Hepatitis C Virus Treatments

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HEPATITIS C VIRUS TREATMENTS
HEPATITIS C VIRUS TREATMENTS

Characteristics of Persons for Whom Therapy is
Widely Accepted:

• Age ≥18yrs; Hepatitis C Virus (HCV)-RNA serum
positive

• Compensated liver disease (total serum bilirubin
<1.5g/dL; INR 1.5; serum albumin >3.4; platelet
count 75,000mm; and no evidence of hepatic de-
compensation (hepatic encephalopathy or ascites)

• Acceptable hematological and biochemical indices:
Hemoglobin 13g/dL for men and 12g/dL for
women; neutrophil count 1500/mm³ and serum
creatinine <1.5mg/dL

Generic Brand Usual Initial Dosage
DUAL THERAPY
daclatasvir + sofosbuvir Daklinza1 + Sovaldi Adults: ≥18yrs: 60mg once daily + Sovaldi 400mg once daily for 12wks. Concomitant CYP3A substrates: Adjust Daklinza dose to 30mg once daily (strong inhibitors) or 90mg once daily (moderate inducers).
Children: <18yrs: Not established
interferon alfa‑2b + ribavirin Intron A + Rebetol3 Adults: ≥18yrs: 3million IU SC three times weekly + Rebetol 1000mg (≤75kg) or 1200mg (>75kg) in 2 divided doses for 48wks (genotype 1) or 24wks (genotype 2,3); Retreatment: 24wks.
Children: ≥3yrs: 25−61kg: 3million IU/m² SC three times weekly + Rebetol 15mg/kg/day in 2 divided doses for 48wks (genotype 1) or 24wks (genotype 2,3).
peginterferon alfa‑2a + ribavirin Pegasys2 + Copegus3 Adults: ≥18yrs: Genotype 1,4: 180mcg SC once weekly + Copegus 1000mg (<75kg) or 1200mg (≥75kg) in 2 divided doses for 48wks.
Genotype 2,3: 180mcg SC once weekly + Copegus 800mg in 2 divided doses for 24wks.
Children: ≥5yrs: 180mcg/1.73m² × BSA SC once weekly + Copegus 400mg (23−33kg) or 600mg (34−46kg) or 800mg (47−59kg) or 1000mg (60−74kg) or 1200mg (≥75kg) divided in AM & PM for 48wks (genotype 1,4) or 24wks (genotype 2,3); see full labeling.
peginterferon alfa‑2b + ribavirin PegIntron2 + Rebetol3 Adults: ≥18yrs: 1.5mcg/kg/wk SC + Rebetol 800mg (<66kg) or 1000mg (66−80kg) or 1200mg (81−105kg) or 1400mg (>105kg) in 2 divided doses for 48wks (genotype 1) or 24wks (genotype 2,3). Retreatment: 48wks. Prior treatment failure: Add HCV NS3/4A Protease Inhibitor (unless contraindicated); treat for 48wks.
Children: 3−17yrs: 60mcg/m²/wk SC + Rebetol 15mg/kg/day in 2 divided doses for 48wks (genotype 1) or 24wks (genotype 2, 3).
TRIPLE THERAPY
simeprevir Olysio4,6 + Sovaldi or peginterferon alfa & ribavirin Adults: Take with food. 150mg once daily. Genotype 1: Treatment-naïve or treatment-experienced: (without cirrhosis): treat for 12wks + Sovaldi; (with compensated cirrhosis [Child-Pugh A]): treat for 24wks + Sovaldi. Genotype 1 or 4: Treatment-naïve and prior relapsers in HCV mono-infected without cirrhosis or with compensated cirrhosis, or HCV/HIV co-infected without cirrhosis: treat for 12wks + peginterferon + ribavirin, followed by additional 12wks of peginterferon + ribavirin (total 24wks). Treatment-naïve and prior relapsers in HCV/HIV co-infected with compensated cirrhosis, prior non-responders (partial and null) in HCV/HIV co-infected or HCV mono-infected without cirrhosis or with compensated cirrhosis: treat for 12wks + peginterferon + ribavirin, followed by additional 36wks of peginterferon + ribavirin (total 48wks).
Children: <18yrs: Not established
sofosbuvir Sovaldi4 + peginterferon alfa & ribavirin Adults: 400mg once daily. Genotype 1: treat for 12wks with PegIFN alfa + RBV or 24wks with RBV if interferon-based regimen ineligible. Genotype 2: treat for 12wks with RBV. Genotype 3: treat for 24wks with RBV. Genotype 4: treat for 12wks with PegIFN alfa + RBV. HCV/HIV-1 co-infection: follow same dosage recommendations. Hepatocellular carcinoma: treat up to 48wks with RBV or until time of liver transplant, whichever occurs first.
Children: <18yrs: Not established.
boceprevir Victrelis4 + peginterferon alfa & ribavirin Adults: Initiate peginterferon alfa + ribavirin for 4wks. Then add 800mg Victrelis three times daily to therapy. Patients without cirrhosis: continue treatment as indicated by HCV‑RNA levels at Weeks 8, 12, and 24 (see full labeling). With cirrhosis: continue for 44wks.
Children: <18yrs: Not established.
FIXED-DOSE COMBINATION THERAPY
elbasvir/grazoprevir +/− ribavirin Zepatier +/− ribavirin Adults: 1 tab once daily. Genotype 1a: treatment-naive or PegIFN/RBV-experienced without baseline NS5A polymorphisms: treat for 12wks; with baseline NS5A polymorphisms: take with RBV for 16wks. Genotype 1b: treatment-naive or PegIFN/RBV-experienced: treat for 12wks. Genotype 1a or 1b: PegIFN/RBV/HCV NS3/4A protease inhibitor-experienced: take with RBV for 12wks. Genotype 4: treatment-naive: treat for 12wks; PegIFN/RBV-experienced: take with RBV for 16wks.
Children: <18yrs: Not established.
ledipasvir/sofosbuvir +/− ribavirin Harvoni +/− ribavirin Adults: 1 tab once daily. Genotype 1: Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A), or treatment-experienced without cirrhosis: treat for 12wks; treatment-naïve without cirrhosis who have pre-treatment HCV RNA <6 million IU/mL: can be considered for 8wks. Treatment-experienced with compensated cirrhosis: treat for 24wks; can be considered for 12wks + ribavirin (if eligible). Treatment-naïve and -experienced with decompensated cirrhosis (Child-Pugh B or C): treat for 12wks + ribavirin (see full labeling). Genotype 1 or 4: Treatment-naïve and -experienced liver transplant recipients without cirrhosis or with compensated cirrhosis: treat for 12wks + ribavirin. Genotype 4, 5, 6: Treatment-naïve and -experienced without cirrhosis or with compensated cirrhosis: treat for 12wks. HCV/HIV-1 co-infection: follow same dosage schedule. See full labeling.
Children: <18yrs: Not established.
ombitasvir/paritaprevir/ritonavir + ribavirin Technivie7 + ribavirin Adults: Take with food. ≥18yrs: 2 tabs once daily in the AM for 12wks with ribavirin. Treatment-naive (or ribavirin intolerant): may consider administering without ribavirin for 12wks.
Children: <18yrs: Not established
ombitasvir/paritaprevir/ritonavir + dasabuvir +/− ribavirin Viekira Pak8 +/− ribavirin Adults: Take with food. Give 2 ombitasvir/paritaprevir/ritonavir tabs once daily (in AM) and 1 dasabuvir tab twice daily (AM & PM). Genotype 1a without cirrhosis: treat for 12wks + ribavirin. Genotype 1a with compensated cirrhosis (Child-Pugh A): treat for 24wks + ribavirin (12wks may be considered for some). Genotype 1b with or without compensated cirrhosis: treat for 12wks. HCV/HIV-1 co-infection: follow recommendations above. Liver transplant recipients (with mild fibrosis): treat for 24wks + ribavirin. In combination with ribavirin: see full labeling.
Children: <18yrs: Not established.
MONOTHERAPY
interferon alfa‑2b Intron A Adults: 3million IU SC or IM three times weekly for 16wks; if tolerated with normalization of ALT: continue 18−24mos (72−96wks).
Children: Monotherapy not recommended.
peginterferon alfa‑2a Pegasys2,5 Adults: 180mcg SC once weekly for 48wks.
Children: Not recommended.
peginterferon alfa‑2b PegIntron2,5 Adults: 1mcg/kg/wk SC for 1yr administered on same day of the week.
Children: Not recommended.
NOTES

