HEPATITIS C TREATMENT

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  • HEPATITIS C TREATMENT
    • NOTE: The treatment regimens presented here are based on FDA-approved indications and/or published trials. The AASLD website gives other treatment recommendations, many of which are based on small, unpublished trials.




  • GENOTYPE 1

    • Epclusa® (sofosbuvir + velpatasvir) treatment regimens for HCV genotype 1

      • Ribavirin dosing is weight-based: < 165 lbs (75 kg) - 1000 mg a day; ≥ 165 lbs (75 kg) - 1200 mg a day; ribavirin is given in 2 divided doses
      • Epclusa = velpatasvir 100 mg + sofosbuvir 400 mg
      HCV genotype 1 treatment
      Reference - Epclusa® PI
      Patient populationRegimenDuration
      Patients without cirrhosis and patients with
      compensated cirrhosis (Child-Pugh A)      		Epclusa® once daily12 weeks
      Patients with decompensated
      cirrhosis (Child-Pugh B/C)      		Epclusa® once daily + ribavirin12 weeks

    • Epclusa® (sofosbuvir + velpatasvir) HCV genotype 1 trials

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosis
      (% of patients)      		SVR at 12 weeks
      (cure)      		Other
      Epclusa® once daily for 12 weeksN=328
      (ASTRAL-1)      		33%22%1a - 98% (206/210)
      1b - 99% (117/118)
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Ribavirin dosing was weight-based: < 165 lbs (75 kg) - 1000 mg a day;
        ≥ 165 lbs (75 kg) - 1200 mg a day; ribavirin is given in 2 divided doses
      • In ASTRAL-4, 90% of the patients had Child-Pugh Class B liver failure
      Epclusa® once daily for 12 weeksN=68
      (ASTRAL-4)      		64%100%1a - 88% (44/50)
      1b - 89% (16/18)
      Epclusa® once daily + ribavirin for 12 weeksN=68
      (ASTRAL-4)      		54%100%1a - 94% (51/54)
      1b - 100% (14/14)
      Epclusa® once daily for 24 weeksN=71
      (ASTRAL-4)      		47%100%1a - 93% (51/55)
      1b - 88% (14/16)


    • Harvoni™ (sofosbuvir + ledipasvir) treatment regimens for HCV genotype 1

      • Harvoni™ = ledipasvir 90 mg + sofosbuvir 400 mg
      HCV genotype 1 treatment
      Reference - Harvoni™ PI
      Patient populationRegimenDuration
      Treatment-naïve without cirrhosis,
      baseline viral load < 6 million IU/ml      		Harvoni™ once daily8 or 12 weeks
      Treatment-naïve with or without cirrhosisHarvoni™ once daily12 weeks
      Treatment-experienced without cirrhosisHarvoni™ once daily12 weeks
      Treatment-experienced with cirrhosisHarvoni™ once daily24 weeks

    • Harvoni™ (sofosbuvir + ledipasvir) HCV genotype 1 trials

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosis
      (% of patients)      		SVR at 12 weeks
      (cure)      		Other
      Harvoni™ once daily for 8 weeksN=215
      (ION-3)      		NO0%94%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • In all trials, the response was similar between genotype 1a and 1b
      • In all trials, baseline viral load had no effect on response
      • In all trials, Interleukin 28B (IL28B) status had no effect on response
      • Harvoni™ = ledipasvir 90 mg + sofosbuvir 400 mg
      • Sof = Sofosbuvir
      Harvoni™ once daily for 12 weeksN=216
      (ION-3)      		NO0%95%
      Harvoni™ once daily for 12 weeksN=214
      (ION-1)      		NO16%, did not
      affect response      		99%
      Harvoni™ once daily for 24 weeksN=217
      (ION-1)      		NO16%, did not
      affect response      		98%
      Harvoni™ once daily for 12 weeksN=109
      (ION-2)      		YES20%No cirrhosis - 94%
      Cirrhosis - 86%
      Harvoni™ once daily for 24 weeksN=109
      (ION-2)      		YES20%, did not
      affect response      		99%
      Harvoni™ + weight-based ribavirin
      for 12 or 24 weeks      		N=102
      (SOLAR-1)      		YES
      65%      		100%Child-Pugh B - 88%
      Child-Pugh C - 87%
      • Ribavirin dosing was weight-based: < 165 lbs (75 kg) - 1000 mg a day;
        > 165 lbs (75 kg) - 1200 mg a day; ribavirin is given in 2 divided doses
      • Cure rates were similar for 12 and 24 weeks of treatment
      • Another arm of the study (not detailed here) involved
        patients who were status-post liver transplant
      • 3 of the patients had HCV genotype 4


