Hepatitis Treatment

PL Detail-Document #320105
This PL Detail-Document gives subscribers

additional insight related to the Recommendations published in
PHARMACISTS LETTER / PRESCRIBERS LETTER
January 2016
Hepatitis C Treatment Overview

The charts below provide hepatitis C treatment regimen options for adults based on genotype, presence of cirrhosis, and treatment history. Consider
patient-specific factors (e.g., drug interactions, adverse effects, adherence) when choosing a regimen. Information in the following charts is from the
guideline from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (AASLD/IDSA; reference
1) unless otherwise noted. Note that the AASLD/IDSA guideline is a living document, and may have been updated since publication of this
chart. Treatment options from the Canadian Association for the Study of the Liver are included separately. These guidelines are available at
http://www.liver.ca/files/Professional_Education___Partnerships/Information___Resources_for_HCP/CASL_Hep_C_Consensus_Guidelines_Update
_-_Jan_2015.pdf. Consult guidelines for information on treatment of patients with CrCl <30 mL/min, decompensated cirrhosis, HIV co-infection,
acute hepatitis C infections, treatment in children, and disease monitoring. See http://www.hep-druginteractions.org/ or product labeling for
detailed drug interaction information. Information in chart may differ from product labeling. Information from Canadian labeling is included when it
differs significantly (e.g., more conservative) from referenced U.S. labeling.
Abbreviations: ALT = alanine aminotransferase; BCRP = breast cancer resistance protein; CBC = complete blood count; GFR = glomerular filtration rate;
INR = International Normalized Ratio; NS3 protease inhibitors = telaprevir, boceprevir, simeprevir; NS5A inhibitor = nonstructural protein 5A inhibitor (i.e.,
daclatasvir, ledipasvir, ombitasvir); PEG-INF = pegylated interferon alpha; P-gp = p-glycoprotein; TSH = thyroid stimulating hormone
REGIMEN OPTIONS based on genotype, presence of cirrhosis, and treatment history.

TREATMENT NAIVE
Options from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America guidelines. For patients
with CrCl >30 mL/min.
Genotype Regimen Options (see below for regimen descriptions)
Genotype 1a (or genotype 1, Regimen A (noncirrhotic), Regimen B (cirrhosis), Regimen C, Regimen D (noncirrhotic), Regimen E (cirrhosis),
subtype unknown) Regimen F (noncirrhotic), Regimen G (cirrhosis without the Q80K polymorphism)
Genotype 1b Regimen A (noncirrhotic), Regimen B (cirrhosis), Regimen C, Regimen F (noncirrhotic), Regimen G (cirrhosis),
Regimen H
Genotype 2 Regimen A (if ribavirin cannot be used [consider 24 weeks for patients with poor baseline characteristic such as
cirrhosis]), Regimen I (12 weeks [16 weeks for cirrhosis])
More. . .
Copyright 2016 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #320105: Page 2 of 11)
TREATMENT NAIVE, continued

Options from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America guidelines. For patients
with CrCl >30 mL/min.
Genotype 3 Regimen A (noncirrhotic), Regimen B (cirrhosis), Regimen J; Regimen I (24 weeks; alternate, if interferon-ineligible)
Genotype 4 Regimen C, Regimen I (24 weeks), Regimen K; Regimen J (alternate)
Genotype 5 or 6 Regimen C; Regimen J (alternate)
REGIMEN OPTIONS based on genotype, presence of cirrhosis, and treatment history.