Key: SVR = sustained virologic response

 

1Indicated for the treatment of chronic hepatitis C genotype 3 infection in combination with sofosbuvir only.

 

2Patients who fail to achieve a 2 log10 drop at 12weeks or undetectable HCV‑RNA at Week 24 are highly unlikely to achieve SVR and discontinuation of therapy should be considered.

 

3Ribavirin should be taken orally with food. Do not use with creatinine clearance <50mL/min. Take in 2 divided doses (AM & PM): see literature.

 

4Indicated for the treatment of chronic hepatitis C infection for combination therapy only.

 

5Drug is not recommended as monotherapy unless patient cannot take ribavirin as combination treatment.

 

6Screen for HCV genotype 1a infection for NS3Q80K polymorphism prior to treatment initiation; consider alternative if Q80K polymorphism present.

 

7Indicated for the treatment of chronic hepatitis C genotype 4 infection without cirrhosis. Contraindicated in moderate-to-severe hepatic impairment.

 

8Indicated for the treatment of chronic HCV genotype 1a (in combination with ribavirin) or 1b infection without cirrhosis or with compensated cirrhosis. Contraindicated in moderate-to-severe hepatic impairment.

 

Dose modifications: Not an inclusive list of medications, official indications and/or dosing details. For dose adjustments or reductions, please see drug monograph at www.eMPR.com and/or contact company for full drug labeling.

REFERENCES

Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, Management, and Treatment of Hepatitis C: An Update. Hepatology. 2009; 49(4).

(Rev. 8/2016)

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