    • Sofosbuvir (Sovaldi®) + simeprevir (Olysio®) treatment regimens for HCV genotype 1

      • See simeprevir (Olysio®) and sofosbuvir (Sovaldi®) for more
      • Treatment failure defined as previous treatment failure with PegIFN-based therapy
      • Simeprevir is not recommended in patients who failed previous protease inhibitors (e.g. telaprevir, boceprevir)
      HCV genotype 1 treatment
      Reference - Olysio PI
      Patient populationRegimenDuration
      Treatment-naïve and previous treatment failure
      without cirrhosis      		Simeprevir 150 mg + Sofosbuvir 400 mg once daily12 weeks
      Treatment-naïve and previous treatment failure
      with cirrhosis      		Simeprevir 150 mg + Sofosbuvir 400 mg once daily24 weeks

    • Sofosbuvir (Sovaldi®) + simeprevir (Olysio®) HCV genotype 1 trials

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosis
      (% of patients)      		SVR at 12 weeks
      (cure)      		Other
      Simeprevir 150 mg + Sofosbuvir 400 mg
      once daily for 12 weeks      		N=14
      (COSMOS)      		YES0%93%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Previous treatment was with PegIFN and ribavirin
      • Ribavirin was added in other arms of the trial, and it had no significant effect on cure rates
      • Treatment duration (12 vs 24 weeks) did not have a significant effect on cure rates
      • There was no significant difference in cure rates between Genotype 1a and 1b
      • There was no significant difference in cure rates based on presence of Q80K polymorphism
      • There was no significant difference in cure rates between Interleukin 28B (IL28B) genotypes
      • See simeprevir (Olysio®) and sofosbuvir (Sovaldi®) for more
      Simeprevir 150 mg + Sofosbuvir 400 mg
      once daily for 24 weeks      		N=15
      (COSMOS)      		YES0%93%
      Simeprevir 150 mg + Sofosbuvir 400 mg
      once daily for 12 weeks      		N=14
      (COSMOS)      		YES and NO100%93%
      Simeprevir 150 mg + Sofosbuvir 400 mg
      once daily for 24 weeks      		N=16
      (COSMOS)      		YES and NO100%100%
      Simeprevir 150 mg + Sofosbuvir 400 mg
      once daily for 8 weeks      		N=155
      (OPTIMIST-1)      		YES and NO0%83%
      Simeprevir 150 mg + Sofosbuvir 400 mg
      once daily for 12 weeks      		N=155
      (OPTIMIST-1)      		26%0%Treatment-naïve - 97% (112/115)
      Previous treatment - 95% (38/40)
      Simeprevir 150 mg + Sofosbuvir 400 mg
      once daily for 12 weeks      		N=103
      (OPTIMIST-2)      		51%100%Treatment-naïve - 88% (44/50)
      Previous treatment - 79% (42/53)


    • Sofosbuvir (Sovaldi®) + daclatasvir (Daklinza™) ± ribavirin treatment regimens for HCV genotype 1

      • HCV genotype 1 treatment
      Reference - Daklinza PI
      Patient populationRegimenDuration
      Without cirrhosis or
      Child-Pugh A cirrhosis      		Sofosbuvir 400 mg once daily + daclatasvir 60 mg once daily12 weeks
      Child-Pugh B and C cirrhosis or
      post-liver transplant      		Sofosbuvir 400 mg once daily + daclatasvir 60 mg once daily + ribavirin*12 weeks

