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SOFOSBUVIR
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- The effect of sofosbuvir 400 and 1200 mg (three times the recommended dosage) on QTc interval was evaluated in a randomized, single-dose, placebo- and active-controlled (moxifloxacin 400 mg) four period crossover thorough QT trial in 59 healthy subjects. At a dosage three times the maximum recommended dosage, SOVALDI does not prolong QTc to any clinically relevant extent.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
11
24081
Other ADRs
78031
38303556
Odds Ratio = 0.225
Drug Property Information
ATC Code(s):
- J05AP08 - sofosbuvir
- J05AP -
- J05A - DIRECT ACTING ANTIVIRALS
- J05 - ANTIVIRALS FOR SYSTEMIC USE
- J - ANTIINFECTIVES FOR SYSTEMIC USE
- J05AP51 - sofosbuvir
- J05AP -
- J05A - DIRECT ACTING ANTIVIRALS
- J05 - ANTIVIRALS FOR SYSTEMIC USE
- J - ANTIINFECTIVES FOR SYSTEMIC USE
- J05AP55 - sofosbuvir
- J05AP -
- J05A - DIRECT ACTING ANTIVIRALS
- J05 - ANTIVIRALS FOR SYSTEMIC USE
- J - ANTIINFECTIVES FOR SYSTEMIC USE
- J05AP56 - sofosbuvir
- J05AP -
- J05A - DIRECT ACTING ANTIVIRALS
- J05 - ANTIVIRALS FOR SYSTEMIC USE
- J - ANTIINFECTIVES FOR SYSTEMIC USE
Active Ingredient:SOFOSBUVIR
Active Ingredient UNII:WJ6CA3ZU8B
Drugbank ID:DB08934
PubChem Compound:45375808
CTD ID:D000069474
PharmGKB:PA166122593
CAS Number:1190307-88-0
Dosage Form(s):pellet; tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
- 400.0 mg/day J05AP08
Chemical Structure: 
SMILE Code:
CC(C)OC(=O)[C@H](C)N[P@](=O)(OC[C@H]1O[C@@H](N2C=CC(=O)NC2=O)[C@](C)(F)[C@@H]1O)OC1=CC=CC=C1
CC(C)OC(=O)[C@H](C)N[P@](=O)(OC[C@H]1O[C@@H](N2C=CC(=O)NC2=O)[C@](C)(F)[C@@H]1O)OC1=CC=CC=C1
Reference
1: Comparative efficacy and safety of pharmacological interventions for the treatment of COVID-19: A systematic review and network meta-analysis.
[Kim Min Seo,An Min Ho,Kim Won Jun,Hwang Tae-Ho]PLoS Med,2020 Dec 30;17(12):e1003501. PMID: 33378357
2: Liver Fibrosis Is Associated With Corrected QT Prolongation During Ledipasvir/Sofosbuvir Treatment for Patients With Chronic Hepatitis C.
[Tahata Yuki,Sakamori Ryotaro,Urabe Ayako,Morishita Naoki,Yamada Ryoko,Yakushijin Takayuki,Hiramatsu Naoki,Doi Yoshinori,Kaneko Akira,Hagiwara Hideki,Yamada Yukinori,Hijioka Taizo,Inada Masami,Tamura Shinji,Imai Yasuharu,Furuta Kunimaro,Kodama Takahiro,Hikita Hayato,Tatsumi Tomohide,Takehara Tetsuo]Hepatol Commun,2018 Aug 6;2(8):884-892. PMID: 30094400
3: Interferon-free therapy with direct acting antivirals for HCV/HIV-1 co-infected Japanese patients with inherited bleeding disorders.
[Uemura Haruka,Tsukada Kunihisa,Mizushima Daisuke,Aoki Takahiro,Watanabe Koji,Kinai Ei,Teruya Katsuji,Gatanaga Hiroyuki,Kikuchi Yoshimi,Sugiyama Masaya,Mizokami Masashi,Oka Shinichi]PLoS One,2017 Oct 18;12(10):e0186255. PMID: 29045448
4: Outcome of Combination Therapy with Sofosbuvir and Ledipasvir for Chronic Type C Liver Disease.
[Hagiwara Satoru,Nishida Naoshi,Watanabe Tomohiro,Sakurai Toshiharu,Ida Hiroshi,Minami Yasunori,Takita Masahiro,Minami Tomohiro,Iwanishi Mina,Chishina Hirokazu,Ueshima Kazuomi,Komeda Yoriaki,Arizumi Tadaaki,Kudo Masatoshi]Oncology,2017;92 Suppl 1:3-9. PMID: 27974712
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