TREATMENT NAIVE
Options from the Canadian Association for the Study of the Liver17
Genotype Regimen Options (see below for regimen descriptions)17
Genotype 1a Regimen C (cirrhotic; consider if noncirrhotic but baseline HCV RNA >6 million IU/L), Regimen D, Regimen P
(noncirrhotic), Regimen F (alternate), Regimen J (alternate), Regimen Q (noncirrhotic [alternate only for patients
without the Q80K polymorphism; see footnote g]), Regimen R (cirrhotic [alternate only for patients without the Q80K
polymorphism; see footnote g])
Genotype 1b Regimen C (cirrhotic; consider if noncirrhotic but baseline HCV RNA >6 million IU/L), Regimen D (cirrhotic),
Regimen H (noncirrhotic), Regimen P (noncirrhotic), Regimen F (alternate), Regimen J (alternate), Regimen Q
(alternate; see footnote g)
Genotype 2 Regimen I (12 weeks), Regimen J (alternate), PEG-INF/ribavirin x 24 weeks (inferior regimen)
Genotype 3 Regimen I (24 weeks), Regimen J (alternate), Regimen N (alternate), PEG-INF/ribavirin x 24 weeks (inferior
regimen; noncirrhotic only)
Genotype 4 Regimen K, Regimen C, Regimen I (24 weeks; alternate), Regimen J (alternate), Regimen R (alternate; see footnote
d)
Genotype 5 Regimen J
Genotype 6 Regimen C, Regimen J (alternate)
More. . .
TREATMENT-EXPERIENCED
Options from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America guidelines. Options are
for patients with CrCl >30 mL/min.
Genotype Regimen Options (see below for regimen descriptions)
Genotype 1a, Regimen A (noncirrhotic), Regimen B (compensated cirrhosis), Regimen C (noncirrhotic), Regimen D (noncirrhotic),
failure of Regimen E (compensated cirrhosis), Regimen F (noncirrhotic), Regimen G (compensated cirrhosis without the Q80K
PEG-INF/ribavirin polymorphism), Regimen M (compensated cirrhosis), Regimen N (compensated cirrhosis)
Genotype 1b, Regimen A (noncirrhotic), Regimen B (compensated cirrhosis), Regimen C (noncirrhotic), Regimen F (noncirrhotic),
failure of Regimen G (compensated cirrhosis), Regimen H (noncirrhotic or compensated cirrhosis), Regimen M (compensated
PEG-INF/ribavirin cirrhosis), Regimen N (compensated cirrhosis)
Genotype 1, failure of Regimen N (noncirrhotic), Regimen O (cirrhosis)

sofosbuvir plus ribavirin,
with or without PEG-INF
(no prior NS5A inhibitor
use)
Genotype 1, failure of Regimen A (noncirrhotic), Regimen B (compensated cirrhosis), Regimen C (noncirrhotic), Regimen M (cirrhosis),
telaprevir, boceprevir, or Regimen N (cirrhosis)
simeprevir plus PEG-
INF/ribavirin (no prior
NS5A inhibitor use)
Genotype 1, failure of Regimen N (noncirrhotic), Regimen O (cirrhosis)
simeprevir plus sofosbuvir
(no prior NS5A inhibitor
use)
Genotype 1, failure of Postpone treatment if liver disease is minimal, until additional data are available. For patients who need urgent
treatment with any NS5A treatment (e.g., cirrhosis), treat for 24 weeks with a regimen based on NS5A inhibitor and NS3 protease inhibitor
inhibitor-containing regimen susceptibility data, plus with weight-based ribavirin, unless contraindicated).
Genotype 2, failure of PEG- Regimen I (16 or 24 weeks); alternate: Regimen J

