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Personality rights of THE WRIGHT BROTHERS are used with permission of The Wright Family Fund. Represented by GreenLight.

INDICATION

SOVALDI is indicated for the treatment of genotype 1, 2, 3 or 4 chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen.

Dosage and Administration

SOVALDI offers simple dosing for patients with HCV genotypes 1, 2, 3 or 41

Recommended Treatment Regimens and Duration

aSee peginterferon (Peg‑IFN) alfa prescribing information for dosage recommendation for patients with genotype 1 or 4 HCV.

bDosage of ribavirin is weight-based (<75 kg = 1000 mg and 75 kg = 1200 mg). The daily dosage of ribavirin is administered orally in two divided doses with food. Patients with renal impairment (CrCl 50 mL/min) require ribavirin dosage reduction; refer to ribavirin prescribing information.

  • The recommended dosage of SOVALDI is one 400 mg tablet taken once daily with or without food1
  • No response-guided therapy is required with SOVALDI1
  • SOVALDI in combination with ribavirin for 24 weeks can be considered as a therapeutic option for HCV patients with GT 1 infection who are ineligible to receive an interferon-based regimen. Treatment decision should be guided by an assessment of the potential benefits and risks for the individual patient1
  • In patients with hepatocellular carcinoma (HCC) awaiting liver transplantation, administer SOVALDI in combination with ribavirin for up to 48 weeks or until the time of liver transplantation, whichever occurs first, to prevent post-transplant HCV reinfection1
  • If the other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued1
  • No SOVALDI dosage adjustments are necessary based on advanced age, race, mild or moderate renal impairment (eGFR 30 mL/min/1.73 m2) or hepatic impairment (Child-Pugh Class A, B, or C). The safety and efficacy of SOVALDI have not been established in patients with severe renal impairment, end stage renal disease (ESRD) or decompensated cirrhosis1
  • If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dosage should be reduced or discontinued, if appropriate, until the adverse reaction abates or decreases in severity. Refer to the peginterferon alfa and ribavirin prescribing information for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dosage1
Reference
  1. SOVALDI US full Prescribing Information. Gilead Sciences, Inc. Foster City, CA. August 2015.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Contraindications to peginterferon alfa and ribavirin also apply to SOVALDI combination treatment. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.

GT 2 Patients

SOVALDI + RBV is the first all-oral, IFN-free regimen for HCV genotype 2 patients1

SOVALDI offers GT 2 patients simple dosing in an all-oral, IFN-free regimen1
Recommended Treatment Regimen and Duration for SOVALDI Combination Therapy in HCV GT 2 Patients1

aDosage of ribavirin is weight-based (<75 kg = 1000 mg and 75 kg = 1200 mg). The daily dosage of ribavirin is administered orally in two divided doses with food. Patients with renal impairment (CrCl 50 mL/min) require ribavirin dosage reduction; refer to ribavirin prescribing information.

  • The recommended dosage of SOVALDI is one 400 mg tablet taken once daily with or without food1
  • No response-guided therapy is required with SOVALDI1
  • If the other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued1
  • No SOVALDI dosage adjustments are necessary based on advanced age, race, mild or moderate renal impairment (eGFR 30 mL/min/1.73 m2) or hepatic impairment (Child-Pugh Class A, B, or C). The safety and efficacy of SOVALDI have not been established in patients with severe renal impairment, end stage renal disease (ESRD) or decompensated cirrhosis1
  • If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. Refer to the peginterferon alfa and ribavirin prescribing information for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dose

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone and Another HCV Direct Acting Antiviral (DAA): Amiodarone is not recommended for use with SOVALDI in combination with another DAA 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. 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 of SOVALDI Due to Use with P-gp Inducers: Rifampin and St. John's wort are not recommended for use with SOVALDI as they may significantly decrease sofosbuvir plasma concentrations.
  • Risk Associated with Combination Treatment: Because SOVALDI is used in combination with other antiviral drugs for the treatment of HCV infection, consult the Prescribing Information for these drugs.
  • Related Products Not Recommended: SOVALDI is not recommended for use with other products containing sofosbuvir.

