Genotype 1

  1. G1a naïve NON-CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 96% SVR12 (ION-3) to 98% SVR12 (ION-1)
    2. *Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 8 weeks [If Baseline HCV RNA <6 million IU/mL] –> 93% SVR12 (ION-3)
    3. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 98% SVR12 (ASTRAL-1)
    4. SOF 400mg QD + SMV 150mg QD [with food] for 12 weeks –> 95% SVR12 (COSMOS [Pooled Analysis] – F0-3) and 97% SVR12 [OPTIMIST-1]
    5. Viekira Pak [Paritaprevir/r + Ombitasvir daily fixed dose combination + Dasabuvir twice daily dose + RBV WBD [BID] [with food] for 12 weeks –> 96% SVR12 (Sapphire I) to 97% SVR12 [Pearl IV]
    6. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks [If NO baseline NS5A RAVs for Elbasvir] –> 95% SVR12 (C-EDGE)
    7. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily + RBV WBD BID [with food] for 16 weeks [If [+] baseline high-fold change NS5A RAVs for Elbasvir]  –> 100% SVR12 (C-EDGE – based on extrapolation of data from the C-EDGE TE trial)
    8. SOF 400MG QD + DCV 60 MG QD for 12 weeks –> 96% SVR12 (ALLY-2)

 

  1. G1a naïve COMPENSATED CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 94% SVR12 (ION-1)
    2. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 99% SVR12 (ASTRAL-1)
    3. SOF 400mg QD + SMV 150mg QD [with food] for 24 weeks –> 100% SVR12 (COSMOS [Pooled Analysis] F4 ) and 12 weeks –> 84% SVR12 [OPTIMIST-2; No Q80K mutation]
    4. Viekira Pak [Paritaprevir/r + Ombitasvir daily fixed dose combination + Dasabuvir twice daily dose + RBV WBD BID] [with food] for 24 weeks –> 95% SVR12 (Turquoise II)
    5. *Viekira Pak [Paritaprevir/r + Ombitasvir daily fixed dose combination + Dasabuvir twice daily dose + RBV WBD BID] [with food] for 12 weeks –> 92% SVR12 (Turquoise II)
    6. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks [If NO baseline NS5A RAVs for Elbasvir] –> 97% SVR12 (C-EDGE and C-WORTHY)
    7. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily + RBV WBD BID [with food] for 16 weeks [If [+] baseline high-fold change NS5A RAVs for Elbasvir]  –> ?% SVR12 (C-EDGE – based on extrapolation of data from the C-EDGE TE trial)
    8. SOF 400MG QD + DCV 60 MG QD +/- RBV WBD BID for 24 weeks –> ?% SVR12 (Compassionate Use European Program)

 

  1. G1b naïve NON-CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 98% SVR12 (ION-3) to 100% SVR12 (ION-1)
    2. *Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 8 weeks [If Baseline HCV RNA <6 million IU/mL] –> 98% SVR12 (ION-3)
    3. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 99% SVR12 (ASTRAL-1)
    4. SOF 400mg QD + SMV 150mg QD [with food] for 12 weeks –> 95% SVR12 (COSMOS [Pooled Analysis] – F0-3) and 97% SVR12 [OPTIMIST-1]
    5. Viekira Pak [Paritaprevir/r + Ombitasvir daily fixed dose combination + Dasabuvir twice daily dose] [with food] for 12 weeks –> 98% SVR12 (Sapphire I) to 100% SVR12 [Pearl III]
    6. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks –> 99% SVR12 (C-EDGE and C-WORTHY)
    7. SOF 400MG QD + DCV 60 MG QD for 12 weeks –> 100% SVR12 (ALLY-2)

 

