Pros and Cons: Harvoni vs. Viekira Pak

[Hep Editors]

• In Phase III clinical trials including people with genotype 1, Harvoni demonstrated cure rates of 94 to 99 percent. Viekira Pak’s cure range was essentially the same, at 95 to 100 percent.
• Harvoni is only one pill, once a day. Viekira Pak treatment involves taking two doses of one pill once a day and one dose of another pill twice a day.
• Harvoni treatment does not include ribavirin. But people with genotype 1a, as well as those with cirrhosis or who have had a liver transplant, must take ribavirin with Viekira Pak.
• Another major benefit of Harvoni over Viekira Pak: An estimated 45 percent of people with genotype 1 of hep C will only need to take Harvoni for eight weeks instead of 12.
• With Viekira Pak, a smaller selection of HIV antiretrovirals have been certified as safe to take with the hep C therapy. A more robust number can be safely combined with Harvoni.
• Viekira Pak has a list price of $83,319 for 12 weeks of treatment. Harvoni costs $63,000 for eight weeks or $94,500 for 12 weeks of treatment.

For a more in-depth comparison: http://www.hepmag.com/articles/treatment_landscape_2502_26704.shtml

[apache]

Another dimension of the comparison relates to their different side effect profiles.  There is a paper which analyzes this, available at:

Reference: http://info.adverseevents.com/safety-comparison-viekira-pak-sovaldi-harvoni-hep-c 

From that paper:

Both Viekira Pak and Harvoni drug labels indicate the following adverse reactions: fatigue, headache, nausea, diarrhea, insomnia and bilirubin elevations.

Adverse events reported for Viekira Pak that are absent from Harvoni’s drug label are listed as follows: ALT elevations, anemia, asthenia, cough, decrease in hemoglobin, dermatitis, dermatitis allergic, dermatitis contact, discolored feces, drug resistance, dyspnea, eczema, erythema, exfoliative rash, hemoglobin decreased, hyperbilirubinemia, increased INR, increasing alkaline phosphatase, irritability, jaundice, lack of appetite, liver inflammation, loss of therapeutic effect, muscle spasms, ocular icterus, other skin reactions, photosensitivity reaction, pruritus, pruritus generalized, psoriasis, rash, rash erythematous, rash generalized, rash macular, rash maculo-

And from a footnote on that paper, they explain their input data source as:

1RxFilter makes post-marketing adverse event (AE) case reports contained in the FDAs Adverse Event Reporting System (FAERS) accessible by using a combination of computer algorithms and in-house data analysis. The system accurately standardizes and normalizes ~5 million AE case reports, from 1997 on, linked to over ~2,000 FDA approved drugs and feeds those clean data into our other analytics.