SOVALDI + RBV is the first all-oral, IFN-free regimen for HCV genotype 2 patients1

In VALENCE, SOVALDI + RBV delivered high cure (SVR) rates in treatment‑naïve and treatment‑experienced GT 2 patients1,a
% SVR12 in GT 2 treatment‑naïve and treatment‑experienced subjects in VALENCE1

aSustained virologic response (SVR12) was the primary endpoint, which was defined as HCV RNA <25 IU/mL at 12 weeks after the end of treatment.1 Achieving SVR is considered a virologic cure.2

VALENCE: GT 2 or 3 treatment‑naïve and -experienced adult subjects1

A trial evaluating SOVALDI in combination with weight-based RBV for the treatment of genotype 2 or 3 HCV infection in treatment‑naïve subjects or subjects who did not achieve SVR with prior interferon-based treatment. The original trial design was a 4:1 randomization to SOVALDI + RBV or placebo for 12 weeks. This trial was unblinded and all genotype 2 subjects continued on SOVALDI + RBV for 12 weeks, while treatment duration for GT 3 subjects was extended to 24 weeks. Eleven GT 3 subjects had already completed SOVALDI + RBV for 12 weeks at the time of this amendment.1

In other trials of GT 2 subjects:
  • In FISSION, overall SVR12 in treatment‑naïve GT 2 subjects (n=73) taking SOVALDI + RBV for 12 weeks was 95%. Subjects taking Peg‑IFN + RBV for 24 weeks (n=67) achieved an overall SVR12 of 78%1
  • In FUSION, overall SVR12 in treatment‑experienced GT 2 subjects (n=39) taking SOVALDI + RBV for 12 weeks was 82%1
  • In POSITRON, overall SVR12 in IFN-unable GT 2 subjects (n=109) taking SOVALDI + RBV for 12 weeks was 93%. SVR12 was 0% in subjects receiving placebo for 12 weeks1
  • The recommended regimen for GT 2 patients is SOVALDI + RBV for 12 weeks1

GT 2 and 3 study designs for the VALENCE, FISSION, FUSION, and POSITRON trials

IMPORTANT SAFETY INFORMATION

ADVERSE REACTIONS

Most common (20%, all grades) adverse reactions for:

  • SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia, and anemia
  • SOVALDI + ribavirin combination therapy were fatigue and headache

SOVALDI + RBV is the first all-oral, IFN-free regimen for HCV genotype 2 patients1

SOVALDI regimens have demonstrated tolerability with low discontinuation rates1
Adverse events (all grades and without regard to causality) reported in 20% of subjects with HCV in any treatment arm1

aSubjects received weight-based ribavirin (1000 mg per day if weighing <75 kg or 1200 mg per day if weighing 75 kg).1

bSubjects received 800 mg ribavirin per day regardless of weight.

  • This adverse event table is based on pooled data from the 5 phase 3 clinical trials in HCV mono-infected subjects1
  • With the exception of anemia the majority of AEs (incidence of 20%) occurred at severity of grade 1 in SOVALDI-containing regimens1
  • SOVALDI-based regimens demonstrated safety and tolerability with a profile similar to Peg‑IFN and RBV1

IMPORTANT SAFETY INFORMATION

DRUG INTERACTIONS

  • In addition to rifampin and St. John's wort, coadministration of SOVALDI is not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of sofosbuvir, reducing its therapeutic effect.
Discontinuation rates due to AEs across HCV mono-infected patients in phase 3 clinical trials were 0-2% with SOVALDI regimens1
Discontinuation rates due to adverse events by regimen across 5 phase 3 SOVALDI clinical trials1

aSubjects received weight-based ribavirin (1000 mg per day if weighing <75 kg or 1200 mg per day if weighing 75 kg).

bSubjects received 800 mg ribavirin per day regardless of weight.

References
  1. SOVALDI US full Prescribing Information. Gilead Sciences, Inc. Foster City, CA. August 2015.
  2. US Department of Health and Human Services, Center for Drug Evaluation and Research. Draft Guidance for Industry. Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. October 2013.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Contraindications to peginterferon alfa and ribavirin also apply to SOVALDI combination treatment. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.

Personality rights of THE WRIGHT BROTHERS are used with permission of The Wright Family Fund. Represented by GreenLight.

Image of The Fall of the Berlin Wall used with permission of Getty Images.

Image of The Fall of the Berlin Wall used with permission of Getty Images.

