957 Pharmacokinetics, Safety and Tolerability of the HCV Polymerase Inhibitor Abt-333 Following Multiple Ascending Doses and Effect of Co-Administration of Ketoconazole in Healthy Subjects

Menon, R.; Cohen, Darrel P.; Nada, Aly; Chiu, Yi-Lin; Podsadecki, Thomas; Awni, Walid M.; Bernstein, Barry; Klein, Colin

doi:10.1016/s0168-8278(09)60959-4

Cited by 5 publications

(4 citation statements)

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“…The pharmacokinetics of ombitasvir, paritaprevir, ritonavir, and dasabuvir have been studied in healthy volunteers as well as HCV genotype-1-infected patients. 24,28-33 Table 1 summarizes the PK parameters of all 4 drugs. Ombitasvir, paritaprevir, ritonavir, and dasabuvir were well absorbed after oral administration.…”

Section: Pharmacokineticsmentioning

confidence: 99%

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Tablets for Hepatitis C Virus Genotype 1 Infection

2015

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Section: Pharmacokineticsmentioning

confidence: 99%

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Tablets for Hepatitis C Virus Genotype 1 Infection

2015

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“…For this reason, use of dasabuvir is limited to genotype 1 patients and it also must be used in combination with other agents. However, in genotype 1a and 1b infection, it exhibits highly potent and selective activity [11] and is safe and well tolerated in single and multiple ascending doses in healthy volunteers [14,15].…”

Section: Dasabuvirmentioning

confidence: 99%

Dasabuvir: a new direct antiviral agent for the treatment of hepatitis C

Trivella

Gutiérrez

Martin³

2015

Expert Opinion on Pharmacotherapy

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Dasabuvir-containing regimens achieve high rates of sustained virologic response in HCV genotype 1a and 1b-infected patients when combined with other DAAs, namely paritaprevir (ABT-450), ritonavir and ombitasvir (ABT-267). In the populations studied, dasabuvir seems to be well tolerated and safe. The major limitations of this novel drug are its genotype-restricted activity, the necessity to include ribavirin for HCV genotype 1a and the emergence of resistance if not combined with other DDAs.

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“…1 Protein binding is greater than 99.5%, and volume of distribution is 396 L. 1 Multiple oral doses of dasabuvir at 200 or 400 mg twice daily did not produce significant accumulation after 10 days. 19 Primary metabolism is by CYP2C8 and, to a lesser extent, CYP3A. Following single oral doses, approximately 94.4% of radioactivity was recovered in feces, with 26% of radioactivity from unchanged dasabuvir.…”

Section: Pharmacokineticsmentioning

confidence: 99%

“…For a summary of clinically manageable interactions with recommendations for management, see Table 3. . 1,19,22…”

Section: Drug Interactionsmentioning

confidence: 99%

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir

et al. 2015

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Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line. Monographs can be customized to meet the needs of a facility. A drug class review is now published monthly with The Formulary Monograph Service. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, call The Formulary at 800-322-4349. The May 2015 monograph topics are palbociclib, lenvatinib, nivolumab, ferric pyrophosphate citrate solution, and secukinumab. The Safety MUE is on non-opioid injectable pain or fever medications.

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957 Pharmacokinetics, Safety and Tolerability of the HCV Polymerase Inhibitor Abt-333 Following Multiple Ascending Doses and Effect of Co-Administration of Ketoconazole in Healthy Subjects

Cited by 5 publications

References 0 publications

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Tablets for Hepatitis C Virus Genotype 1 Infection

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Tablets for Hepatitis C Virus Genotype 1 Infection

Dasabuvir: a new direct antiviral agent for the treatment of hepatitis C

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir

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