Breaking News: Viekira Pak Approved for Hep C
The race for better Hepatitis C treatments just got closer with the approval of another all-oral drug regimen. The U.S. Food and Drug Administration (FDA) approved AbbVie Inc’s new multi-drug combination on December 19, heightening the competition for Hepatitis C treatment before the end of 2014.
As more medications demonstrate a supreme ability to battle Hepatitis C, the standard of care continually improves. On December 19, 2014, Viekira Pak became the fourth drug treatment approved since November 2013 to treat chronic Hepatitis C. The previous three are:
- Olysio (simeprevir) was FDA approved November 2013.
- Sovaldi (sofosbuvir) was FDA approved December 2013.
- Harvoni (ledipasvir and sofosbuvir) was FDA approved October 2014.
Working together to inhibit the growth of Hepatitis C, AbbVie’s Viekira Pak contains three oral medications in one package. The Pak consists of ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets. It can be taken with or without ribavirin. Most people will take the Viekira Pak for 12 weeks, but some need twice as long.
There are four basic conditions that must be met for a course of therapy to be the treatment of choice for Hepatitis C:
- The medications must be FDA approved.
- The cure rate must be very high.
- The side effects must be minimal.
- The price should be as reasonable as possible.
With the FDA approval of the Viekira Pak for treating patients with chronic Hepatitis C genotype 1 infection (the most common variety in the U.S.) being official, it is now a top Hepatitis C therapy contender.
There is much debate on whether or not successful Hepatitis C treatment is equivalent to a cure; however, attaining sustained virologic response (SVR) is considered to be the closest you can get to being cured of this virus. SVR is defined as having no detectable Hepatitis C in the blood six months following the end of therapy. In trials, the Viekira Pak has demonstrated a high cure rate.
The Viekira Pak was studied in six clinical trials enrolling over 2,300 participants with chronic Hepatitis C infection with and without cirrhosis. Participants were randomly assigned to receive:
- Viekira Pak or a sugar pill (placebo)
- Viekira Pak with or without ribavirin
- Viekira Pak with ribavirin for 12 or 24 weeks
Accounting for multiple populations and all variations occurring in the six clinical trials, the Viekira Pak demonstrated a cure rate between 91 and 100 percent.
Severe side effects have been one of the primary weaknesses of previous Hepatitis C treatment regimens. Up until 2012, the gold standard of Hepatitis C treatment was pegylated interferon and ribavirin, which were associated with extremely severe side effects. The health consequences of interferon prevented nearly half of those who began therapy to complete it. Thankfully, the newer medications seem to have less severe consequences.
The most commonly reported side effects during the Viekira Pak’s trials included:
Compared to interferon’s adverse effects, Viekira Pak’s appear to be relatively mild.
Boasting price tags far beyond the average American’s annual salary, the price of the new Hepatitis C antiviral medications have been a source of great frustration. Some health insurers are denying access to these greatly improved medications because continually financing top-of-the-line Hepatitis C treatment can quickly lead to their bankruptcy:
- A 12-week course of Sovaldi costs approximately $84,000.
- A 12-week course of Harvoni costs approximately $94,500.
According to a company spokesman on December 19, AbbVie plans to charge $83,319 for a standard 12-week treatment with the Viekira Pak. Although this price could change, this is just below Sovaldi’s $84,000 price tag and about 12 percent less than Harvoni.
Based on the Viekira Pak’s effectiveness, safety and competitively pricing, it could edge out the other top Hepatitis C treatment medications. As more pharmaceutical companies get their drugs FDA approved, the cure rate is expected to rise while the side effects and cost go down. The cost of all the new Hepatitis C treatments is still outrageously steep. Nonetheless, every new entry into the market will end up improving patient access to treatment while offering a greater chance of defeating the Hepatitis C virus.
http://hcvadvocate.org/hepatitis/easyfacts/Viekira_e.pdf, Genotype 1 Treatment: Viekira Pak, Retrieved December 21, 2014, Hepatitis C Support Project, 2014.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427530.htm, FDA approves Viekira Pak to treat hepatitis C, Retrieved December 21, 2014, US Food and Drug Administration, 2014.
http://www.fool.com/investing/general/2014/12/06/3-reasons-gilead-sciences-could-soar-in-2015.aspx, 3 Reasons Gilead Sciences Could Soar in 2015, Todd Campbell, Retrieved December 21, 2014, The Motley Fool, 2014.
http://www.medscape.com/viewarticle/836981, FDA Approves Viekira Pak for Hepatitis C, Robert Lowes, Retrieved December 21, 2014, WebMD, LLC, 2014.
http://www.wsj.com/articles/fda-approves-abbvies-hepatitis-treatment-1419019392, FDA Approves AbbVie’s Hepatitis Treatment, Peter Loftus, Retrieved December 21, 2014, Dow Jones & Company, 2014.
Daclatasvir Gets Denied
Gilead's Price Battle with Express Scripts