GT 3 Patients

SOVALDI + RBV is the first all-oral, IFN-free regimen for HCV genotype 3 patients1

SOVALDI offers GT 3 patients simple dosing in an all-oral, IFN-free regimen1
Recommended Regimen and Treatment Duration for SOVALDI Combination Therapy in HCV GT 3 Patients1

aRibavirin dosage is weight-based (<75 kg = 1000 mg; 75 kg = 1200 mg), administered daily in two divided doses taken orally with food. Patients with renal impairment (CrCl 50 mL/min) require ribavirin dosage reduction; refer to ribavirin prescribing information.

  • The recommended dosage of SOVALDI is one 400 mg tablet taken once daily with or without food1
  • No response-guided therapy is required with SOVALDI1
  • If the other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued1
  • No SOVALDI dosage adjustments are necessary based on advanced age, race, mild or moderate renal impairment (eGFR 30 mL/min/1.73 m2) or hepatic impairment (Child-Pugh Class A, B, or C). The safety and efficacy of SOVALDI have not been established in patients with severe renal impairment, end stage renal disease (ESRD) or decompensated cirrhosis1
  • If a patient has a serious adverse reaction potentially related to RBV, the RBV dosage should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity. RBV may require dosage adjustments; please see prescribing information for RBV1

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Contraindications to peginterferon alfa and ribavirin also apply to SOVALDI combination treatment. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.

SOVALDI + RBV is the first all-oral, IFN-free regimen for HCV genotype 3 patients1

In VALENCE, SOVALDI + RBV delivered high cure (SVR) rates in GT 3 subjects1,a
% SVR12 in GT 3 treatment‑naïve and treatment‑experienced subjects in VALENCE1

aSustained virologic response (SVR12) was the primary endpoint, which was defined as HCV RNA <25 IU/mL at 12 weeks after the end of treatment.1 Achieving SVR is considered a virologic cure.2

VALENCE: GT 2 or 3 treatment‑naïve and -experienced adult subjects1

A trial evaluating SOVALDI in combination with weight-based RBV for the treatment of genotype 2 or 3 HCV infection in treatment‑naïve subjects or subjects who did not achieve SVR with prior interferon-based treatment. The original trial design was a 4:1 randomization to SOVALDI + RBV or placebo for 12 weeks. This trial was unblinded and all genotype 2 subjects continued on SOVALDI + RBV for 12 weeks, while treatment duration for GT 3 subjects was extended to 24 weeks. Eleven GT 3 subjects had already completed SOVALDI + RBV for 12 weeks at the time of this amendment.1

In other trials of GT 3 subjects:
  • In other studies (FISSION, FUSION, POSITRON), SVR12 for GT 3 subjects treated with SOVALDI + RBV for 12 or 16 weeks was suboptimal; therefore, these results are not presented

The recommended regimen for GT 3 patients is SOVALDI + RBV for 24 weeks.1

GT 2 and 3 study designs for the VALENCE, FISSION, FUSION, and POSITRON trials

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone and Another HCV Direct Acting Antiviral (DAA): Amiodarone is not recommended for use with SOVALDI in combination with another DAA 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. 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 of SOVALDI Due to Use with P-gp Inducers: Rifampin and St. John's wort are not recommended for use with SOVALDI as they may significantly decrease sofosbuvir plasma concentrations.
  • Risk Associated with Combination Treatment: Because SOVALDI is used in combination with other antiviral drugs for the treatment of HCV infection, consult the Prescribing Information for these drugs.
  • Related Products Not Recommended: SOVALDI is not recommended for use with other products containing sofosbuvir.

SOVALDI + RBV is the first all-oral, IFN-free regimen for HCV genotype 3 patients1

SOVALDI regimens have demonstrated tolerability with low discontinuation rates1
Adverse events (all grades and without regard to causality) reported in 20% of subjects with HCV in any treatment arm1

aSubjects received weight-based ribavirin (1000 mg per day if weighing <75 kg or 1200 mg per day if weighing 75 kg).

bSubjects received 800 mg ribavirin per day regardless of weight.

