGY

Article

Author: Hsia, Shao-chung V. ; Sayed, Khalid A. El ; Palem, Jayavardhana R. ; Mudit, Mudit

AbstractHerpes simplex virus type-1 (HSV-1) is a member of alpha-herpesviridae family and is known to cause contagious human infections. The marine habitat is a rich source of structurally unique bioactive secondary metabolites. A small library of marine natural product classes1–10has been screened to discover a new hit entity active against HSV-1. Manzamine A showed potent activity against HSV-1 via targeting the viral gene ICP0. Manzamine A is a β-carboline alkaloid isolated from the Indo-Pacific spongeAcanthostrongylophoraspecies. Currently, acyclovir is the drug of choice for HSV-1 infections. Compared with 50 µM acyclovir, manzamine A at 1 µM concentration produced potent repressive effects on viral replication and release of infectious viruses in SIRC cells in recent studies. The potent anti-HSV-1 activity of manzamine A prompted a preliminary structure-activity relationship study by testing targeted manzamines. These included 8-hydroxymanzamine A (11), to test the effect of the C-8 hydroxy substitution at the β-carboline moiety; manzamine E (12), to assess the importance of substitution at the azacyclooctane ring; and ircinal A (13), to determine whether the β-carboline ring is required for the activity. Manzamine A was chemically transformed to its salt forms, manzamine A monohydrochloride (14) and manzamine A monotartrate (15), to test whether improving water solubility and hydrophilicity will positively affect the activity. Compounds were tested for activity against HSV-1 using fluorescent microscopy and plaque assay. The results showed the reduced anti-HSV-1 activity of11, suggesting that C-8 hydroxy substitution might adversely affect the activity. Similarly, manzamines12and13showed no activity against HSV-1, indicating the preference of the unsubstituted azacylcooctane and β-carboline rings to the activity. Anti-HSV-1 activity was significantly improved for the manzamine A salts14and15, suggesting that improving the overall water solubility as salt forms can significantly enhance the activity. Manzamines have significant potential for future development as anti-HSV-1 entity.

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Indication	Highest Phase	Country/Location	Organization	Date
Herpes Simplex	Preclinical	US	Cytogenix, Inc.	-

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