    • Sofosbuvir + daclatasvir ± ribavirin HCV genotype 1 trials

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosis
      (% of patients)      		SVR at 12 weeks
      (cure)      		Other
      Sofosbuvir 400 mg once daily +
      daclatasvir 60 mg once daily
      for 8 weeks      		N=41
      (ALLY-2)      		NO?76% (31/41)
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • All patients were coinfected with HIV
      • NS5A polymorphisms affected the response to daclatasvir in trials. See polymorphisms for more.
      • See sofosbuvir and daclatasvir for more
      Sofosbuvir 400 mg once daily +
      daclatasvir 60 mg once daily
      for 12 weeks      		N=83
      (ALLY-2)      		NO**see Other96% (80/83)
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • All patients were coinfected with HIV
      • Genotype 1a and 1b status did not affect outcomes
      • **Only patients with compensated cirrhosis were included. Number of patients with cirrhosis was small. Cirrhosis did not
        affect outcomes. For all 12-week groups (treatment-naïve, and previous treatment), SVR with cirrhosis was 91% (20/22).
      • NS5A polymorphisms affected the response to daclatasvir in trials. See polymorphisms for more.
      • See sofosbuvir and daclatasvir for more
      Sofosbuvir 400 mg once daily +
      daclatasvir 60 mg once daily
      for 12 weeks      		N=44
      (ALLY-2)      		YES**see Other98% (43/44)
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • All patients were coinfected with HIV
      • Genotype 1a and 1b status did not affect outcomes
      • The majority of patients had been previously treated with PegIFN/ribavirin (71%) or PegIFN/ribavirin/protease inhibitor (21%)
      • **Only patients with compensated cirrhosis were included. Number of patients with cirrhosis was small. Cirrhosis did not
        affect outcomes. For all 12-week groups (treatment-naïve, and previous treatment), SVR with cirrhosis was 91% (20/22).
      • NS5A polymorphisms affected the response to daclatasvir in trials. See polymorphisms for more.
      • See sofosbuvir and daclatasvir for more
      Sofosbuvir 400 mg once daily +
      daclatasvir 60 mg once daily +
      ribavirin for 12 weeks      		N=45
      (ALLY-1)      		YES - 59%
      NO - 41%      		100%1a - 76% (26/34)
      1b - 100% (11/11)
      Child-Pugh A 91% (10/11)
      Child-Pugh B 92% (22/24)
      Child-Pugh C 50% (5/10)
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Ribavirin dosing was 600 mg once daily initially with titration to 1000 mg/day if tolerated
      • NS5A polymorphisms affected the response to daclatasvir in trials. See polymorphisms for more.
      • See sofosbuvir, daclatasvir, and ribavirin for more


    • Viekira Pak™/Viekira XR™ treatment regimens for HCV genotype 1

      • ** 12 weeks may be considered in patients who are treatment-naïve or who were partial responders or relapsers with previous PegIFN/ribavirin treatment (see TURQUOISE II trial below)
      • Recommendations are the same regardless of prior treatment with PegIFN/Ribavirin
      • Ribavirin dosing is weight-based: < 165 lbs (75 kg) - 1000 mg a day; > 165 lbs (75 kg) - 1200 mg a day; ribavirin is given in 2 divided doses
      HCV genotype 1 treatment
      Reference - Viekira Pak/Viekira XR PI
      Patient populationRegimenDuration
      Genotype 1a without cirrhosisViekira Pak or Viekira XR + weight-based ribavirin12 weeks
      Genotype 1a with cirrhosis (Child-Pugh A)Viekira Pak or Viekira XR + weight-based ribavirin24 weeks**
      Genotype 1b with or without cirrhosis (Child-Pugh A)Viekira Pak or Viekira XR12 weeks
      Liver transplant recipient
      normal liver function and Metavir ≤ 2
      genotype 1a and 1b      		Viekira Pak or Viekira XR + weight-based ribavirin24 weeks

    • Viekira Pak™ HCV genotype 1 trials

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosis
      (% of patients)      		SVR at 12 weeks
      (cure)      		Other
      Viekira Pak™ + ribavirin
      for 12 weeks      		N=473
      (SAPPHIRE I)      		NO0%1a - 95.3%
      1b - 98%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Ribavirin dosing was weight-based (1000 mg daily if the body weight was < 75 kg and 1200 mg daily if the body weight was ≥75 kg)
      • Previous treatment defined as prior treatment with peginterferon and ribavirin

      • Null responder - PegIFN/ribavirin for 12 weeks with < 2 log10 IU/ml reduction in viral load; or PegIFN/ribavirin for 4 weeks with < 1 log10 IU/ml reduction in viral load
      • Partial responder - PegIFN/ribavirin with > 2 log10 IU/ml reduction in viral load at 12 weeks, but detectable viral load at end of treatment
      • Relapser - at least 36 weeks of PegIFN/ribavirin with undetectable viral load at end of treatment and then had detectable viral load within 52 weeks
      TURQUOISE II results
      Prior PegIFN treatment
      status      		1a
      Viekira Pak + ribavirin
      for 24 weeks      		1a
      Viekira Pak + ribavirin
      for 12 weeks      		1b
      Viekira Pak + ribavirin
      for 12 weeks
      No prior treatment93% (52/56)93% (59/64)100% (22/22)
      Null responder93% (39/42)80% (40/50)100% (25/25)
      Partial responder100% (10/10)100% (11/11)86% (6/7)
      Relapser100% (13/13)93% (14/15)100% (14/14)
      Viekira Pak™ + ribavirin
      for 12 weeks      		N=297
      (SAPPHIRE II)      		YES0%1a - 96%
      1b - 96.7%
      Viekira Pak™ ± ribavirin
      for 12 weeks      		N=179
      (PEARL II)      		YES0%All patients had 1b
      With ribavirin (N=91) - 96.6%
      Without ribavirin (N=95) - 100%
      Viekira Pak™ ± ribavirin
      for 12 weeks      		N=419
      (PEARL III)      		NO0%All patients had 1b
      With ribavirin (N=210) - 99.5%
      Without ribavirin (N=209) - 99%
      Viekira Pak™ ± ribavirin
      for 12 weeks      		N=305
      (PEARL IV)      		NO0%All patients had 1a
      With ribavirin (N=100) - 97%
      Without ribavirin (N=205) - 90.2%
      Viekira Pak™ + ribavirin
      for 12 or 24 weeks      		N=380
      (TURQUOISE II)      		58%
      previously-treated      		100%
      (Metavir > 3)
      (Child-Pugh A)      		**see TURQUOISE II results under Other