INF/ribavirin
Genotype 2, failure of Regimen J, Regimen B (for patients not eligible to receive PEG-INF)
sofosbuvir/ribavirin
Genotype 3, failure of PEG- Regimen A (noncirrhotic), Regimen J, Regimen L (cirrhosis, PEG-INF ineligible)
INF/ribavirin
More. . .
TREATMENT-EXPERIENCED, continued
Options from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America guidelines. Options are
for patients with CrCl >30 mL/min.
Genotype 3, failure of Regimen J, Regimen L (PEG-INF ineligible)
sofosbuvir/ribavirin
Genotype 4, failure of PEG- Regimen C, Regimen I (24 weeks), Regimen J, Regimen K
INF/ribavirin
Genotype 5 and 6 Regimen C (PEG-INF/ribavirin failure); Regimen J (alternate)
Mixed genotypes Choose drugs/duration to maximize efficacy against each genotype identified. Consult expert if unclear.
TREATMENT-EXPERIENCED
Options from the Canadian Association for the Study of the Liver17
Genotype 1a, no history of Regimen C (noncirrhotic), Regimen D (see footnote e), Regimen N (cirrhotic), Regimen F (alternate), Regimen J
protease inhibitor failure (alternate), Regimen M (alternate, cirrhotic), Regimen R (alternate only for patients without the Q80K polymorphism;
see footnote f)
Genotype 1a, history of Regimen C (noncirrhotic), Regimen N (cirrhotic), Regimen J (alternate), Regimen M (alternate, cirrhotic)
protease inhibitor failure
Genotype 1b, no history of Regimen C (noncirrhotic), Regimen D (cirrhotic), Regimen H (noncirrhotic), Regimen N (cirrhotic), Regimen F
protease inhibitor failure (alternate), Regimen J (alternate), Regimen M (alternate, cirrhotic), Regimen R (alternate; see footnote f)
Genotype 1b, history of Regimen C (noncirrhotic), Regimen N (cirrhotic), Regimen J (alternate), Regimen M (alternate, cirrhotic)
protease inhibitor failure
Genotype 2 Regimen I (12 weeks, noncirrhotic), Regimen J (cirrhotic, or alternate for noncirrhotic), Regimen I (16 weeks,
alternate for cirrhotic [inferior regimen])
Genotype 3 Regimen I (24 weeks, noncirrhotic, or alternate for cirrhotic [clinically inferior for cirrhotic]), Regimen J (cirrhotic, or
alternate, noncirrhotic), Regimen N (alternate, noncirrhotic)
Genotype 4 Regimen K (not for prior protease inhibitor failure), Regimen C, Regimen I (24 weeks, alternate), Regimen J
(alternate), Regimen R (alternate; not for prior protease inhibitor failure; see footnote d)
Genotype 5 Regimen J
Genotype 6 Regimen C, Regimen J (alternate)
More. . .
REGIMEN DESCRIPTIONS
Regimenc Regimen Description
A Daclatasvir (Daklinza) 60 mga + sofosbuvir (Sovaldi) 400 mg daily x 12 weeks
B Daclatasvir (Daklinza) 60 mga + sofosbuvir (Sovaldi) 400 mg daily x 24 weeks with/without weight-based ribavirin
C Ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) daily x 12 weeks
D Paritaprevir 150 mg/ritonavir 100 mg/ombitasvir 25 mg daily, plus twice-daily dasabuvir 250 mg (Viekira Pak [U.S.], Holkira Pak
[Canada]) plus weight-based ribavirinb x 12 weeks
E Paritaprevir 150 mg/ritonavir 100 mg/ombitasvir 25 mg daily, plus twice-daily dasabuvir 250 mg (Viekira Pak [U.S.], Holkira Pak
[Canada]) plus weight-based ribavirinb x 24 weeks
F Simeprevir (Olysio [U.S.], Galexos [Canada]) 150 mg plus sofosbuvir (Sovaldi) 400 mg daily x 12 weeks
G Simeprevir (Olysio [U.S.], Galexos [Canada]) 150 mg plus sofosbuvir (Sovaldi) 400 mg daily with or without weight-based ribavirinb x
24 weeks
H Paritaprevir 150 mg/ritonavir 100 mg/ombitasvir 25 mg daily, plus twice-daily dasabuvir 250 mg (Viekira Pak [U.S.], Holkira Pak
[Canada]) x 12 weeks
I Sofosbuvir (Sovaldi) 400 mg daily plus weight-based ribavirinb
J Sofosbuvir (Sovaldi) 400 mg daily plus weight-based ribavirin plus weekly PEG-INF x 12 weeks
K Paritaprevir 150 mg/ritonavir 100 mg/ombitasvir 25 mg daily (Technivie), plus weight-based ribavirinb x 12 weeks
L Daclatasvir (Daklinza) 60 mga + sofosbuvir (Sovaldi) 400 mg daily x 24 weeks with weight-based ribavirin
M Ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) daily x 24 weeks
N Ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) daily plus weight-based ribavirinb x 12 weeks
O Ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) daily plus weight-based ribavirinb x 24 weeks
More. . .
Regimenc Regimen Description

P Ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) daily x 8 weeks
Q Simeprevir 150 mg once daily x 12 weeks plus PEG-INF plus weight-based ribavirinb x 24 weeks
R Simeprevir 150 mg once daily x 12 weeks plus PEG-INF plus weight-based ribavirinb x 24 to 48 weeks
a. Dose adjustment needed based on concomitant use of CYP3A4 inhibitors/inducers.

b. Weight-based ribavirin dosing: 1000 mg (<75 kg) or 1200 mg (>75 kg), divided. Requires dose adjustment if CrCl <50 mL/min.
c. Regimen designations as A, B, C, etc are for purposes of this PL Chart only, and are not designations used outside of this chart.
d. Treatment-naive and previous relapsers should be treated for 24 weeks total (12 weeks simeprevir/PEG-INF/ribavirin, then 12 weeks of PEG-
INF/ribavirin) if HCV RNA <25 IU/mL at week four and undetectable at week 12. Otherwise, discontinue treatment. Partial or null responders
should be treated for 48 weeks total (12 weeks of simeprevir/PEG-INF/ribavirin, then 36 weeks of PEG-INF/ribavirin) if HCV RNA <25 IU/mL at
week 4 and undetectable at weeks 12 and 24. Otherwise, discontinue treatment. (Note that partial or null responders will have a low probability of
sustained virological response to this regimen, so other regimens should be considered.)17
e. Those with cirrhosis plus previous null response to PEG-INF/ribavirin should get Regimen E (24 weeks) instead of Regimen D (12 weeks).
Relapsers and partial responders with cirrhosis can be treated with Regimen D (12 weeks).17
f. Previous null responders should not be treated with Regimen R. Previous relapsers should be treated for 24 weeks total if HCV RNA
<25 IU/mL at week four and undetectable at week 12. Otherwise, discontinue treatment. Partial responders should be treated for 48 weeks total if
HCV RNA <25 IU/mL at week four and undetectable at weeks 12 and 24. Otherwise, discontinue treatment.17
g. Patients who have HCV RNA >25 IU/mL at week four or detectable HCV RNA at week 12 should discontinue treatment.17
THERAPEUTIC CONSIDERATIONS
Selected Considerations Related to Common Adverse Effects Monitoring
Drug Interactions (see footnote h) See guideline for information regarding quantitative HCV
testing.
All regimens
All may interact with certain See individual agents Within 12 weeks before starting: CBC, INR, liver function,
anticonvulsants and HIV antivirals. GFR (calculated)
All but sofosbuvir can interact with After four weeks and as clinically indicated: CBC,
certain statins creatinine, GFR (calculated), liver function
Discontinue treatment if ALT at week four increases
tenfold, or increase is accompanied by symptoms, or
increased bilirubin, alkaline phosphatase, or INR
Otherwise, asymptomatic increases in ALT at week four
should prompt repeat ALT at weeks six and eight. Consider
discontinuation in the event of persistent elevation.
More. . .

testing.
Daclatasvir (Daklinza)
Use with strong CYP344 inhibitors With sofosbuvir: >10% of patients have See All regimens, above
and moderate CYP3A4 inducers headache, fatigue, or nausea.6,7
requires dose adjustment.6 See
labeling.
Contraindicated with strong CYP3A4
inducers (rifampin, St. Johns wort).6
Ledipasvir (component of Harvoni, with sofosbuvir)

