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 POWER.

EPCLUSA DELIVERED HIGH
CURE RATES ACROSS
EVERY GENOTYPE AND
FIBROSIS SCORE1,2

EPCLUSA DELIVERED
HIGH CURE RATES
ACROSS EVERY
GENOTYPE AND
FIBROSIS SCORE1,2

EPCLUSA
DELIVERED
HIGH CURE
RATES ACROSS
EVERY GENOTYPE
AND FIBROSIS SCORE1,2

HIGH CURE RATES
IN GT 1-61,a

Study identifying cure rates in hepatitis C

aSVR12 is defined as undetectable HCV RNA at 12 weeks after the end of treatment.1-4 Achieving SVR is considered a virologic cure.5

% SVR in subjects treated with EPCLUSA for 12 weeks1,a
Patients treated for 12 weeks

PANFIBROTIC EFFICACY IN ALL GENOTYPES,
INCLUDING THE MOST COMMON GT 11,2,b

Percentage overall HCV treatment cure rate by fibrosis score

Completer analysis included patients treated with 12 weeks of EPCLUSA from ASTRAL-1, -2, -3 and POLARIS-2, -3 studies.2,b

CC = compensated cirrhosis

TREAT WITH CONFIDENCE.

REAL-WORLD STUDIES REFLECT CURE RATES SEEN IN CLINICAL TRIALS3,4

Overall real-world study cure rate for HCV patients
Overall real-world study cure rate for HCV genotypes 1-4

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bCompleter efficacy analysis includes all patients who were randomized, completed assigned study treatment, and had HCV RNA data observed at post-treatment Week 12 or thereafter.

GT = genotype, HIV = human immunodeficiency virus, ITT = intent-to-treat, PP = per-protocol analysis is a comparison of treatment groups that includes only those patients who completed the treatment originally allocated, SVR = sustained virologic response

GT = genotype, HIV = human immunodeficiency virus, ITT = intent-to-treat, PP = per-protocol analysis is a comparison of treatment groups that includes only those patients who completed the treatment originally allocated, SVR = sustained virologic response

REFERENCES:
  1. EPCLUSA US full Prescribing Information. Gilead Sciences, Inc. Foster City, CA. November 2017.
  2. Lawitz E, Bourlière M, Han L, et al. Treatment with SOF/VEL or SOF/VEL/VOX is well tolerated and results in high SVR12 in genotype 1–6 HCV–infected patients with minimal fibrosis: a retrospective analysis of the ASTRAL and POLARIS clinical studies. Poster presented at: International Liver Congress™, 19-23 April 2017: Amsterdam, the Netherlands.
  3. 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.
  4. 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.
  5. US Department of Health and Human Services, Center for Drug Evaluation and Research. Guidance for industry. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment. November 2017.

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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