Genotype 1

  1. G1a naïve NON-CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 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, non-black, and non-HIV +] à 95% SVR12 (ION-3) [SEE INFORMATION BELOW]
    3. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 98% SVR12 (ASTRAL-1)
    4. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks [If NO baseline NS5A RAS for Elbasvir] à 95% SVR12 (C-EDGE)
    5. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily + RBV WBD BID [with food] for 16 weeks [If [+] baseline high-fold change NS5A RAS for Elbasvir] à 100% SVR12 (C-EDGE – based on extrapolation of data from the C-EDGE TE trial)
    6. Mavyret [Glecaprevir and Pibrentasvir 3-tablet coformulation] 3 tabs daily [with food] for 8 weeks à 99% SVR12 (ENDURANCE-1)

 

  1. G1a naïve COMPENSATED CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 94% SVR12 (ION-1)
    2. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 99% SVR12 (ASTRAL-1)
    3. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks [If NO baseline NS5A RAS for Elbasvir] à 97% SVR12 (C-EDGE and C-WORTHY)
    4. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily + RBV WBD BID [with food] for 16 weeks [If [+] baseline high-fold change NS5A RAS for Elbasvir] à ?% SVR12 (C-EDGE – based on extrapolation of data from the C-EDGE TE trial)
    5. Mavyret [Glecaprevir and Pibrentasvir 3-tablet coformulation] 3 tabs daily [with food] for 12 weeks à 99% SVR12 (EXPEDITION-1) AND 98% SVR12 (EXPEDITION-2)

 

  1. G1b naïve NON-CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 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, non-black, and non-HIV +] à 98% SVR12 (ION-3) [SEE INFORMATION BELOW]
    3. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 99% SVR12 (ASTRAL-1)
    4. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks à 99% SVR12 (C-EDGE and C-WORTHY)
    5. Mavyret [Glecaprevir and Pibrentasvir 3-tablet coformulation] 3 tabs daily [with food] for 8 weeks à 99% SVR12 (ENDURANCE-1)

 

  1. G1b naïve COMPENSATED CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 94% to 100% SVR12 (ION-1)
    2. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 99% SVR12 (ASTRAL-1)
    3. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks à 99% SVR12 (C-EDGE and C-WORTHY)
    4. Mavyret [Glecaprevir and Pibrentasvir 3-tablet coformulation] 3 tabs daily [with food] for 12 weeks à 99% SVR12 (EXPEDITION-1) AND 98% SVR12 (EXPEDITION-2)

 

  1. G1a prior treatment failure to PEG + RBV NON-CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 95% SVR12 (ION-2)
    2. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 24 weeks à 99% SVR12 (ION-2)
    3. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 100% SVR12 (ASTRAL-1)
    4. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks [If NO baseline NS5A RAS for Elbasvir] à 90% SVR12 (C-EDGE)
    5. Mavyret [Glecaprevir and Pibrentasvir 3-tablet coformulation] 3 tabs daily [with food] for 8 weeks à 99% SVR12 (ENDURANCE-1)

 

  1. G1a prior treatment failure to PEG + RBV COMPENSATED CIRRHOTIC
    1. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 100% SVR12 (ASTRAL-1)
    2. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks [If NO baseline NS5A RAVs for Elbasvir] à 94% SVR12 (C-EDGE and C-WORTHY)
    3. Mavyret [Glecaprevir and Pibrentasvir 3-tablet coformulation] 3 tabs daily [with food] for 12 weeks à 99% SVR12 (EXPEDITION-1)

 

  1. G1b prior treatment failure to PEG + RBV NON-CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 95% SVR12 (ION-2)
    2. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 97% SVR12 (ASTRAL-1)
    3. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks à 100% SVR12 (C-EDGE)
    4. Mavyret [Glecaprevir and Pibrentasvir 3-tablet coformulation] 3 tabs daily [with food] for 8 weeks à 99% SVR12 (ENDURANCE-1)

 

  1. G1b prior treatment failure to PEG + RBV COMPENSATED CIRRHOTIC
    1. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 97% SVR12 (ASTRAL-1)
    2. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks à 100% SVR12 (C-EDGE)
    3. Mavyret [Glecaprevir and Pibrentasvir 3-tablet coformulation] 3 tabs daily [with food] for 12 weeks à 99% SVR12 (EXPEDITION-1)

 

  1. G1a/1b prior treatment failure to PEG + RBV + PI (Telaprevir, Boceprevir, or Simeprevir) NON-CIRRHOTIC
    1. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 96% SVR12 (ION-2)
    2. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 100% SVR12 (ASTRAL-1)
    3. Mavyret [Glecaprevir and Pibrentasvir 3-tablet coformulation] 3 tabs daily [with food] for 12 weeks à 92% SVR12 (MAGELLAN-1)

 

