Viekira Pak: Hepatitis C Drug Side Effects & Dosage

What is Viekira Pak? What is Viekira Pak used for?

Viekira Pak is a combination of drugs used to treat
patients with hepatitis C virus (HCV) genotype 1. It contains four medicines,
dasabuvir, ombitasvir, paritaprevir, and ritonavir. Viekira Pak belongs to a
class of drugs called direct-acting antiviral agents. Similar drugs include

• boceprevir
  (Victrelis), 
• sofosbuvir
  (Sovaldi),
• simeprevir
  (Olysio),
• telaprevir
  (Incivek), and
• ombitasvir, paritaprevir, ritonavir (Technivie).

Dasabuvir, ombitasvir, and paritaprevir are antivirals that work in three
different ways to help stop HCV from multiplying. They block the effect of
proteases which are enzymes that HCV uses for making new virus, leading to
reduced numbers of HCV copies in the body. Ombitasvir blocks HCV NS5A protease
while paritaprevir blocks HCV NS3/4A protease. Dasabuvir blocks a viral
structure called NS5B palm polymerase which is also needed for replication of
HCV. Ritonavir is not active against the HCV virus. It is used to increase blood
levels of paritaprevir by inhibiting the breakdown of paritaprevir.

In clinical studies Viekira Pak, with or without ribavirin (Rebetol) HCV was
cured in 95% to 100% of patients treated. Cure was defined as undetectable
levels of HCV in the blood 3 months after treatment. The FDA approved Viekira
Pak in December 2014.

What brand names are available for Viekira Pak?

Viekira Pak

Is Viekira Pak available as a generic drug?

No

Do I need a prescription for Viekira Pak?

Yes

What are the side effects of Viekira Pak?

The most common side effects of Viekira Pak when used with
ribavirin include

• tiredness,
• nausea,
• itching,
• skin reactions such as redness or
  rash,
• sleep problems
  (insomnia), and
• feeling weak.

The most common side effects of Viekira Pak when used without ribavirin
include

• nausea,
• itching, and
• problems sleeping.

Other side effects include

• allergic reactions,
• anemia, and
• increases in
  liver
  enzymes and bilirubin.

What is the dosage for Viekira Pak?

• Viekira Pak is supplied in monthly cartons that contain enough
  medicine for 28 days. Each daily dose pack contains four tablets: two 12.5/75/50
  mg ombitasvir, paritaprevir, ritonavir tablets and two 250 mg dasabuvir tablets.
• The recommended dose of Viekira Pak is two tablets containing ombitasvir,
  paritaprevir, ritonavir in the morning and one dasabuvir tablet in the morning
  and evening. Viekira Pak should be taken with meals.
• Certain patients may also be treated with ribavirin. The dosage of ribavirin
  is based on weight and is usually administered twice daily with food.
• The recommended treatment regimen and duration of treatment for each type of
  HCV infection is as follows:
  • Patients with HCV genotype 1a without
    cirrhosis may be treated with Viekira Pak plus ribavirin for 12 weeks.
  • Patients with HCV genotype 1a with cirrhosis
    may be treated with Viekira Pak plus ribavirin for 24 weeks. (Some patients who
    have had prior treatment with other drugs may be considered for a shorter
    treatment duration of 12 weeks.)
  • Patients with HCV genotype 1b without
    cirrhosis may be treated with Viekira Pak for 12 weeks.
  • Patients with HCV genotype 1b with cirrhosis
    may be treated with Viekira Pak plus ribavirin for 12 weeks.
• No dosage adjustment is required in patients with mild liver impairment.
  Viekira Pak is not recommended for patients with moderate liver impairment and
  is contraindicated in patients with severe liver impairment.

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Which drugs or supplements interact with Viekira Pak?

• Viekira Pak interacts with many drugs. The prescribing information should be
  consulted for a complete list of drugs that interact with Viekira Pak. Viekira
  Pak should not be used with the following medications:
• Afluzosin hydrochloride (Uroxatral), a
  medicine used to treat
  benign prostate hyperplasia (BPH), due to the risk of
  hypotension (low blood pressure).
• Certain anti-seizure medications, including
  carbamazepine (Tegretol),
  phenytoin (Dilantin), and phenobarbital (Luminal), may
  decrease the blood concentrations of Viekira Pak and reduce the effectiveness of
  treatment.
• Rifampin (Rifadin, Rimactane), a component of
  many tuberculosis treatment regimens, may decrease the blood concentrations of
  Viekira Pak, reducing the effectiveness of treatment.
• Ergot derivatives which are used to treat
  migraine headaches should not be used with Viekira Pak due to the risk of ergot
  toxicity.
• Combination birth control pills that contain
  ethinyl
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