    • Zepatier™ (elbasvir + grazoprevir) treatment regimens for HCV genotype 1

      • Patients with HCV 1a should be checked for polymorphisms before starting therapy (see NS5A polymorphism for more)
      • Protease inhibitor = boceprevir, simeprevir, telaprevir; PegIFN = pegylated interferon
      • Zepatier = elbasvir 50 mg + grazoprevir 100 mg
      • Ribavirin dosing is weight-based: < 66 kg (145 pounds) - 800 mg per day; 66 - 80 kg (145 - 176 pounds) - 1000 mg per day;
        81 - 105 kg (177 - 231 pounds) - 1200 mg per day; > 105 kg (231 pounds) - 1400 mg per day
      HCV genotype 1 treatment
      Reference - Zepatier PI
      HCV genotypeTreatment historyRegimen
      1a
      without polymorphisms      		PegIFN/ribavirin or
      treatment-naïve      		Zepatier™ for 12 weeks
      1a
      with polymorphisms      		PegIFN/ribavirin or
      treatment-naïve      		Zepatier™ + ribavirin for 16 weeks
      1a or 1bPegIFN/ribavirin/Protease inhibitorZepatier™ + ribavirin for 12 weeks
      1bPegIFN/ribavirin or
      treatment-naïve      		Zepatier™ for 12 weeks

    • Zepatier™ HCV genotype 1 trials

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosis
      (% of patients)      		SVR at 12 weeks
      (cure)      		Other
      Zepatier™
      for 12 weeks      		N=288
      (C-EDGE TN)      		NO24%, did not
      affect response      		1a - 92% (144/157)
      1b - 98% (129/131)
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Patients with HCV 1a NS5A polymorphisms had lower response rates
      • Ribavirin dosing was weight-based: < 66 kg (145 pounds) - 800 mg per day; 66 - 80 kg (145 - 176 pounds) - 1000 mg per day;
        81 - 105 kg (177 - 231 pounds) - 1200 mg per day; > 105 kg (231 pounds) - 1400 mg per day
      Zepatier™
      for 12 weeks      		N=96
      (C-EDGE TE)      		YES32%, did not
      affect response      		1a - 90% (55/61)
      1b - 100% (35/35)
      Zepatier™ + ribavirin
      for 16 weeks      		N=96
      (C-EDGE TE)      		YES33%, did not
      affect response      		1a - 95% (55/58)
      1b - 100% (38/38)


    • Technivie™ treatment regimens for HCV genotype 1b

      • Technivie contains paritaprevir, ombitasvir, and ritonavir in one tablet. Technivie dosage is two tablets once daily.
      • Regimens are from the PEARL-I GT1b trial
      • Technivie has not been FDA-approved to treat HCV genotype 1b
      HCV genotype 1b treatment
      Reference - PEARL-I GT1b trial
      Patient populationRegimenDuration
      Genotype 1b without cirrhosisTechnivie12 weeks
      Genotype 1b with cirrhosisTechnivie24 weeks

