EPCLUSA is indicated for the treatment of adults with chronic hepatitis C virus (HCV) GT 1-6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis.

TREAT WITH PROVEN SAFETY.

EPCLUSA DEMONSTRATED
A FAVORABLE
SAFETY PROFILE1

EPCLUSA
DEMONSTRATED
A FAVORABLE
SAFETY PROFILE1

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

  • Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with EPCLUSA due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.
  • Risk of Reduced Therapeutic Effect Due to Concomitant Use of EPCLUSA with P-gp Inducers and/or Moderate to Potent Inducers of CYP2B6, CYP2C8 or CYP3A4: Rifampin, St. John’s wort, and carbamazepine are not recommended for use with EPCLUSA as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations.
  • Adverse reactions reported in ≥5% of subjects in ASTRAL-1, -2, -3: headache (22%), fatigue (15%), nausea (9%), asthenia (5%), and insomnia (5%). Irritability was also observed in ≥5% of subjects treated with EPCLUSA in ASTRAL-31
  • Adverse reactions reported in ≥10% of HCV/HIV-1–coinfected subjects in ASTRAL-5: fatigue (22%) and headache (10%). The safety profile in HCV/HIV-1–coinfected subjects was similar to that observed in HCV mono-infected subjects1
  • Adverse reactions reported in ≥5% of subjects in HCV-TARGET (n=407): headache (14%), fatigue (14%), nausea (7%), and influenza-like illness (6%)2
  • Adverse reactions reported in ≥5% of subjects in the Puglia, Italy study (n=909): headache (49%), fatigue (34%), and irritability (19%)3
  • P-gp inducers and/or moderate to potent CYP inducers (eg, rifampin, St. John’s wort, carbamazepine): may decrease concentrations of sofosbuvir and/or velpatasvir. Use of EPCLUSA with P-gp inducers and/or moderate to potent CYP inducers is not recommended
  • Frequent monitoring of international normalized ratio (INR) values is recommended in patients receiving warfarin
  • Consult the full prescribing information prior to use for potential drug interactions

LOW RATES OF DISCONTINUATIONS DUE TO AEs IN CLINICAL TRIALS1

Discontinuations due to AEs

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GT = genotype

GT = genotype

REFERENCES:
  1. EPCLUSA US full Prescribing Information. Gilead Sciences, Inc. Foster City, CA. November 2017.
  2. Landis CS, Sulkowski MS, Reau N, et al. Safety and efficacy of velpatasvir and sofosbuvir-based regimens for the treatment of HCV genotype 1-6: results of the HCV-TARGET study. Poster presented at: AASLD The Liver Meeting®, October 20-24, 2017: Washington, DC.
  3. Mangia A, Piazzolla V, Losappio R, et al. High SVR rates in patients with and without cirrhosis treated in real life with sofosbuvir/velpatasvir (SOF/VEL) combination for 12 weeks without ribavirin (RBV). Poster presented at The International Liver Congress 2018, European Association for the Study of the Liver (EASL), 11-15 April 2018: Paris, France.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

Contraindications

  • If EPCLUSA is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, in particular pregnancy avoidance, and adverse reactions to RBV also apply. Refer to RBV prescribing information.

Warnings and Precautions

  • Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with EPCLUSA due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.
  • Risk of Reduced Therapeutic Effect Due to Concomitant Use of EPCLUSA with P-gp Inducers and/or Moderate to Potent Inducers of CYP2B6, CYP2C8 or CYP3A4: Rifampin, St. John’s wort, and carbamazepine are not recommended for use with EPCLUSA as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations.

Adverse Reactions

  • The most common adverse reactions (10%, all grades) with EPCLUSA were headache and fatigue; and when used with RBV in decompensated cirrhotics were fatigue, anemia, nausea, headache, insomnia, and diarrhea.

Drug Interactions

  • Coadministration of EPCLUSA is not recommended with topotecan due to increased concentrations of topotecan.
  • Coadministration of EPCLUSA is not recommended with proton-pump inhibitors, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir due to decreased concentrations of sofosbuvir and/or velpatasvir.

Consult the full Prescribing Information for EPCLUSA for more information on potentially significant drug interactions, including clinical comments.

Please see full Prescribing Information for EPCLUSA, including BOXED WARNING.

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