Conţinutul numărului revistei |
Articolul precedent |
Articolul urmator |
582 0 |
SM ISO690:2012 MARCELLIN, Patrick, POPA, Sergiu, BERLIBA, Elina, BOYER, Nathalie, STREINU-CERCEL, Anca, TONG, Myron, KAUFFMAN, Robert, KOZIEL, Margaret, CHANDA, Sushmita, ZHANG, Qingling, WESTLAND, Christopher E., BEIGELMAN, Leonid N., BLATT, Lawrence Mitchell, FRY, John. ALS-2200, a novel once-daily nucleotide HCV polymerase inhibitor, demonstrates potent antiviral activity in treatmentnaıve GT1 chronic hepatitis C patients. In: Hepatology International, 2013, nr. S1(7), p. 342. ISSN 1936-0533. |
EXPORT metadate: Google Scholar Crossref CERIF DataCite Dublin Core |
Hepatology International | |
Numărul S1(7) / 2013 / ISSN 1936-0533 /ISSNe 1936-0541 | |
|
|
Pag. 342-342 | |
Teza |
|
Background: A Phase I randomized, double-blind, placebo (PLB) controlled study was conducted to assess safety, pharmacokinetics, and antiviral activity of ALS-2200 (a novel nucleotide analog HCV polymerase inhibitor) in healthy volunteers (HV) and treatment-naı¨ve patients with GT1 chronic hepatitis C (CHC). Methods: HV received doses up to 800 mg. CHC patients received multiple doses (ALS–2200 15 mg, 50 mg, 100 mg, 200 mg QD) or PLB (8:2) for 7 days (n = 10 per cohort). An additional cohort received ALS-2200 200 mg with ribavirin (1000 mg or 1200 mg/day). Results: 48 HV and 50 GT1 CHC patients were enrolled of which 35 were male and 48 GT-1b. Plasma PK of ALS-2200 and its metabolites confirmed rapid uptake in the liver. ALS-2200 was well tolerated in HV up to 800 mg and with multiple dosing in GT1 CHC patients. AEs reported in CHC patients receiving ALS-2200 were of mild or moderate severity; all AEs resolved without intervention. Most common AEs: headache (4/50),rash with pruritus (3/50) (2 in RBV arm). No SAEs or discontinuations due to AEs were reported. Median reduction in HCV RNA concentrations following 7-days treatment are shown below. No virologic breakthrough occurred during treatment. Data from 2 additional cohorts, patients with cirrhosis and GT2-6 CHC, will be included in the presentation (Table 1). Conclusions: ALS-2200 has the potential to be a component of oncedaily, all-oral, interferon–free CHC treatment regimens. |
Google Scholar Export
<meta name="citation_title" content="ALS-2200, a novel once-daily nucleotide HCV polymerase inhibitor, demonstrates potent antiviral activity in treatmentnaıve GT1 chronic hepatitis C patients"> <meta name="citation_author" content="Marcellin Patrick"> <meta name="citation_author" content="Popa Sergiu"> <meta name="citation_author" content="Berliba Elina"> <meta name="citation_author" content="Boyer Nathalie"> <meta name="citation_author" content="Streinu-Cercel Anca"> <meta name="citation_author" content="Tong Myron"> <meta name="citation_author" content="Kauffman Robert"> <meta name="citation_author" content="Koziel Margaret"> <meta name="citation_author" content="Chanda Sushmita"> <meta name="citation_author" content="Zhang Qingling"> <meta name="citation_author" content="Westland Christopher E."> <meta name="citation_author" content="Beigelman Leonid N."> <meta name="citation_author" content="Blatt Lawrence Mitchell"> <meta name="citation_author" content="Fry John"> <meta name="citation_publication_date" content="2013/06/08"> <meta name="citation_journal_title" content="Hepatology International"> <meta name="citation_volume" content="7"> <meta name="citation_issue" content="S1"> <meta name="citation_firstpage" content="342"> <meta name="citation_lastpage" content="342"> <meta name="citation_pdf_url" content="https://ibn.idsi.md/sites/default/files/imag_file/342_0.pdf">