  • This adverse event table is based on pooled data from the 5 phase 3 clinical trials in HCV mono-infected subjects1
  • With the exception of anemia the majority of AEs (incidence of 20%) occurred at severity of grade 1 in SOVALDI-containing regimens1
  • SOVALDI-based regimens demonstrated safety and tolerability with a profile similar to Peg‑IFN and RBV1

IMPORTANT SAFETY INFORMATION

ADVERSE REACTIONS

Most common (20%, all grades) adverse reactions for:

  • SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia, and anemia
  • SOVALDI + ribavirin combination therapy were fatigue and headache
Discontinuation rates due to AEs across HCV mono-infected patients in phase 3 clinical trials were 0-2% with SOVALDI regimens1
Discontinuation rates due to adverse events by regimen across 5 phase 3 SOVALDI clinical trials1

aSubjects received weight-based ribavirin (1000 mg per day if weighing <75 kg or 1200 mg per day if weighing 75 kg).

bSubjects received 800 mg ribavirin per day regardless of weight.

References
  1. SOVALDI US full Prescribing Information. Gilead Sciences, Inc. Foster City, CA. August 2015.
  2. US Department of Health and Human Services, Center for Drug Evaluation and Research. Draft Guidance for Industry. Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225333.pdf. Published October 2013. Accessed May 6, 2014.

IMPORTANT SAFETY INFORMATION

DRUG INTERACTIONS

  • In addition to rifampin and St. John's wort, coadministration of SOVALDI is not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of sofosbuvir, reducing its therapeutic effect.

GT 1 and 4 Patients

SOVALDI regimens delivered high cure (SVR) rates in HCV GT 1 patients

SOVALDI offers simple dosing for patients with HCV GT 1 and 41
Recommended Regimen and Treatment Duration for SOVALDI Combination Therapy in HCV GT 1 and 4 Patients1

aSee peginterferon (Peg‑IFN) alfa prescribing information for dosage recommendation.

bRibavirin dosage is weight-based (<75 kg = 1000 mg; 75 kg = 1200 mg), administered daily in two divided doses taken orally with food. Patients with renal impairment (CrCl 50 mL/min) require ribavirin dosage reduction; refer to ribavirin prescribing information.

  • The recommended dosage of SOVALDI is one 400 mg tablet taken once daily with or without food1
  • No response-guided therapy is required with SOVALDI1
  • 24 weeks of SOVALDI + RBV is the first approved all-oral regimen that can be considered for HCV GT 1 patients who are ineligible to receive an IFN-based regimen1
  • If the other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued1
  • No SOVALDI dosage adjustments are necessary based on advanced age, race, mild or moderate renal impairment (estimated glomerular filtration rate (eGFR) 30 mL/min/1.73 m2) or hepatic impairment (Child-Pugh Class A, B, or C). The safety and efficacy of SOVALDI have not been established in patients with severe renal impairment, end stage renal disease (ESRD) or decompensated cirrhosis1
  • If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. Refer to the peginterferon alfa and ribavirin prescribing information for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dose1

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Contraindications to peginterferon alfa and ribavirin also apply to SOVALDI combination treatment. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.

SOVALDI regimens delivered high cure (SVR) rates in HCV GT 1 patients

In NEUTRINO, SOVALDI + Peg‑IFN + RBV delivered high cure (SVR) rates with just 12 weeks of therapy in treatment‑naïve subjects with HCV GT 11,a
% SVR12 in GT 1 and 4 subjects in NEUTRINO1

aSustained virologic response (SVR12) was the primary endpoint, which was defined as HCV RNA <25 IU/mL at 12 weeks after the end of treatment.1 Achieving SVR is considered a virologic cure.2

NEUTRINO: GT 1 and 4 treatment‑naïve adult subjects1

An open-label, single-arm trial evaluating 12 weeks of treatment with SOVALDI in combination with peginterferon (Peg‑IFN) alfa 2a and weight-based ribavirin (RBV) in treatment‑naïve subjects (N=327) with genotype 1, 4, 5 or 6 HCV infection compared to a pre-specified historical control.1

GT 1 and 4 study design of the NEUTRINO trial

NEUTRINO: GT 1 and 4 treatment‑naïve adult subjects1

NEUTRINO was an open-label, single-arm trial that evaluated 12 weeks of treatment with SOVALDI in combination with Peg‑IFN and RBV in treatment‑naïve subjects with genotype 1, 4, 5 or 6 HCV infection compared to prespecified historical control.