Acid-suppressive medications can With sofosbuvir (in Harvoni): >10% of See All regimens, above
decrease absorption. Avoid if patients have headache, weakness, or
possible. However, if needed use the fatigue;8 >5% of patients have nausea or
following recommendations. insomnia.8
Separate from antacids by four hours.
H2-blockers can be given with or 12
hours apart from Harvoni at a dose
not greater than famotidine 40 mg
twice daily, or equivalent. Proton
pump inhibitors can be used if the
dose does not exceed omeprazole
20 mg daily or equivalent.8
Use of Harvoni with amiodarone
may result in serious bradycardia,
and is not recommended.8
Does not affect CYP450 enzymes.
Substrate and inhibitor of P-gp.
Inhibits BCRP.
Use with rosuvastatin is not
recommended.8
More. . .

testing.
Paritaprevir/ritonavir/ombitasvir/dasabuvir (Viekira Pak [U.S.], Holkira Pak [Canada], Technivie [does not contain dasabuvir])
Has the most potential drug interactions. >5% of patients (without ribavirin): See All regimens, above
nausea, itching, insomnia, skin
Ombitasvir, paritaprevir, and dasabuvir reactions10 In patients with Child-Pugh A cirrhosis, check total and
Technivie (with ribavirin): >10% of
10
are inhibitors of UGT1A1. direct bilirubin and transaminases every one to two weeks
Ritonavir is an inhibitor of CYP3A4. 10
patients: weakness, fatigue, nausea, for the first four weeks. Educate patients to report
Paritaprevir is an inhibitor of insomnia 15
symptoms of liver injury such as jaundice, weakness, or
OATP1B1 and OATP1B3.10 Contraindicated in moderate or severe fatigue. Discontinue immediately in the event of liver
Paritaprevir, ritonavir, and dasabuvir hepatic impairment (Child-Pugh B and injury.
are inhibitors of BCRP.10 C) due to risk of hepatic
Paritaprevir and ritonavir are decompensation.10,15,19
metabolized mainly by CYP3A4.10
Dasabuvir is metabolized mainly by
CYP2C8.10
Ombitasvir, paritaprevir, dasabuvir,
and ritonavir are substrates of P-
glycoprotein.10
Ombitasvir, paritaprevir, and dasabuvir
are substrates of BCRP.10
Paritaprevir is a substrate of OATP1B1
and OATP1B3.10
Contraindicated Drugs:10,11,15,18,i
alfuzosin, bosentan (Canada),
carbamazepine, cisapride (Canada),
colchicine (U.S.), ergots, efavirenz,
ethinyl estradiol, etravirine (Canada),
gemfibrozil (not Technivie), lovastatin,
midazolam (oral), modafinil (Canada),
nafcillin (Canada), nevirapine (Canada,
Technivie), phenytoin, phenobarbital,
pimozide, rifampin, salmeterol (Canada),
sildenafil (for pulmonary hypertension),
simvastatin, St. Johns wort, triazolam
More. . .

testing.
Simeprevir (Olysio [U.S.], Galexos [Canada])
CYP3A4 substrate and weak With sofosbuvir (Sovaldi): >20% of See All regimens, above
intestinal CYP3A4 inhibitor.12 patients have fatigue, headache, or
Weak CYP1A2 inhibitor.12 nausea.12
Inhibits P-gp and OATP1B1/3.12
Atorvastatin (max dose 40 mg),
rosuvastatin (max dose 10 mg)12
Use with moderate or strong
CYP3A4 inhibitors or inducers is not
recommended.12
Sofosbuvir (Sovaldi)
Generally, has fewest drug With ledipasvir (in Harvoni): >10% of See All regimens, above
interactions. patients have headache, fatigue, or
Use with amiodarone and another weakness;8 >5% of patients have nausea
direct-acting antiviral may result in or insomnia.8
serious bradycardia; avoid.2,3 With simeprevir (Olysio): >20% of
No CYP450-mediated interactions. patients have fatigue, headache, or
Substrate of P-gp and BCRP. nausea.12
Does not interact with statins.
P-gp inducers may reduce levels.4
Ribavirin (Copegus [U.S.], Rebetol capsule and solution, [U.S.]; Ibavyr [Canada], Pegetron [Canada; includes peginterferon alpha-2b], Pegasys RBV
[Canada; includes peginterferon alpha-2a])
Minimal potential for CYP450- With sofosbuvir (Sovaldi): >20% of Pregnancy test at baseline, then monthly during treatment
4
mediated interactions. 14
patients have fatigue or headache. and for six months after discontinuation.5,13
Contraindicated with didanosine With ombitasvir, paritaprevir, and ritonavir
5,13-15 (Technivie [U.S.]): >10% of patients have Patients with cardiac disease should have a baseline
(Canada, not recommended).
weakness, fatigue, nausea, or insomnia.16 electrocardiogram (due to cardiac risk conferred by
With simeprevir (Olysio) and PEG-INF: anemia).5,13
>20% of patients have
Continued rash/photosensitivity, itching, or nausea.12 CBC at baseline, weeks two and four, and periodically.5
More. . .

