The US Food and Drug Administration
(FDA) has recently granted approval for interferon-free treatment for those
affected with hepatitis C genotype 1. The treatment offers a 12-week IFN-free,
The combination of 2-3
direct-acting antiviral agents (DAAs) will be able to result in 90 percent
sustained virologic response (SVR) rates mostly in patient with genotype 1
infection. The list includes patients with subtype 1a, treatment-experienced patients and patients with advanced
liver disease - cirrhosis. Some of these regimens may be ribavirin (RBV)
free. It is incredible news to most patients as their wait is almost over,
especially, for those with genotype 1 infection.
The drug Viekira Pak treats patients with chronic hepatitis C
virus (HCV) genotype 1 infection. This also includes those with cirrhosis, a
type of advanced liver disease. Viekira Pak includes - ombitasvir, paritaprevir
and dasabuvir - the three new drugs that inhibit growth of HCV. It includes a
previously approved drug - ritonavir, which helps increase the blood levels of
paritaprevir. For patients with unstable functioning of the liver, Viekira Pak
intake is recommended along with ribavirin. For others, Viekira Pak can be
consumed with or without ribavirin.
"The new generation of therapeutics
for hepatitis C virus is changing the treatment paradigm for Americans living
with the disease," said Edward Cox, M.D., M.P.H., The Director, Office of
Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "We
continue to see the development of new all-oral treatments with very high
virologic response rates and improved safety profiles compared to some of the
older interferon-based drug regimens."
The effectiveness of Viekira Pak
was estimated through six clinical trials with 2.308 participants. All
participants were affected by chronic HCV infection, some with cirrhosis and
some without cirrhosis. The participants were given Viekira Pak with or without
ribavirin for a 12 to 24 weeks period. Trials measured if HCV was no longer
found in blood at least 12 weeks after treatment. Multiple population results
revealed that 91 to 100 percent participants who were given Viekira Pak in
recommended dosages accomplished SVR.
Hepatitis C - The Viral Disease:
HCV causes inflammation of the liver and reduces liver
function. It may also lead to liver failure or liver cancer. Many of them
infected with Hepatitis C diagnose only at the condition of liver damage and
this can take decades. Apparently there are no symptoms for the infection. The
Centers for Disease Control and Prevention reveals that HCV affects about 3.2
million Americans. About 15 to 30 precent of them developed cirrhosis due to
lack of treatments.