Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation

Search Page

Filters

My NCBI Filters

Results by year

Table representation of search results timeline featuring number of search results per year.

Year Number of Results
2017 1
2018 5
2019 2
2020 1
2022 1
2024 0

Text availability

Article attribute

Article type

Publication date

Search Results

9 results

Results by year

Filters applied: . Clear all
Page 1
Short-Duration AL-335, Odalasvir, With or Without Simeprevir, in Patients With HCV GT1 or 3 Infection Without Cirrhosis.
Gane EJ, Stedman CA, Schwabe C, Vijgen L, Chanda S, Kakuda TN, Fry J, Blatt LM, McClure MW. Gane EJ, et al. Hepatology. 2018 Dec;68(6):2145-2157. doi: 10.1002/hep.30126. Epub 2018 Nov 19. Hepatology. 2018. PMID: 30070722 Clinical Trial.
Multiple 6-12-week oral regimens of 400-800 mg once daily (QD) AL-335 + 50 mg QD/every other day odalasvir 75-150 mg QD simeprevir were evaluated in treatment-naive, HCV genotype (GT)1/3-infected patients without cirrhosis. ...Pharmacokinetic characteristics of the …
Multiple 6-12-week oral regimens of 400-800 mg once daily (QD) AL-335 + 50 mg QD/every other day odalasvir 75-150 mg QD simepr …
JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-Infected Patients Without Cirrhosis: OMEGA-1.
Zeuzem S, Bourgeois S, Greenbloom S, Buti M, Aghemo A, Lampertico P, Janczewska E, Lim SG, Moreno C, Buggisch P, Tam E, Corbett C, Willems W, Vijgen L, Fevery B, Ouwerkerk-Mahadevan S, Ackaert O, Beumont M, Kalmeijer R, Sinha R, Biermer M; OMEGA-1 study team. Zeuzem S, et al. Hepatology. 2019 Jun;69(6):2349-2363. doi: 10.1002/hep.30527. Epub 2019 Mar 14. Hepatology. 2019. PMID: 30693573 Clinical Trial.
The combination of three direct-acting antiviral agents (AL-335, odalasvir, and simeprevir: JNJ-4178 regimen) for 6 or 8 weeks demonstrated good efficacy and safety in a phase IIa study in chronic hepatitis C virus (HCV) genotype (GT)-1-infected patients without cir …
The combination of three direct-acting antiviral agents (AL-335, odalasvir, and simeprevir: JNJ-4178 regimen) for 6 or 8 weeks …
Safety, tolerability, and pharmacokinetics of AL-335 in healthy volunteers and hepatitis C virus-infected subjects.
McClure MW, Berliba E, Tsertsvadze T, Streinu-Cercel A, Vijgen L, Astruc B, Patat A, Westland C, Chanda S, Zhang Q, Kakuda TN, Vuong J, Khorlin N, Beigelman L, Blatt LM, Fry J. McClure MW, et al. PLoS One. 2018 Oct 16;13(10):e0204974. doi: 10.1371/journal.pone.0204974. eCollection 2018. PLoS One. 2018. PMID: 30325939 Free PMC article. Clinical Trial.
METHODS: This three-part randomized, double-blind study evaluated the safety and pharmacokinetics of single and multiple ascending oral doses of AL-335. Healthy volunteers (HVs) received single doses of AL-335 (100-1,200 mg) or placebo in a fasted or f …
METHODS: This three-part randomized, double-blind study evaluated the safety and pharmacokinetics of single and multiple ascending oral dose …
JNJ-4178 (adafosbuvir, odalasvir, and simeprevir) in Japanese patients with chronic hepatitis C virus genotype 1 or 2 infection with or without compensated cirrhosis: the Phase IIa OMEGA-3 study.
Takehara T, Chayama K, Kurosaki M, Yatsuhashi H, Tanaka Y, Hiramatsu N, Sakamoto N, Asahina Y, Nozaki A, Nakano T, Hagiwara Y, Shimizu H, Yoshida H, Huang Y, Biermer M, Vijgen L, Hayashi N. Takehara T, et al. J Gastroenterol. 2020 Jun;55(6):640-652. doi: 10.1007/s00535-020-01672-0. Epub 2020 Feb 17. J Gastroenterol. 2020. PMID: 32065330 Free PMC article. Clinical Trial.