    • Technivie™ HCV genotype 1b trials

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosis
      (% of patients)      		SVR at 12 weeks
      (cure)      		Other
      Technivie™
      for 12 weeks      		N=42
      PEARL-I GT1b      		NO0%1b - 95%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Technivie contains paritaprevir, ombitasvir, and ritonavir in one tablet.
        Technivie dosage is two tablets once daily.
      Technivie™
      for 12 weeks      		N=40
      PEARL-I GT1b      		YES0%1b - 90%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Technivie contains paritaprevir, ombitasvir, and ritonavir in one tablet.
        Technivie dosage is two tablets once daily.
      • Previous treatment defined as prior null response to pegylated interferon and ribavirin treatment
      Technivie™
      for 24 weeks      		N=47
      PEARL-I GT1b      		NO100%1b - 98%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Technivie contains paritaprevir, ombitasvir, and ritonavir in one tablet.
        Technivie dosage is two tablets once daily.
      Technivie™
      for 24 weeks      		N=52
      PEARL-I GT1b      		YES100%1b - 96%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Technivie contains paritaprevir, ombitasvir, and ritonavir in one tablet.
        Technivie dosage is two tablets once daily.
      • Previous treatment defined as null response, partial response, or relapse with pegylated interferon and ribavirin

  • GENOTYPE 2

    • Epclusa® (sofosbuvir + velpatasvir) treatment regimens for HCV genotype 2

      • Ribavirin dosing is weight-based: < 165 lbs (75 kg) - 1000 mg a day; ≥ 165 lbs (75 kg) - 1200 mg a day; ribavirin is given in 2 divided doses
      • Epclusa = velpatasvir 100 mg + sofosbuvir 400 mg
      HCV genotype 2 treatment
      Reference - Epclusa® PI
      Patient populationRegimenDuration
      Patients without cirrhosis and patients with
      compensated cirrhosis (Child-Pugh A)      		Epclusa® once daily12 weeks
      Patients with decompensated
      cirrhosis (Child-Pugh B/C)      		Epclusa® once daily + ribavirin12 weeks

    • Epclusa® (sofosbuvir + velpatasvir) HCV genotype 2 trials

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosis
      (% of patients)      		SVR at 12 weeks
      (cure)      		Other
      Epclusa® once daily for 12 weeksN=104
      (ASTRAL-1)      		24%10%100% (104/104)
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Ribavirin dosing was weight-based: < 165 lbs (75 kg) - 1000 mg a day;
        ≥ 165 lbs (75 kg) - 1200 mg a day; ribavirin is given in 2 divided doses
      • In ASTRAL-4, 90% of the patients had Child-Pugh Class B liver failure
      Epclusa® once daily for 12 weeksN=134
      (ASTRAL-2)      		14%14%99% (133/134)
      Epclusa® once daily for 12 weeksN=4
      (ASTRAL-4)      		?100%100% (4/4)
      Epclusa® once daily + ribavirin for 12 weeksN=4
      (ASTRAL-4)      		?100%100% (4/4)
      Epclusa® once daily for 24 weeksN=4
      (ASTRAL-4)      		?100%75% (3/4)


    • Sofosbuvir (Sovaldi®) + ribavirin treatment regimens for HCV genotype 2

      • See sofosbuvir and ribavirin for more
      • Weight-based ribavirin: < 165 lbs (75 kg) - 1000 mg a day; > 165 lbs (75 kg) - 1200 mg a day; ribavirin is given in 2 divided doses
      HCV genotype 2 treatment
      Reference - Sofosbuvir PI
      Treatment historyRegimenDuration
      Treatment-naïve and previous treatmentSofosbuvir 400 mg once daily + weight-based ribavirin12 weeks

    • Sofosbuvir (Sovaldi®) + ribavirin HCV genotype 2 trials

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosis
      (% of patients)      		SVR at 12 weeks
      (cure)      		Other
      Sofosbuvir 400 mg once daily + weight-based ribavirin for 12 weeksN=73
      (FISSION)      		NO16%No cirrhosis - 97%
      Cirrhosis - 83%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Weight-based ribavirin: < 165 lbs (75 kg) - 1000 mg a day; > 165 lbs (75 kg) - 1200 mg a day
      Sofosbuvir 400 mg once daily + weight-based ribavirin for 12 weeksN=39
      (FUSION)      		YES26%No cirrhosis - 90%
      Cirrhosis - 60%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Previous treatment was failure with an interferon-based regimen
      • Weight-based ribavirin: < 165 lbs (75 kg) - 1000 mg a day; > 165 lbs (75 kg) - 1200 mg a day
      Sofosbuvir 400 mg once daily + weight-based ribavirin for 12 weeksN=109
      (POSITRON)      		PegIFN intolerant,
      ineligible, or unwilling      		16%No cirrhosis - 92%
      Cirrhosis - 94%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Weight-based ribavirin: < 165 lbs (75 kg) - 1000 mg a day; > 165 lbs (75 kg) - 1200 mg a day