  • Available data on subjects with genotype 5 or 6 HCV treated with SOVALDI + peginterferon alfa + ribavirin for 12 weeks were insufficient for dosing recommendations; therefore, these results are not presented1
  • SOVALDI + Peg‑IFN + RBV is an approved regimen for GT 1 treatment‑experienced patients, with an estimated SVR rate of 71%1
    • The response rate in treatment‑naïve subjects with difficult-to-treat factors (GT 1 subjects with IL28B non-C/C alleles, HCV RNA >800,000 IU/mL, and METAVIR F3/F4 fibrosis) in NEUTRINO (n=52) may approximate the response rate in patients who previously failed pegylated interferon and ribavirin therapy1

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone and Another HCV Direct Acting Antiviral (DAA): Amiodarone is not recommended for use with SOVALDI in combination with another DAA 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. 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 of SOVALDI Due to Use with P-gp Inducers: Rifampin and St. John's wort are not recommended for use with SOVALDI as they may significantly decrease sofosbuvir plasma concentrations.
  • Risk Associated with Combination Treatment: Because SOVALDI is used in combination with other antiviral drugs for the treatment of HCV infection, consult the Prescribing Information for these drugs.
  • Related Products Not Recommended: SOVALDI is not recommended for use with other products containing sofosbuvir.
In NEUTRINO, SOVALDI + Peg‑IFN + RBV provided high virologic cure (SVR) rates for patients with compensated cirrhosis1,a,b
% SVR12 in GT 1 and 4 non-cirrhotic and cirrhotic subjects in NEUTRINO1,a

aCirrhosis was defined as any one of the following: a liver-biopsy sample showing cirrhosis; transient elastography (FibroScan®) showing cirrhosis or liver stiffness of more than 12.5kPa; a serum FibroTest® score of more than 0.75 (on a scale of 0 to 1) plus a ratio of aspartate aminotransferase to platelets of more than 2 during screening.4

bSustained virologic response (SVR12) was the primary endpoint, which was defined as HCV RNA <25 IU/mL at 12 weeks after the end of treatment.1 Achieving SVR is considered a virologic cure.2

  • 17% of patients treated with SOVALDI in NEUTRINO had compensated cirrhosis at baseline (53/320)1

IMPORTANT SAFETY INFORMATION

ADVERSE REACTIONS

Most common (20%, all grades) adverse reactions for:

  • SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia, and anemia
  • SOVALDI + ribavirin combination therapy were fatigue and headache

SOVALDI regimens delivered high cure (SVR) rates in HCV GT 1 patients

SOVALDI regimens have demonstrated tolerability with low discontinuation rates
Adverse events (all grades and without regard to causality) reported in 20% of subjects with HCV in any treatment arm1

aSubjects received weight-based ribavirin (1000 mg per day if weighing <75 kg or 1200 mg per day if weighing 75 kg).

bSubjects received 800 mg ribavirin per day regardless of weight.

  • This adverse event table is based on pooled data from the 5 phase 3 clinical trials in HCV mono-infected subjects1
  • With the exception of anemia the majority of AEs (incidence of 20%) occurred at severity of grade 1 in SOVALDI-containing regimens1
  • SOVALDI-based regimens demonstrated safety and tolerability with a profile similar to Peg‑IFN and RBV1
Discontinuation rates due to AEs across HCV mono-infected patients in phase 3 clinical trials were 0-2% with SOVALDI regimens1
Discontinuation rates due to adverse events by regimen across 5 phase 3 SOVALDI clinical trials1

aSubjects received weight-based ribavirin (1000 mg per day if weighing <75 kg or 1200 mg per day if weighing 75 kg).

bSubjects received 800 mg ribavirin per day regardless of weight.

References
  1. SOVALDI US full Prescribing Information. Gilead Sciences, Inc. Foster City, CA. August 2015.
  2. US Department of Health and Human Services, Center for Drug Evaluation and Research. Draft Guidance for Industry. Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. October 2013.
  3. Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013;368(20)(suppl).
  4. Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013;368(20):1878-1887.

IMPORTANT SAFETY INFORMATION

DRUG INTERACTIONS

  • In addition to rifampin and St. John's wort, coadministration of SOVALDI is not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of sofosbuvir, reducing its therapeutic effect.

Image of The Fall of the Berlin Wall used with permission of Getty Images.