  1. G1b naïve COMPENSATED CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 94% to 100% SVR12 (ION-1)
    2. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 99% SVR12 (ASTRAL-1)
    3. SOF 400mg QD + SMV 150mg QD [with food] for 24 weeks –> 100% SVR12 (COSMOS [Pooled Analysis] F4 ) and 12 weeks –> 92% SVR12 [OPTIMIST-2]
    4. Viekira Pak [Paritaprevir/r + Ombitasvir daily fixed dose combination + Dasabuvir twice daily dose 12 weeks –> 100% SVR12 (Turquoise III)
    5. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks –> 99% SVR12 (C-EDGE and C-WORTHY)
    6. SOF 400MG QD + DCV 60 MG QD +/- RBV WBD BID for 24 weeks –> ?% SVR12 (Compassionate Use European Program)
  2. G1a prior treatment failure to PEG + RBV NON-CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 95% SVR12 (ION-2)
    2. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 24 weeks –> 99% SVR12 (ION-2)
    3. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 100% SVR12 (ASTRAL-1)
    4. SOF 400mg QD + SMV 150mg QD [with food] for 12 weeks –> 95% SVR12 (COSMOS [Pooled Analysis] – F0-3)
    5. Viekira Pak [Paritaprevir/r + Ombitasvir daily fixed dose combination + Dasabuvir twice daily dose + RBV WBD [BID] [with food] for 12 weeks –> 94-100% SVR12 (Sapphire II)
    6. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks [If NO baseline NS5A RAVs for Elbasvir] –> 90% SVR12 (C-EDGE)
    7. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily + RBV WBD BID [with food] for 16 weeks [If [+] baseline high-fold change NS5A RAVs for Elbasvir]  –> 95% SVR12 (C-EDGE)

 

  1. G1a prior treatment failure to PEG + RBV COMPENSATED CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 95% SVR12 (ION-2)
    2. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily + RBV WBD [BID] for 12 weeks –> 96% SVR12 (Hepatology 2014;60:239A)
    3. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 24 weeks –> 99% SVR12 (ION-2)
    4. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 100% SVR12 (ASTRAL-1)
    5. SOF 400mg QD + SMV 150mg QD [with food] for 24 weeks –> 100% SVR12 (COSMOS [Pooled Analysis] F4 ) [TEST FOR PRESENCE OF Q80K POLYMORPHISM – IF DETECTED – ALTERNATIVE TREATMENT SHOULD BE CONSIDERED (OPTIMIST-2)]
    6. Viekira Pak [Paritaprevir/r + Ombitasvir daily fixed dose combination + Dasabuvir twice daily dose + RBV WBD [BID] [with food] for 24 weeks –> 93-100% SVR12 (Turquoise II)
    7. *Viekira Pak [Paritaprevir/r + Ombitasvir daily fixed dose combination + Dasabuvir twice daily dose + RBV WBD [BID] [with food] for 12 weeks –> 93-100% SVR12 (Turquoise II) – only for prior partial responders and prior relapse [NOT PRIOR NULL RESPONDER – 80% SVR12 – NEED 24 WEEKS – 93% SVR12]
    8. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks [If NO baseline NS5A RAVs for Elbasvir] –> 94% SVR12 (C-EDGE and C-WORTHY)
    9. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily + RBV WBD BID [with food] for 16 weeks [If [+] baseline high-fold change NS5A RAVs for Elbasvir]  –> 100% SVR12 (C-EDGE)

 

  1. G1b prior treatment failure to PEG + RBV NON-CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 95% SVR12 (ION-2)
    2. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 24 weeks –> 99% SVR12 (ION-2)
    3. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 97% SVR12 (ASTRAL-1)
    4. SOF 400mg QD + SMV 150mg QD [with food] for 12 weeks –> 95% SVR12 (COSMOS [Pooled Analysis] – F0-3)
    5. Viekira Pak [Paritaprevir/r + Ombitasvir daily fixed dose combination + Dasabuvir twice daily dose + RBV WBD [BID] [with food] for 12 weeks –> 94-100% SVR12 (Sapphire II)
    6. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks –> 100% SVR12 (C-EDGE)

 

  1. G1b prior treatment failure to PEG + RBV COMPENSATED CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 95% SVR12 (ION-2)
    2. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily + RBV WBD [BID] for 12 weeks –> 96% SVR12 (Hepatology 2014;60:239A)
    3. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 24 weeks –> 99% SVR12 (ION-2)
    4. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 97% SVR12 (ASTRAL-1)

 

  1. SOF 400mg QD + SMV 150mg QD [with food] for 24 weeks –> 100% SVR12 (COSMOS [Pooled Analysis] F4 )
  2. Viekira Pak [Paritaprevir/r + Ombitasvir daily fixed dose combination + Dasabuvir twice daily dose + RBV WBD [BID] [with food] for 12 weeks –> 93-100% SVR12 (Turquoise II)
  3. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks –> 100% SVR12 (C-EDGE)

 

  1. G1a/1b prior treatment failure to PEG + RBV + PI NON-CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 96% SVR12 (ION-2)
    2. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 24 weeks –> 97% SVR12 (ION-2)
    3. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 100% SVR12 (ASTRAL-1)