  • GENOTYPE 3

    • Epclusa® (sofosbuvir + velpatasvir) treatment regimens for HCV genotype 3

      • Ribavirin dosing is weight-based: < 165 lbs (75 kg) - 1000 mg a day; ≥ 165 lbs (75 kg) - 1200 mg a day; ribavirin is given in 2 divided doses
      • Epclusa = velpatasvir 100 mg + sofosbuvir 400 mg
      HCV genotype 3 treatment
      Reference - Epclusa® PI
      Patient populationRegimenDuration
      Patients without cirrhosis and patients with
      compensated cirrhosis (Child-Pugh A)      		Epclusa® once daily12 weeks
      Patients with decompensated
      cirrhosis (Child-Pugh B/C)      		Epclusa® once daily + ribavirin12 weeks

    • Epclusa® (sofosbuvir + velpatasvir) HCV genotype 3 trials

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosis
      (% of patients)      		SVR at 12 weeks
      (cure)      		Other
      Epclusa® once daily for 12 weeksN=277
      (ASTRAL-3)      		26%29%95% (264/277)
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Ribavirin dosing was weight-based: < 165 lbs (75 kg) - 1000 mg a day;
        ≥ 165 lbs (75 kg) - 1200 mg a day; ribavirin is given in 2 divided doses
      • In ASTRAL-4, 90% of the patients had Child-Pugh Class B liver failure
      Epclusa® once daily for 12 weeksN=14
      (ASTRAL-4)      		?100%50% (7/14)
      Epclusa® once daily + ribavirin for 12 weeksN=13
      (ASTRAL-4)      		?100%85% (11/13)
      Epclusa® once daily for 24 weeksN=12
      (ASTRAL-4)      		?100%50% (6/12)


    • Sofosbuvir (Sovaldi®) + daclatasvir (Daklinza™) treatment regimens for HCV genotype 3

      • *Ribavirin dosing in Child-Pugh A: < 165 lbs (75 kg) - 1000 mg a day; > 165 lbs (75 kg) - 1200 mg a day; ribavirin is given in 2 divided doses
      • *Ribavirin dosing in Child-Pugh B and C: start with 600 mg once daily and increase to 1000 mg/day as tolerated
      • See sofosbuvir, daclatasvir, and ribavirin for more
      HCV genotype 3 treatment
      Reference - Daklinza PI
      Patient populationRegimenDuration
      Without cirrhosisSofosbuvir 400 mg once daily + daclatasvir 60 mg once daily12 weeks
      With cirrhosis (Child-Pugh A,B, and C) or
      Post-liver transplant      		Sofosbuvir 400 mg once daily + daclatasvir 60 mg once daily
      + ribavirin*      		12 weeks

    • Sofosbuvir + daclatasvir HCV genotype 3 trials

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosis
      (% of patients)      		SVR at 12 weeks
      (cure)      		Other
      Sofosbuvir 400 mg once daily +
      daclatasvir 60 mg once daily
      for 12 weeks      		N=152
      (ALLY-3)      		NO - 66%
      YES - 33%      		21%No cirrhosis (treatment-naïve) - 98% (80/82)
      No cirrhosis (previous treatment failure) - 92% (35/38)
      Cirrhosis (treatment-naïve) - 58% (11/19)
      Cirrhosis (previous treatment failure) - 69% (9/13)
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Previous treatment included any type of HCV treatment (PegIFN, ribavirin, sofosbuvir, etc.)
      • See sofosbuvir and daclatasvir for more
      Sofosbuvir 400 mg once daily +
      daclatasvir 60 mg once daily +
      weight-based ribavirin
      for 12 weeks      		N=24
      (ALLY-3+)      		NO - 25%
      YES - 75%      		75%No cirrhosis - 100% (6/6)
      Cirrhosis (all) - 83% (15/18)
      Cirrhosis (previous treatment failure) - 88% (14/16)
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Previous treatment included interferon-based and sofosbuvir-based regimens
      • Weight-based ribavirin: < 165 lbs (75 kg) - 1000 mg a day; > 165 lbs (75 kg) - 1200 mg a day
      • See sofosbuvir and daclatasvir for more
      Sofosbuvir 400 mg once daily +
      daclatasvir 60 mg once daily +
      weight-based ribavirin
      for 16 weeks      		N=26
      (ALLY-3+)      		NO - 27%
      YES - 73%      		69%No cirrhosis - 100% (8/8)
      Cirrhosis (all) - 89% (16/18)
      Cirrhosis (previous treatment failure) - 86% (12/14)