BACKGROUND: The efficacy, safety, and pharmacokinetics of the combination of three direct-acting antiviral (DAA) agents (adafosbuvir [also known as AL-335], odalasvir, and simeprevir) were investigated in DAA treatment-naive Japanese patients with genotype (G …
BACKGROUND: The efficacy, safety, and pharmacokinetics of the combination of three direct-acting antiviral (DAA) agents (adafosbuvir …
Population Pharmacokinetics of AL-335 and Its Two Main Metabolites (ALS-022399, ALS-022227) in Monotherapy and in Combination with Odalasvir and/or Simeprevir.
Valade E, Kakuda TN, McClure MW, Westland C, Valenzuela B, Ouwerkerk-Mahadevan S, Perez-Ruixo JJ, Ackaert O. Valade E, et al. AAPS J. 2018 Oct 24;21(1):1. doi: 10.1208/s12248-018-0272-z. AAPS J. 2018. PMID: 30377854 Clinical Trial.
AL-335, ALS-022399, and ALS-022227 plasma concentrations from subjects receiving 800 mg of AL-335 orally once daily (qd) as monotherapy or in combination were pooled and analyzed using a nonlinear mixed effect modeling approach. The typical values (bet …
AL-335, ALS-022399, and ALS-022227 plasma concentrations from subjects receiving 800 mg of AL-335 orally once da …
Pharmacokinetics, safety, and tolerability of the 2- and 3-direct-acting antiviral combination of AL-335, odalasvir, and simeprevir in healthy subjects.
Kakuda TN, McClure MW, Westland C, Vuong J, Homery MC, Poizat G, Viguerie L, Denot C, Patat A, Zhang Q, Hui J, Apelian D, Smith DB, Chanda SM, Fry J. Kakuda TN, et al. Pharmacol Res Perspect. 2018 Apr 30;6(3):e00395. doi: 10.1002/prp2.395. eCollection 2018 Jun. Pharmacol Res Perspect. 2018. PMID: 29736243 Free PMC article. Clinical Trial.
This Phase I, open-label, two-group, fixed-sequence study evaluated the pharmacokinetics and safety of AL-335, odalasvir, and simeprevir in healthy subjects. Group 1 (n = 16) received AL-335 800 mg once daily (QD) (days 1-3, 11-13, and 21-23), simeprev …
This Phase I, open-label, two-group, fixed-sequence study evaluated the pharmacokinetics and safety of AL-335, odalasvir, and …
4'-Modified Nucleosides for Antiviral Drug Discovery: Achievements and Perspectives.
Chang J. Chang J. Acc Chem Res. 2022 Feb 15;55(4):565-578. doi: 10.1021/acs.accounts.1c00697. Epub 2022 Jan 25. Acc Chem Res. 2022. PMID: 35077644
Currently, seven 4'-modified nucleoside drug candidates such as azvudine (also known as FNC), islatravir, censavudine, balapiravir, lumicitabine, AL-335, and 4-azidothymidine have progressed into clinical stages for treating viral infections. ...
Currently, seven 4'-modified nucleoside drug candidates such as azvudine (also known as FNC), islatravir, censavudine, balapiravir, lumicita …
Synthesis and Anti-HCV Activities of 4'-Fluoro-2'-Substituted Uridine Triphosphates and Nucleotide Prodrugs: Discovery of 4'-Fluoro-2'- C-methyluridine 5'-Phosphoramidate Prodrug (AL-335) for the Treatment of Hepatitis C Infection.
Wang G, Dyatkina N, Prhavc M, Williams C, Serebryany V, Hu Y, Huang Y, Wan J, Wu X, Deval J, Fung A, Jin Z, Tan H, Shaw K, Kang H, Zhang Q, Tam Y, Stoycheva A, Jekle A, Smith DB, Beigelman L. Wang G, et al. J Med Chem. 2019 May 9;62(9):4555-4570. doi: 10.1021/acs.jmedchem.9b00143. Epub 2019 Apr 19. J Med Chem. 2019. PMID: 30951311
In an HCV subgenomic replicon assay, the phosphoramidate prodrugs of these uridine analogues demonstrated a very potent activity with EC(50) values as low as 20 nM. A lead compound AL-335 (53) demonstrated high levels of the nucleoside triphosphate in vitro in prima …
In an HCV subgenomic replicon assay, the phosphoramidate prodrugs of these uridine analogues demonstrated a very potent activity with EC(50) …