testing.
Ribavirin, With ledipasvir and sofosbuvir (Harvoni): Biochemical tests (e.g., liver function, uric acid) at baseline,
continued >10% of patients have weakness or week two (Pegetron), week four, and periodically.5,13,16
headache.8
With paritaprevir/ritonavir/ Dose reduction or discontinuation may be indicated in the
ombitasvir/dasabuvir (Viekira Pak, Holkira event of hemoglobin reduction.5,13
Pak): >10% of patients have fatigue,
nausea, dermatologic reactions, insomnia, Also see All regimens, above.
or weakness.10
PEG-INF (PegIntron [U.S.], Pegasys, Pegetron [Canada; includes ribavirin], Pegasys RBV [Canada; includes ribavirin])
May increase levels of drugs With ribavirin and sofosbuvir (Sovaldi): TSH within 12 weeks before starting, and every
metabolized by CYP1A2 (e.g., >20% of patients have fatigue, headache, 12 weeks.
theophylline) or methadone.14 nausea, insomnia, or anemia4 Monitor for depression/suicidal ideation.9,14
CBC at baseline, weeks two and four, and periodically.9,14
Biochemical tests (e.g., liver and renal function) at
baseline, week two (Pegetron), week four, and
periodically.9,14,16
Dose reduction or discontinuation may be indicated in the
event of depression, neutropenia, thrombocytopenia, ALT
elevation, or renal impairment.9,14
Eye exam at baseline, and periodically in patients with
pre-existing ophthalmic disorders (e.g., retinopathy) or in
those who develop vision problems.9,14
Triglycerides periodically.14
Also see All regimens, above.
h. Not a complete list of drug interactions. For additional drug interactions, see http://www.hep-druginteractions.org/, U.S. MedGuide, and
product labeling.
i. Contraindicated with drugs highly dependent on CYP3A4 for metabolism.10 Contraindicated with moderate or strong CYP3A4 inducers.10
Also contraindicated with strong CYP2C8 inhibitors or inducers due to dasabuvir component (does not apply to Technivie15).10
Users of this PL Detail-Document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making
clinical judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national
organizations. Information and internet links in this article were current as of the date of publication.
More. . .
Project Leader in preparation of this PL Detail- 9. Product information for Pegasys. Genentech, Inc.
Document: Melanie Cupp, Pharm.D., BCPS South San Francisco, CA 94080. March 2015.
10. Product information for Viekira Pak. AbbVie Inc.
North Chicago, IL 60064. October 2015.
References 11. Product monograph for Holkira Pak. AbbVie
1. American Association for the Study of Liver Diseases Corporation. Saint Laurent, QC H4S 1Z1. October
and Infectious Diseases Society of America. HCV 2015.
guidance: recommendations for testing, managing, 12. Product information for Olysio. Janssen Products
and treating hepatitis C. http://hcvguidelines.org/full- LP. Janssen Therapeutics. Titusville, NJ 08560.
report-view. (Accessed December 13, 2015). October 2015.
2. U.S. Food & Drug Administration. FDA drug safety 13. Product information for Rebetol. Merck & Co., Inc.
communication: FDA warns of serious slowing of the Whitehouse Station, NJ 08889. May 2015.
heart when antiarrhythmic drug amiodarone is used 14. Product information for PegIntron. Merck & Co., Inc.
with hepatitis C treatments containing sofosbuvir Whitehouse Station, NJ 08889. May 2015.
(Harvoni) or Sovaldi in combination with another 15. Product information for Technivie. AbbVie Inc.
direct acting antiviral drug. March 24, 2015. North Chicago, IL 60064. October 2015.
http://www.fda.gov/Drugs/DrugSafety/ucm439484.ht 16. Product monograph for Pegetron kit. Merck Canada
m. (Accessed November 24, 2015). Inc. Kirkland, QC H9H 4M7. February 2015.
3. Health Canada. Amiodarone-slow heart rate in 17. Myers RP, Shah H, Burak KW, et al. An update on
patients taking amiodarone together with Harvoni or the management of chronic hepatitis C: 2015
Sovaldi and a direct acting antiviral. April 2, 2015. consensus guidelines from the Canadian Association
http://healthycanadians.gc.ca/recall-alert-rappel- for the Study of the Liver. Can J Gastroenterol
avis/hc-sc/2015/52801a- Hepatol 2015;29:19-34.
eng.php?_ga=1.6879089.259317099.1448392445. 18. Product monograph for Technivie. AbbVie
(Accessed November 24, 2015). Corporation. Saint-Laurent, QC H4S 1Z1. October
4. Product information for Sovaldi. Gilead Sciences, 2015.
Inc. Foster City, CA 94404. August 2015. 19. Health Canada. Information update-risk of serious
5. Product information for Copegus. Genentech, Inc. liver injury associated with hepatitis C treatments:
South San Francisco, CA 94080. August 2015. Holkira Pak and Technivie. November 10, 2015.
6. Product information for Daklinza. Bristol-Myers http://healthycanadians.gc.ca/recall-alert-rappel-
Squibb Company. Princeton, NJ 08543. July 2015. avis/hc-sc/2015/55800a-eng.php. (Accessed
7. Product monograph for Daklinza. Bristol-Myers December 12, 2015).
Squibb Canada. Montreal, QC H4S 0A4. August
2015.
8. Product information for Harvoni. Gilead Sciences,
Inc. Foster City, CA 94404. November 2015.
Cite this document as follows: PL Detail-Document, Hepatitis C Treatment Overview. Pharmacists

