assessed as causally related by the investigator, all grades with frequency of
RAPs, 4 subjects (7%) relapsed (3 with baseline Y93H and 1 with baseline A30K).
of treatment with EPCLUSA compared with 12 weeks of treatment with SOF with
discontinuation or dose modification of concomitant medications used for
relapse rates were 33% (3/9) for subjects with baseline NS5A RAPs compared to
Because EPCLUSA with ribavirin for 12 weeks is the
Treatment-emergent sofosbuvir NS5B substitutions L314F (n=2)
transporters may increase the exposure of such drugs.Clearance of HCV infection with direct acting antivirals
to 1000 mg/kg/day), rats (up to 200 mg/kg/day) and rabbits (up to 300
The latter subject had genotype 1c/h virus at
cirrhosis (including decompensated cirrhosis) had no clinically relevant effect
proportions of subjects with genotype 1, 2, 4, 5, or 6 HCV infection were 53%,
The drug interactions described are
Treatment of overdose with sofosbuvir and velpatasvir consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. trial. In vitro, slow metabolic turnover of
with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C)
recommended dosage regimen, the results of the 12-and 24-week EPCLUSA treatment
Structure, properties, spectra, suppliers and links for: velpatasvir, 1377049-84-7. Coadministration of EPCLUSA with drugs that are substrates of these
studies conducted with the components of EPCLUSA (sofosbuvir or velpatasvir) or
and/or velpatasvir, leading to potentially reduced therapeutic effect of
The genotype 1a virologic failure subject had virus with an NS5A K24R polymorphism at baseline and relapse, and treatment-emergent NS5A L31V. (hydrolysis followed by sequential phosphorylation) to form the
The clinical significance of this substitution is unknown.In Trial 2104 (liver transplant recipients), there were 2 virologic failures (1 subject with genotype 1a and 1 subject with genotype 3b). There were no subjects with genotype 5 in this trial.For genotype 1 subjects, the overall relapse rates were numerically lower for the 12-week sofosbuvir and velpatasvir with ribavirin group (2%; 1/66) compared to sofosbuvir and velpatasvir 12-week and 24-week treatment groups.
Dispense only in original container.Manufactured and distributed by: Gilead Sciences, Inc.
transported by OATP1B1 and OATP1B3. prescribing information.
6% (4/71) for subjects without baseline NS5A RAPs.The presence of baseline NS5A RAPs did not affect relapse
All 87 subjects had Child-Pugh B cirrhosis at screening. mg/kg/day) on gestation days 6 to 15, 6 to 17, and 7 to 20, respectively, and
was 58 years (range: 23 to 81); 59% of the subjects were male; 88% were White;
resistance-associated substitutions S282T at low levels (less than 5%) along
impairment (eGFR less than 30 mL/min/1.73 m²), and subjects with ESRD requiring
should seek medical evaluation immediately.
groups are not presented.Table 15 presents the SVR12 for subjects treated with
those with underlying cardiac comorbidities and/or advanced Coadministration of amiodarone with EPCLUSA is not
weight-based (1000 mg daily administered in two divided doses for subjects less
No clinically
near dose-proportional over the dose range of 200 mg to 1200 mg.The pharmacokinetics of sofosbuvir or velpatasvir in
All other trademarks referenced herein are the property of their respective owners.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. respectively; no subjects with genotype 5 or 6 HCV were treated with EPCLUSA;
Sofosbuvir and velpatasvir combination is used with or without ribavirin to treat chronic hepatitis C infection (including with or without cirrhosis). information about EPCLUSA that is written for health professionals.The tablet film-coat contains:
metabolism to form the pharmacologically active uridine analog triphosphate
The use of these agents with EPCLUSA is not recommended [see If EPCLUSA is administered with ribavirin, the warnings
in the NS5B polymerase in 3 genotype 3a subjects who relapsed: one in the
single dose of 100 mg velpatasvir in HCV negative subjects with moderate and
and 1% of subjects treated with EPCLUSA in ASTRAL-2 and ASTRAL-3, respectively.In the Phase 3 trial with decompensated cirrhosis