 

  1. G1a/1b prior treatment failure to PEG + RBV + SOF or SOF + RBV NON-CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily+ RBV WBD [BID] for 12 weeks –> 100% SVR12 (Wyles, Hepatology 2015b)

 

  1. G1a/1b prior treatment failure to PEG + RBV + PI COMPENSATED CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 24 weeks –> 100% SVR12 (ION-2) & 97% SVR12 (Bourliere, Hepatology 2014a)
    2. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily + RBV WBD [BID] for 12 weeks –> 96% SVR12 (SIRIUS) & (Bourliere, Hepatology 2014a)
    3. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks –> 100% SVR12 (ASTRAL-1)

 

  1. G1a/1b prior treatment failure to PEG + RBV + SOF or SOF + RBV COMPENSATED CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily+ RBV WBD [BID] for 24 weeks –> 95-98% SVR12 (Reddy, Hepatology 2015)

 

 

  1. G1a/1b prior treatment failure to SOF + SMV  NON-CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily+ RBV WBD [BID] for 12 weeks –> ?% SVR12

 

  1. G1a/1b prior treatment failure to SOF + SMV COMPENSATED CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily + RBV WBD [BID] for 24 weeks –> ?% SVR12 (NO NS5A RAVS DETECTED)
    2. SOF 400mg QD + SMV 150mg QD + RBV WBD [BID] [with food] for 24 weeks –> ?% SVR12 (NO NS3 RAVS DETECTED + NS5A RAVS DETECTED)

 

  1. G1a/1b prior treatment failure to HARVONI [8 OR 12 WEEKS PRIOR TREATMENT] with OR without COMPENSATED CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 24 weeks –> 100% SVR12 (NO NS5A RAVS DETECTED) and 60% SVR12 [NS5A RAVS DETECTED] (Lawitz, EASL 2015]
    2. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily + RBV WBD [BID] [with food] for 24 weeks –> 97% SVR12 (Ganes EASL 2016) (Baseline NS5A RAVs did not appear to effect SVR rates)

 

  1. G1a/1b DECOMPENSATED CIRRHOTIC [CTP CLASS B OR C]
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily + RBV [INITIAL DOSE OF 600 MG DAILY, INCREASED AS TOLERATED] for 12 weeks –> 87% SVR12 (SOLAR-2)
    2. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 24 weeks –> 89% SVR12 (SOLAR-2) [ANEMIA + RBV INTOLERANCE]
    3. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily + RBV [INITIAL DOSE OF 600 MG DAILY, INCREASED AS TOLERATED] for 24 weeks –> ?% SVR12 [PRIOR SOF BASED TREATMENT FAILURE]
    4. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily + RBV WBD [BID] [with food] for 12 weeks –> 96% SVR12 (ASTRAL-4)
    5. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 24 weeks –> 92% SVR12 (ASTRAL-4) [ANEMIA + RBV INTOLERANCE]
    6. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily + RBV WBD [BID] [with food] [Low Dose 600 mg Daily for CTP Class C] for 24 weeks –> ?% SVR12 [PRIOR SOF or NS5A BASED TREATMENT FAILURE]
    7. SOF 400MG QD + DCV 60 MG QD + RBV [INITIAL DOSE OF 600 MG DAILY, INCREASED AS TOLERATED] for 12 weeks –> 83% SVR12 (ALLY-1) [94% in CTP Class B & 56% in CTP Class C]
    8. SOF 400MG QD + DCV 60 MG QD for 24 weeks –> ?% SVR12 [ANEMIA + RBV INTOLERANCE]

 

  1. G1a/1b RENAL IMPAIRMENT [CrCl <30 mL/min & ESRD with HD] NON- CIRRHOTIC
    1. Viekira Pak [Paritaprevir/r + Ombitasvir daily fixed dose combination + Dasabuvir twice daily dose + RBV [with food] for 12-24 weeks –> 100% SVR4 (RUBY-1 Pockros, EASL 2015) [RENAL BASED DOSE OF RBV 200 MG DAILY]
    2. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks –> 94% SVR12 [G1a 97%; G1b 92%] [TN 95%; TE 90%] [Dialysis – No 97%; Yes 93%] (C-SURFER)

SOF = Sofosbuvir [Sovaldi] [400 mg daily] – NS5B nucleotide analog polymerase inhibitor