    • Sofosbuvir (Sovaldi®) + ribavirin treatment regimens for HCV genotype 3

      • See sofosbuvir and ribavirin for more
      • Weight-based ribavirin: < 165 lbs (75 kg) - 1000 mg a day; > 165 lbs (75 kg) - 1200 mg a day; ribavirin is given in 2 divided doses
      HCV genotype 3 treatment
      Reference - Sofosbuvir PI
      Patient populationRegimenDuration
      Treatment-naïve, relapsers, and treatment failuresSofosbuvir 400 mg once daily + weight-based ribavirin24 weeks

    • Sofosbuvir (Sovaldi®) + ribavirin HCV genotype 3 trials

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosis
      (% of patients)      		SVR at 12 weeks
      (cure)      		Other
      Sofosbuvir 400 mg once daily + weight-based ribavirin
      for 24 weeks      		N=250
      (VALENCE)      		NO - 42%
      YES - 58%      		24%No cirrhosis (treatment-naïve) - 93%
      No cirrhosis (previous treatment failure) - 85%
      Cirrhosis (treatment-naïve) - 92%
      Cirrhosis (previous treatment failure) - 60%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Previous treatment was with an interferon-based regimen
      • Weight-based ribavirin: < 165 lbs (75 kg) - 1000 mg a day; > 165 lbs (75 kg) - 1200 mg a day


  • GENOTYPE 4

    • Epclusa® (sofosbuvir + velpatasvir) treatment regimens for HCV genotype 4

      • Ribavirin dosing is weight-based: < 165 lbs (75 kg) - 1000 mg a day; ≥ 165 lbs (75 kg) - 1200 mg a day; ribavirin is given in 2 divided doses
      • Epclusa = velpatasvir 100 mg + sofosbuvir 400 mg
      HCV genotype 4 treatment
      Reference - Epclusa® PI
      Patient populationRegimenDuration
      Patients without cirrhosis and patients with
      compensated cirrhosis (Child-Pugh A)      		Epclusa® once daily12 weeks
      Patients with decompensated
      cirrhosis (Child-Pugh B/C)      		Epclusa® once daily + ribavirin12 weeks

    • Epclusa® (sofosbuvir + velpatasvir) HCV genotype 4 trials

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosis
      (% of patients)      		SVR at 12 weeks
      (cure)      		Other
      Epclusa® once daily for 12 weeksN=116
      (ASTRAL-1)      		45%23%100% (116/116)
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Ribavirin dosing was weight-based: < 165 lbs (75 kg) - 1000 mg a day;
        ≥ 165 lbs (75 kg) - 1200 mg a day; ribavirin is given in 2 divided doses
      • In ASTRAL-4, 90% of the patients had Child-Pugh Class B liver failure
      Epclusa® once daily for 12 weeksN=4
      (ASTRAL-4)      		?100%100% (4/4)
      Epclusa® once daily + ribavirin for 12 weeksN=2
      (ASTRAL-4)      		?100%100% (2/2)
      Epclusa® once daily for 24 weeksN=2
      (ASTRAL-4)      		?100%100% (2/2)


    • Harvoni™ (sofosbuvir + ledipasvir) treatment regimens for HCV genotype 4

      • Harvoni™ = ledipasvir 90 mg + sofosbuvir 400 mg
      • Treatment-experienced includes patients who failed PegIFN + ribavirin ± protease inhibitor regimens
      HCV genotype 4 treatment
      Reference - Harvoni™ PI
      Patient populationRegimenDuration
      Treatment-naïve, treatment-experienced
      with or without cirrhosis      		Harvoni™ once daily12 weeks

    • Harvoni™ (sofosbuvir + ledipasvir) HCV genotype 4 trials

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosisSVR at 12 weeks
      (cure)      		Other
      Harvoni™ once daily for 12 weeksN=52
      (2 combined studies)      		YES and NO,
      did not affect response      		YES and NO,
      did not affect response      		94%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Results are combined from ION-4 study and Study 1119 detailed in the PI
      • Harvoni™ = ledipasvir 90 mg + sofosbuvir 400 mg


    • Technivie™ ± ribavirin treatment regimens for HCV genotype 4

      • *Technivie without ribavirin may be considered in treatment-naïve patients without cirrhosis who cannot tolerate ribavirin
      • Technivie contains paritaprevir, ombitasvir, and ritonavir in one tablet. Technivie dosage is two tablets once daily.
      • Weight-based ribavirin: < 165 lbs (75 kg) - 1000 mg a day; > 165 lbs (75 kg) - 1200 mg a day; ribavirin is given in 2 divided doses
      • Treatment failure - patients who failed previous PegIFN + ribavirin therapy
      HCV genotype 4 treatment
      Reference - Technivie PI
      Patient populationRegimenDuration
      Treatment-naïve and treatment failure
      without cirrhosis or with compensated cirrhosis      		Technivie + weight-based ribavirin12 weeks
      Treatment-naïve without cirrhosis*Technivie12 weeks