Other Treatment Considerations
Other Treatment Considerations

SOVALDI regimens are indicated to treat HCV in HCV/HIV-1 co-infected patients and patients with HCC awaiting liver transplant

HCV/HIV-1 co-infected patients receive the same regimens as HCV mono-infected patients1
Recommended Regimen and Treatment Duration for SOVALDI Combination Therapy in HCV Mono-infected and HCV/HIV-1 Co-infected Patients1

aSee peginterferon (Peg‑IFN) alfa prescribing information for dosage recommendation for patients with genotype 1 or 4 HCV.

bRibavirin dosage is weight-based (<75 kg = 1000 mg; 75 kg = 1200 mg), administered daily in two divided doses taken orally with food. Patients with renal impairment (CrCl 50 mL/min) require ribavirin dosage reduction; refer to ribavirin prescribing information.

  • The recommended dosage of SOVALDI is one 400 mg tablet taken once daily with or without food1
  • No response-guided therapy is required with SOVALDI1
  • 24 weeks of SOVALDI + RBV is the first approved all-oral regimen that can be considered for HCV GT 1 patients who are ineligible to receive an IFN-based regimen1
  • If the other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued1
  • No SOVALDI dosage adjustments are necessary based on advanced age, race, mild or moderate renal impairment (eGFR 30 mL/min/1.73 m2) or hepatic impairment (Child-Pugh Class A, B, or C). The safety and efficacy of SOVALDI have not been established in patients with severe renal impairment, end stage renal disease (ESRD) or decompensated cirrhosis1
  • If a patient has a serious adverse reaction potentially related to Peg‑IFN and/or RBV, the Peg‑IFN and/or RBV dosage should be reduced or discontinued. Refer to the Peg‑IFN and RBV prescribing information for additional information about how to reduce and/or discontinue the Peg‑IFN and/or RBV dosage1

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Contraindications to peginterferon alfa and ribavirin also apply to SOVALDI combination treatment. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.
In PHOTON-1, SOVALDI + RBV delivered high SVR rates in subjects with HCV/HIV-1 co-infection1,a
% SVR12 in GT 1, 2 and 3 subjects in PHOTON-11,a

aSustained virologic response (SVR12) was the primary endpoint, which was defined as HCV RNA <25 IU/mL at 12 weeks after the end of treatment.1 Achieving SVR is considered a virologic cure.2

PHOTON-1: GT 1, 2 and 3 HCV/HIV-1 co-infected subjects1

An open-label trial evaluating the safety and efficacy of 12 or 24 weeks of treatment with SOVALDI + RBV in subjects with HCV GT 1, 2 or 3 infection who are co-infected with HIV-1.1

  • 12 weeks of SOVALDI + Peg‑IFN + RBV is the recommended regimen for all GT 1 patients
  • 24 weeks of SOVALDI + RBV is the first approved all-oral regimen that can be considered for HCV GT 1 patients who are ineligible to receive an IFN-based regimen1
  • The safety profile in HCV/HIV-1 co-infected subjects was similar to that observed in HCV mono-infected subjects1

Study design for co-infected patients in the PHOTON-1 trial

PHOTON-1: GT 1, 2 and 3 HCV/HIV-1 co-infected subjects1

SOVALDI was studied in an open-label clinical trial evaluating the safety and efficacy of 12 or 24 weeks of treatment with SOVALDI and RBV in subjects with genotype 1, 2 or 3 chronic hepatitis C co-infected with HIV-1. Genotype 2 and 3 subjects were either HCV treatment‑naïve or –experienced, whereas genotype 1 subjects were all treatment‑naïve. Subjects received 400 mg SOVALDI and weight-based RBV (1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing 75 kg) daily for 12 or 24 weeks based on genotype and prior treatment history. Subjects were either not on antiretroviral therapy with a CD4+ cell count >500 cells/mm3 or had virologically suppressed HIV-1 with a CD4+ cell count >200 cells/mm3. Efficacy data 12 weeks post treatment are available for 210 subjects.

