This CE activity is jointly provided by ProCE, Inc. and Hospital Pharmacy. ProCE, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number 0221-9999-15-074-H01-P has been assigned to this knowledge-based home-study CE activity (initial release date 05-01-2015). This CE activity is approved for 1.5 contact hours (0.15 CEUs) in states that recognize ACPE providers. This CE activity is provided at no cost to participants. Completion of the evaluation and the post-test with a score of 70% or higher are required to receive CE credit. No partial credit will be given.

Faculty: Dennis J. Cada, PharmD, FASHP, FASCP (Editor), Founder and Contributing Editor, The Formulary; James Leonard, Drug Information Intern, College of Pharmacy, Washington State University; Terri L. Levien, PharmD, Clinical Professor, College of Pharmacy, Washington State University; and Danial E. Baker, PharmD, FASHP, FASCP, Director, Drug Information Center, and Professor of Pharmacy Practice, College of Pharmacy, Washington State University. The authors indicate no relationships that could be perceived as a conflict of interest. This activity is self-funded by Hospital Pharmacy.

Release Date: May 1, 2015

Expiration Date: May 1, 2017

Continuing Education for this activity is processed through the ProCE online CE Center. To receive CE credit, please go to:

www.ProCE.com/HPJFDR

Click to access the activity page to enroll and complete the Post-Test and Evaluation

For questions related to registering for and obtaining CE credit, contact ProCE at 630-540-2848 or Info@ProCE.com.

1. The US Food and Drug Administration (FDA)–approved indication for ombitasvir, paritaprevir, ritonavir, and dasabuvir is for the treatment of:
   1. Chronic hepatitis A infection.
   2. Chronic hepatitis B infection.
   3. Chronic hepatitis C genotype 1 infection.
   4. Chronic hepatitis C genotype 2 infection.
      
      
2. The mechanism of action of paritaprevir is best described as:
   1. Inhibition of NS3/4A protease.
   2. Inhibition of NS5A.
   3. Inhibition of HCV polymerase.
   4. Inhibition of CYP3A4 to increase concentrations of the other active ingredients. 
      
      
3. Ritonavir is included in the regimen primarily to increase the serum concentrations of which other ingredient?
   1. Dasabuvir
   2. Ombitasvir
   3. Paritaprevir
   4. Ribavirin
      
      
4. Which of the following is a contraindication to use of the ombitasvir, paritaprevir, ritonavir, and dasabuvir regimen?
   1. Cirrhosis
   2. Concomitant administration of strong inducers of CYP3A and CYP2C8
   3. Concomitant administration of strong inhibitors of CYP2D6
   4. Moderate hepatic impairment
      
      
5. The ombitasvir, paritaprevir, ritonavir, and dasabuvir regimen, without concomitant ribavirin, is in Pregnancy Category:
   1. A.
   2. B.
   3. C.
   4. X.
      
      
6. In patients with coinfection of hepatitis C virus and HIV-1 virus, which of the following is recommended?
   1. Discontinuation of antiretroviral therapy (ART) for the duration of treatment with ombitasvir, paritaprevir, ritonavir, and dasabuvir
   2. Discontinuation of all ART medications metabolized by CYP3A4
   3. Modification of doses for ART medications metabolized by CYP3A4
   4. Not treating hepatitis C virus with the ombitasvir, paritaprevir, ritonavir, and dasabuvir regimen
      
      
7. Current Infectious Disease Society of America (IDSA) and American Association for the Study of Liver Diseases (AASLD) guidelines recommend all of the following as therapeutic options for treatment-naive patients with chronic HCV genotype 1 infection, except:
   1. Ombitasvir, paritaprevir, ritonavir, and dasabuvir.
   2. Ledipasvir plus sofosbuvir.
   3. Sofosbuvir plus simeprevir.
   4. Sofosbuvir plus ribavirin.
      
      

Case History

M.D. is a 65-year old male with controlled hypertension, hyperlipidemia, major depressive disorder, and recently diagnosed chronic hepatitis C infection genotype 1b. He has no known drug allergies. His current medications include lisinopril, hydrochlorothiazide, simvastatin, and paroxetine. He is negative for both cirrhosis and fibrosis and is asymptomatic. Baseline HCV RNA titer was 6.50 log₁₀ IU/mL. He is newly diagnosed and has not previously been treated for hepatitis C. His physician had requested information regarding the use of ombitasvir, paritaprevir, ritonavir, and dasabuvir.

8. What is the recommended treatment duration with the ombitasvir, paritaprevir, ritonavir, and dasabuvir regimen for M.D.?
   1. 12 weeks
   2. 12 weeks with ribavirin
   3. 24 weeks
   4. 24 weeks with ribavirin
      
      
9. How frequently should liver enzymes be monitored in M.D., if therapy with ombitasvir, paritaprevir, ritonavir, and dasabuvir is initiated?
   1. Prior to treatment and when clinically indicated
   2. Six weeks after initiation of therapy
   3. Only if symptoms suggestive of hepatic impairment are observed
   4. Liver enzyme monitoring is not recommended
      
      
10. What is the recommended dose of ombitasvir, paritaprevir, ritonavir, and dasabuvir for M.D.?
    1. One tablet containing ombitasvir (12.5 mg), paritaprevir (75 mg), and ritonavir (50 mg) once daily, and one tablet of dasabuvir (250 mg) twice daily
    2. Two tablets containing ombitasvir (12.5 mg), paritaprevir (75 mg), and ritonavir (50 mg) twice daily, one tablet of dasabuvir (250 mg) twice daily; and ribavirin, dosed by weight, twice daily
    3. One tablet containing ombitasvir (12.5 mg), paritaprevir (75 mg), and ritonavir (50 mg) twice daily, and one tablet of dasabuvir (250 mg) twice daily
    4. Two tablets containing ombitasvir (12.5 mg), paritaprevir (75 mg), and ritonavir (50 mg) once daily, and one tablet of dasabuvir (250 mg) twice daily
       
       
11. Which of M.D.’s medications should be changed prior to treatment with ombitasvir, paritaprevir, ritonavir, and dasabuvir?
    1. Hydrochlorothiazide
    2. Paroxetine
    3. Simvastatin
    4. No changes are necessary.
       
       
12. The most common side effects associated with ombitasvir, paritaprevir, ritonavir, and dasabuvir without ribavirin include: 
    1. Nausea, headache, and insomnia.
    2. Nausea, pruritus, and insomnia.
    3. Fatigue, nausea, and pruritus.
    4. Fatigue, abnormal liver function tests, and asthenia.
       
       
13. Which of the following points should be emphasized when counseling M.D.?
    1. Avoid sun exposure.
    2. Avoid grapefruit.
    3. Do not discontinue therapy without guidance from your provider.
    4. Doses must be taken with a high-fat meal.
       
       
14. M.D. has been taking ombitasvir, paritaprevir, ritonavir, and dasabuvir for 1 month. He has a dental appointment in the next week and he is very nervous about the procedure. Which of the following medications can be used with caution in M.D. prior to his dental appointment?
    1. Alprazolam
    2. Midazolam
    3. Phenobarbital
    4. Triazolam
       
       
15. How should M.D. be instructed to store his ombitasvir, paritaprevir, ritonavir, and dasabuvir?
    1. At or below 86°F (30°C), away from children
    2. In the refrigerator at all times
    3. In the freezer
    4. Between 68°F and 77°F (20°C and 25°C), with no exceptions