    • Technivie™ ± ribavirin HCV genotype 4 trials

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosis
      (% of patients)      		SVR at 12 weeks
      (cure)      		Other
      Technivie for 12 weeksN=44
      (PEARL-I GT4)      		NO0%91%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Technivie contains paritaprevir, ombitasvir, and ritonavir in one tablet. Technivie dosage is two tablets once daily.
      Technivie + weight-based ribavirin
      for 12 weeks      		N=42
      (PEARL-I GT4)      		NO0%100%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Weight-based ribavirin: < 165 lbs (75 kg) - 1000 mg a day; > 165 lbs (75 kg) - 1200 mg a day
      • Technivie contains paritaprevir, ombitasvir, and ritonavir in one tablet. Technivie dosage is two tablets once daily.
      Technivie + weight-based ribavirin
      for 12 weeks      		N=49
      (PEARL-I GT4)      		YES0%100%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Weight-based ribavirin: < 165 lbs (75 kg) - 1000 mg a day; > 165 lbs (75 kg) - 1200 mg a day
      • Previous treatment with ribavirin + PegIFN
      • Technivie contains paritaprevir, ombitasvir, and ritonavir in one tablet. Technivie dosage is two tablets once daily.


    • Zepatier™ (elbasvir + grazoprevir) treatment regimens for HCV genotype 4

      • PegIFN = pegylated interferon
      • Zepatier = elbasvir 50 mg + grazoprevir 100 mg
      • Ribavirin dosing is weight-based: < 66 kg (145 pounds) - 800 mg per day; 66 - 80 kg (145 - 176 pounds) - 1000 mg per day;
        81 - 105 kg (177 - 231 pounds) - 1200 mg per day; > 105 kg (231 pounds) - 1400 mg per day
      HCV genotype 4 treatment
      Reference - Zepatier PI
      Treatment historyRegimen
      Treatment-naïveZepatier for 12 weeks
      PegIFN/ribavirinZepatier + ribavirin for 16 weeks

    • Zepatier™ HCV genotype 4 trials

      • Regimen# of patients
      (study)      		Previous treatmentSVR at 12 weeks
      (cure)      		Other
      Zepatier™
      for 12 weeks      		N=66
      (combined)      		NO97% (64/66)
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • Ribavirin dosing was weight-based: < 66 kg (145 pounds) - 800 mg per day; 66 - 80 kg (145 - 176 pounds) - 1000 mg per day;
        81 - 105 kg (177 - 231 pounds) - 1200 mg per day; > 105 kg (231 pounds) - 1400 mg per day
      Zepatier™ + ribavirin
      for 16 weeks      		N=8
      (combined)      		YES100% (8/8)


  • SOFOSBUVIR FAILURES

    • Genotype 1

      • Weight-based ribavirin: < 165 lbs (75 kg) - 1000 mg a day; > 165 lbs (75 kg) - 1200 mg a day; ribavirin is given in 2 divided doses
      Treatment in patients who failed previous sofosbuvir + ribavirin ± PegIFN
      Reference - sofosbuvir failure trials
      Patient populationRegimenDuration
      Treatment failure with
      sofosbuvir + ribavirin ± PegIFN      		Ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni™) + weight-based ribavirin12 weeks
      Treatment failure with
      sofosbuvir + ribavirin for 24 weeks      		Ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni™)12 weeks

    • HCV genotype 1 trials in patients who failed previous sofosbuvir + ribavirin ± PegIFN

      • Regimen# of patients
      (study)      		Previous treatmentCirrhosis
      (% of patients)      		SVR at 12 weeks
      (cure)      		Other
      Ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni™) once daily
      + weight-based ribavirin for 12 weeks      		N=51
      (Sofosbuvir-failure
      trial      )      		100%
      (49% Sof/Rib/PegIFN)
      (39% Sof/Rib)
      (10% Rib/PegIFN)      		27%98%
      (50/51)
      • NOTE: the one treatment failure actually had Genotype 3 and was included by error
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      Ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni™)
      once daily for 12 weeks      		N=14
      (Sofosbuvir-failure
      trial)      		YES
      all patients had failed
      24 weeks of Sof + ribavirin      		50%, did not
      affect response      		100%
      • SVR - sustained virological response 12 weeks after treatment ended (cure)
      • All patients had previously failed sofosbuvir + ribavirin for 24 weeks


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