SMV = Simeprevir [OlysioTM] [150 mg daily] – NS3/4A protease inhibitor – taken with food

RBV = Ribavirin [RIBAPAK/MODERIBA/RIBAVIRIN] [Weight <75 kg – 1000 mg daily; >75 kg – 1200 mg daily]

LDV = Ledipasvir [90 mg daily] – NS5A inhibitor

VEL = Velpatasvir [100 mg daily] – NS5A inhibitor

Viekira Pak = Paritaprevir [150 mg]/r [100 mg] (NS3/4A protease inhibitor + ritonavir) + Ombitasvir [25 mg] (NS5A inhibitor) + Dasabuvir [250 mg] (non-nucleoside NS5B polymerase inhibitor) ± RBV WBD

DCV = Daclatasvir [60 mg daily] [DAKLINZA] – NS5A inhibitor

Zepatier = Elbasvir [50 mg] – NS5A inhibitor + Grazoprevir [100 mg daily] – NS3/4A protease inhibitor

RAVS = Resistance Associated Variants [Blood Test]

**RBV IS RECOMMENDED AS PART OF ALL RETREATMENT REGIMENS FOR PATIENTS IN WHOM PRIOR TREATMENT WITH NS5A INHIBITORS HAS FAILED [ASSLD 2015]

 

Regimen & Duration By Patient Type                                                                                   

PATIENT POPULATION REGIMEN DURATION [weeks]
G1

Treatment naïve without cirrhosis & pre-treatment HCV RNA <6 million IU/ml

HARVONI 8
G1

Treatment naïve with or without cirrhosis

HARVONI

HARVONI + RBV [Decompensated Cirrhosis]

12
G1

Treatment experienced without cirrhosis

HARVONI 12
G1

Treatment experienced with cirrhosis

HARVONI 24
G1

Treatment naïve or experienced without cirrhosis

OLYSIO + SOFOSBUVIR 12
G1

Treatment naïve or experienced with cirrhosis

OLYSIO + SOFOSBUVIR 24
G1a

Treatment naïve or experienced without cirrhosis

VIEKIRA PAK + RBV 12
     
     
PATIENT POPULATION REGIMEN DURATION [weeks]
G1a

Treatment naïve or experienced [partial responder and relapse] with cirrhosis

VIEKIRA PAK + RBV 12
G1a

Treatment experienced [null responder] with compensated cirrhosis

VIEKIRA PAK + RBV 24
G1b

Treatment naïve or experienced without cirrhosis

VIEKIRA PAK 12
G1b

Treatment naïve or experienced with compensated cirrhosis

VIEKIRA PAK 12
G1a

Treatment naïve or experienced [PegIFN/RBV] without or with cirrhosis [No Baseline NS5A Polymorphisms]

ZEPATIER 12
G1a

Treatment naïve or experienced[PegIFN/RBV]   without or with cirrhosis [Yes Baseline NS5A  Polymorphisms]

ZEPATIER + RBV 16
G1b

Treatment naïve or experienced [PegIFN/RBV]    without or with cirrhosis

ZEPATIER 12
G1a or G1b

PegIFN/RBV/PI Experienced without or with cirrhosis [G1a No Baseline NS5A Polymorphisms  ] 

ZEPATIER + RBV 12
G1a

PegIFN/RBV/PI Experienced without or with cirrhosis

[Yes Baseline NS5A Polymorphisms  ] 

ZEPATIER + RBV UNKNOWN
G1

Treatment naive with or without compensated cirrhosis

EPCLUSA 12
G1

Treatment experienced with or without compensated cirrhosis

EPCLUSA 12
G1

Decompensated cirrhosis

EPCLUSA + RBV 12


 

 

 

Clinic Visits & Labs                                                                                                                      

  1. Initiation of Therapy
  2. Week 2 – CBC, CMP
  3. Week 4 – CBC, CMP, HCV RNA PCR quantitative [hCG with RBV]
  4. Week 8 – CBC, CMP
  5. Week 12 – CBC, CMP, HCV RNA PCR quantitative [hCG with RBV]
  6. Week 4 Post Therapy – CBC, CMP, HCV RNA PCR quantitative [hCG with RBV]
  7. Week 12 Post Therapy – CBC, CMP, HCV RNA PCR quantitative [hCG with RBV] – SVR12

*** 24 weeks duration therapy

  • Monthly labs after week 12 – CBC & CMP
  • Week 24 HCV RNA PCR quantitative [hCG with RBV]

 

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