Letter/Prescribers Letter. January 2016.
Evidence and Recommendations You Can Trust

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PL Detail-Document #320105

This PL Detail-Document gives subscribers

Hepatitis C Treatment Overview

REGIMEN OPTIONS based on genotype, presence of cirrhosis, and treatment history.

TREATMENT NAIVE, continued

Genotype 5 or 6 Regimen C; Regimen J (alternate)

REGIMEN OPTIONS based on genotype, presence of cirrhosis, and treatment history.

Genotype 6 Regimen C, Regimen J (alternate)

Genotype 1, failure of Regimen N (noncirrhotic), Regimen O (cirrhosis)

Genotype 2, failure of PEG- Regimen I (16 or 24 weeks); alternate: Regimen J

C Ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) daily x 12 weeks

I Sofosbuvir (Sovaldi) 400 mg daily plus weight-based ribavirinb

M Ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) daily x 24 weeks

N Ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) daily plus weight-based ribavirinb x 12 weeks

O Ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) daily plus weight-based ribavirinb x 24 weeks

Regimenc Regimen Description

a. Dose adjustment needed based on concomitant use of CYP3A4 inhibitors/inducers.

Selected Considerations Related to Common Adverse Effects Monitoring

Ledipasvir (component of Harvoni, with sofosbuvir)

Selected Considerations Related to Common Adverse Effects Monitoring

Selected Considerations Related to Common Adverse Effects Monitoring

Selected Considerations Related to Common Adverse Effects Monitoring

Cite this document as follows: PL Detail-Document, Hepatitis C Treatment Overview. Pharmacists

Evidence and Recommendations You Can Trust

Subscribers to the Letter can get PL Detail-Documents, like this one,

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