Antiviral Activity, Safety, and Tolerability of Multiple Ascending Doses of Elbasvir or Grazoprevir in Participants Infected With Hepatitis C Virus Genotype-1 or -3

Yeh, Wendy W.; Fraser, Iain P.; Jumes, Patricia; Petry, Amelia S.; Lepeleire, Inge De; Robberechts, Martine; Reitmann, Christina; Dyck, Kristien Van; Huang, Xiaobi; Guo, Zifang; Panebianco, Deborah; Nachbar, Robert B.; O’Mara, Edward; Wagner, John A.; Butterton, Joan R.; Dutko, Frank J.; Моисеев, В С; Kobalava, Z.; Hüser, Andreas; Visan, Sorin; Schwabe, Christian; Gane, Edward; Popa, Serghei; Ghicavii, N.; Uhle, Markus; Wagner, Frank

doi:10.1016/j.clinthera.2018.03.002

Cited by 5 publications

(1 citation statement)

References 33 publications

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“…For genotypes 1a and 1b the mean maximum HCV-RNA reduction was > 4.0 log 10 IU/mL at a dose of EBR 50 mg. For genotype 3 the doses of EBR 50 and 100 mg had a mean maximum HCV-RNA reduction of > 3.0 log 10 IU/mL. These data suggest a dose of 50 mg of EBR is sufficient [72].…”

Section: Efficacy and Toxicitymentioning

confidence: 99%

Viral Hepatitis C Therapy: Pharmacokinetic and Pharmacodynamic Considerations: A 2019 Update

et al. 2019

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It has been estimated by the World Health Organization (WHO) that over 71 million people were infected with the hepatitis C virus (HCV) in 2015. Since then, a number of highly effective direct-acting antiviral (DAA) regimens have been licensed for the treatment of chronic HCV infection: sofosbuvir/daclatasvir, sofosbuvir/ledipasvir, elbasvir/grazoprevir, sofosbuvir/ velpatasvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir. With these treatment regimens, almost all chronic HCV-infected patients, even including prior DAA failures, can be treated effectively and safely. It is therefore likely that further development of DAAs will be limited. In this descriptive review we provide an overview of the clinical pharmacokinetic characteristics of currently available DAAs by describing their absorption, distribution, metabolism, and excretion. Potential drug-drug interactions with the DAAs are briefly discussed. Furthermore, we summarize what is known about the pharmacodynamics of the DAAs in terms of efficacy and safety. We briefly discuss the relationship between the pharmacokinetics of the DAAs and efficacy or toxicity in special populations, such as hard to cure patients and patients with liver cirrhosis, liver transplantation, renal impairment, hepatitis B virus or HIV co-infection, bleeding disorders, and children. The aim of this overview is to educate/update prescribers and pharmacists so that they are able to safely and effectively treat HCV-infected patients even in the presence of underlying co-infections or co-morbidities.

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Section: Efficacy and Toxicitymentioning

confidence: 99%