  1. G1a/1b prior treatment failure to PEG + RBV + SOF or SOF + RBV NON-CIRRHOTIC (NON-NS5A INHIBITOR)
    1. Vosevi [VEL/SOF/VOX daily fixed dose combination] 1 tab daily for 12 weeks à 97% SVR12 (POLARIS-4) – Genotype 1a
    2. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 95% SVR12 (POLARIS-4) – Genotype 1b
    3. Mavyret [Glecaprevir and Pibrentasvir 3-tablet coformulation] 3 tabs daily [with food] for 12 weeks à 92% SVR12 (MAGELLAN-1)

 

  1. G1a/1b prior treatment failure to PEG + RBV + PI (Telaprevir, Boceprevir, or Simeprevir) COMPENSATED CIRRHOTIC
    1. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 100% SVR12 (ASTRAL-1)
    2. Mavyret [Glecaprevir and Pibrentasvir 3-tablet coformulation] 3 tabs daily [with food] for 12 weeks à 92% SVR12 (MAGELLAN-1)

 

  1. G1a/1b prior treatment failure to PEG + RBV + SOF or SOF + RBV COMPENSATED CIRRHOTIC (NON-NS5A INHIBITOR)
    1. Vosevi [VEL/SOF/VOX daily fixed dose combination] 1 tab daily for 12 weeks à 97% SVR12 (POLARIS-4) – Genotype 1a
    2. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 12 weeks à 95% SVR12 (POLARIS-4) – Genotype 1b
    3. Mavyret [Glecaprevir and Pibrentasvir 3-tablet coformulation] 3 tabs daily [with food] for 12 weeks à 99% SVR12 (EXPEDITION-1)

 

  1. G1a/1b prior treatment failure to NS5A-INHIBITOR NON-CIRRHOTIC OR COMPENSATED CIRRHOTIC
    1. Vosevi [VEL/SOF/VOX daily fixed dose combination] 1 tab daily for 12 weeks à 96% SVR12 [Genotype 1a] and 100% [Genotype 1b] (POLARIS-1)

 

  1. G1a/1b DECOMPENSATED CIRRHOTIC [CTP CLASS B OR C]
    1. Harvoni [LDV/SOF daily fixed dose combination] 1tab daily + RBV [INITIAL DOSE OF 600 MG DAILY, INCREASED AS TOLERATED] for 12 weeks à 87% SVR12 (SOLAR-2)
    2. Harvoni [LDV/SOF daily fixed dose combination] 1 tab daily for 24 weeks à 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 à ?% 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 à 96% SVR12 (ASTRAL-4)
    5. Epclusa [VEL/SOF daily fixed dose combination] 1 tab daily for 24 weeks à 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 à ?% 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 à 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 à ?% SVR12 [ANEMIA + RBV INTOLERANCE]

 

  1. G1a/1b RENAL IMPAIRMENT [CrCl <30 mL/min & ESRD with HD] NON- CIRRHOTIC
    1. Zepatier [Elbasvir and Grazoprevir fixed dose combination] 1 tab daily for 12 weeks à 94% SVR12 [G1a 97%; G1b 92%] [TN 95%; TE 90%] [Dialysis – No 97%; Yes 93%] (C-SURFER)
    2. Mavyret [Glecaprevir and Pibrentasvir 3-tablet coformulation] 3 tabs daily [with food] for 12 weeks à 98% SVR12 (EXPEDITION-4)

 

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

LDV = Ledipasvir [90 mg daily] – NS5A inhibitor

DCV = Daclatasvir [60 mg daily] – NS5A inhibitor

VEL = Velpatasvir [100 mg daily] – NS5A inhibitor

VOX = Voxilaprevir [100mg] NS3/4A protease inhibitor

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

Vosevi = Sofosbuvir [400 mg] + Velpatasvir [100 mg] + Voxilaprevir [100mg] NS3/4A protease inhibitor

Mavyret = Glecaprevir [300 mg] – NS3/4A protease inhibitor + Pibrentasvir [120 mg] – – NS5A inhibitor

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

RAS = Resistance Associated Substitutions [Blood Test]

 

Harvoni = Ledipasvir/Sofosbuvir

Published, real-world cohort data generally show comparable effectiveness of 8-week and 12-week courses of ledipasvir/sofosbuvir in treatment-naive patients without cirrhosis (Backus, 2016); (Ingiliz, 2016); (Ioannou, 2016); (Kowdley, 2016); (Terrault, 2016). However, only about half of patients eligible for 8 weeks of treatment received it, assignment of duration was not randomized, and baseline characteristics may have varied between 8- and 12-week groups.

Based on available data, shortening treatment to less than 12 weeks is not recommended for HIV/HCV-coinfected patients (see HIV/HCV Coinfection section) and black patients (Su, 2016); (Wilder, 2016); (O’Brien, 2014); (Ioannou, 2016). For others, it should be done at the discretion of the practitioner with consideration of other potential negative prognostic factors.

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