* The study design also included GT 2 treatment‑experienced and GT 3 treatment‑naïve subjects, which are not depicted here.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone and Another HCV Direct Acting Antiviral (DAA): Amiodarone is not recommended for use with SOVALDI in combination with another DAA 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. 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 of SOVALDI Due to Use with P-gp Inducers: Rifampin and St. John's wort are not recommended for use with SOVALDI as they may significantly decrease sofosbuvir plasma concentrations.
  • Risk Associated with Combination Treatment: Because SOVALDI is used in combination with other antiviral drugs for the treatment of HCV infection, consult the Prescribing Information for these drugs.
  • Related Products Not Recommended: SOVALDI is not recommended for use with other products containing sofosbuvir.

SOVALDI regimens are indicated to treat HCV in HCV/HIV-1 co-infected patients and patients with HCC awaiting liver transplant

SOVALDI + RBV is the first all-oral regimen for patients with HCC meeting the Milan criteria who are awaiting liver transplantation to prevent post-transplant HCV reinfection1
Recommended Regimen and Treatment Duration for SOVALDI Combination Therapy in HCV-infected HCC Patients Awaiting Liver Transplant1

aRibavirin dosage is weight-based (<75 kg = 1000 mg; 75 kg = 1200 mg), administered daily in two divided doses taken orally with food. Patients with renal impairment (CrCl 50 mL/min) require ribavirin dosage reduction; refer to ribavirin prescribing information.1

  • In patients with hepatocellular carcinoma (HCC) awaiting liver transplantation, SOVALDI in combination with ribavirin is recommended for up to 48 weeks or until the time of liver transplantation, whichever occurs first1
  • The safety and efficacy of SOVALDI have not been established in post-liver transplant patients1
  • No response-guided therapy is required with SOVALDI1

IMPORTANT SAFETY INFORMATION

ADVERSE REACTIONS

Most common (20%, all grades) adverse reactions for:

  • SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia, and anemia
  • SOVALDI + ribavirin combination therapy were fatigue and headache
SOVALDI + RBV was effective in HCC patients awaiting liver transplantation to prevent post-transplant HCV reinfection1
% pTVR12 in HCC subjects awaiting liver transplantation1,a,b

a

Study included HCV-infected subjects, regardless of genotype, with HCC meeting the Milan criteria (defined as the presence of a tumor 5 cm or less in diameter in patients with single HCCs (hepatocellular carcinomas) and no more than 3 tumor nodules, each 3 cm or less in diameter in patients with multiple tumors and no extrahepatic manifestations of the cancer or evidence of vascular invasion of tumor). 45 subjects had HCV genotype 1; 44 subjects had a baseline CPT score less than 7; and all subjects had a baseline unadjusted MELD score 14.1

bpTVR = post-transplant virologic response, defined as HCV RNA <LLOQ at 12 weeks post-transplant.

  • 61 subjects diagnosed with hepatocellular carcinoma (HCC) awaiting liver transplantation received SOVALDI + RBV for up to 48 weeks to prevent post-transplant HCV reinfection1
  • Of these 61 subjects, 41 underwent liver transplantation, with 37 having HCV RNA <LLOQ at time of transplantation1
  • pTVR was 64% among the 36 of these 37 subjects who were evaluable and who reached the 12-week post-transplant time point1

Study design for patients with HCC awaiting liver transplantation

Patients awaiting liver transplantation1,3

A single-arm, open-label clinical study in liver transplantation candidates with HCV and HCC meeting Milan criteria (n=61); the primary endpoint of the trial was post-transplant virologic response (pTVR) defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks post-transplant.1,3,a

a Study included HCV-infected subjects, regardless of genotype, with HCC meeting the Milan criteria (defined as the presence of a tumor 5 cm or less in diameter in patients with single HCCs (hepatocellular carcinomas) and no more than 3 tumor nodules, each 3 cm or less in diameter in patients with multiple tumors and no extrahepatic manifestations of the cancer or evidence of vascular invasion of tumor). 45 subjects had HCV genotype 1; 44 subjects had a baseline CPT score less than 7; and all subjects had a baseline unadjusted MELD score ≤14.1

References
  1. SOVALDI US full Prescribing Information. Gilead Sciences, Inc. Foster City, CA. August 2015.
  2. US Department of Health and Human Services, Center for Drug Evaluation and Research. Draft Guidance for Industry. Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. October 2013.
  3. Curry MP, Forns X, Chung R, Terrault N, et al. Pretransplant Sofosbuvir and Ribavirin to Prevent Recurrence of HCV Infection After Liver Transplantation. Abstract presented at: 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); November 1-5, 2013; Washington, DC.

IMPORTANT SAFETY INFORMATION

DRUG INTERACTIONS

  • In addition to rifampin and St. John's wort, coadministration of SOVALDI is not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of sofosbuvir, reducing its therapeutic effect.

Important Safety Information

CONTRAINDICATIONS
  • Contraindications to peginterferon alfa and ribavirin also apply to SOVALDI combination treatment. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.
WARNINGS AND PRECAUTIONS
  • Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone and Another HCV Direct Acting Antiviral (DAA): Amiodarone is not recommended for use with SOVALDI in combination with another DAA 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. 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 of SOVALDI Due to Use with P-gp Inducers: Rifampin and St. John's wort are not recommended for use with SOVALDI as they may significantly decrease sofosbuvir plasma concentrations.
  • Risk Associated with Combination Treatment: Because SOVALDI is used in combination with other antiviral drugs for the treatment of HCV infection, consult the Prescribing Information for these drugs.
  • Related Products Not Recommended: SOVALDI is not recommended for use with other products containing sofosbuvir.
ADVERSE REACTIONS

    Most common (20%, all grades) adverse reactions for:

  • SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia, and anemia
  • SOVALDI + ribavirin combination therapy were fatigue and headache
DRUG INTERACTIONS
  • In addition to rifampin and St. John's wort, coadministration of SOVALDI is not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of sofosbuvir, reducing its therapeutic effect.

Access and Resources

Support Path® is a suite of resources designed to help patients start with SOVALDI and move toward treatment completion

Getting started

Support Path helps patients access therapy and get off to an efficient start
  • Benefits investigation and prior authorization support
  • Co-pay and other financial assistance
  • A specialty pharmacy finder

Co-pay coupon

The SOVALDI co-pay coupon may help eligible patients lower their out-of-pocket costs.

With a co-pay coupon, most eligible patients may pay no more than $5 per co-pay (restrictions apply)

To register and read full terms and conditions, click here
Or call 1-855-769-7284

  • Not valid for patients enrolled in government healthcare prescription drug programs, such as Medicare Part D and Medicaid. Patients in the coverage gap known as the "donut hole" also are not eligible
  • The SOVALDI co-pay coupon program will cover the out-of-pocket costs for SOVALDI prescriptions up to a maximum of 25% of the catalog price of a 12-week regimen of SOVALDI

Help along the way

Support Path is ready to assist patients along the way toward treatment completion
  • Educational resources, support for adherence, and progress tracking
  • A 24/7 help line with nurses on call can provide answers and assistance
  • Ongoing support for access and reimbursement, including refill authorization

Enroll

Go to MySupportPath.com or call 1-855-7-MYPATH (1-855-769-7284) to get started.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Contraindications to peginterferon alfa and ribavirin also apply to SOVALDI combination treatment. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.

WARNINGS AND PRECAUTIONS

  • Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone and Another HCV Direct Acting Antiviral (DAA): Amiodarone is not recommended for use with SOVALDI in combination with another DAA 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. 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 of SOVALDI Due to Use with P-gp Inducers: Rifampin and St. John's wort are not recommended for use with SOVALDI as they may significantly decrease sofosbuvir plasma concentrations.
  • Risk Associated with Combination Treatment: Because SOVALDI is used in combination with other antiviral drugs for the treatment of HCV infection, consult the Prescribing Information for these drugs.
  • Related Products Not Recommended: SOVALDI is not recommended for use with other products containing sofosbuvir.

Resources to help you in the treatment of patients with HCV

Centers for Disease Control and Prevention: Hepatitis C information for health professionals

US Preventive Services Task Force: Screening for hepatitis C virus infection in adults

American College of Gastroenterology: hepatitis C treatment resources

AASLD/IDSA HCV Guidelines

IMPORTANT SAFETY INFORMATION

ADVERSE REACTIONS

Most common (20%, all grades) adverse reactions for:

  • SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia, and anemia
  • SOVALDI + ribavirin combination therapy were fatigue and headache

DRUG INTERACTIONS

  • In addition to rifampin and St. John's wort, coadministration of SOVALDI is not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of sofosbuvir, reducing its therapeutic effect.

Interactive Prescribing Information

Review the SOVALDI Full Prescribing Information in an easy-to-use interactive format.

This information is intended for US healthcare professionals

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