FDA has approved two supplemental indications for Harvoni: liver transplant patients and patients with decompensated cirrhosis
The FDA ( Food and Drug Administration ) has approved additional indications for Harvoni ( Ledipasvir / Sofosbuvir ) for use in chronic hepatitis C patients with advanced liver disease.
Harvoni in combination with Ribavirin ( RBV ) for 12 weeks was approved for use in chronic hepatitis C virus ( HCV ) genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis ( Child-Pugh A ), and for HCV genotype 1-infected patients with decompensated cirrhosis ( Child-Pugh B or C ), including those who have undergone liver transplantation.
Harvoni is now approved for use in a broader range of patient populations, including HCV genotypes 1, 4, 5 and 6, HCV/HIV-1 coinfection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with decompensated cirrhosis.
The supplemental new drug application ( sNDA ) approval for genotype 1 or 4 HCV liver transplant recipients without cirrhosis or with compensated cirrhosis, and for genotype 1 HCV patients with decompensated cirrhosis, was supported by data from the phase 2 SOLAR-1 and SOLAR-2 trials.
These open-label studies evaluated 12 and 24 weeks of treatment with Harvoni in combination with Ribavirin in HCV treatment-naïve and treatment-experienced patients with genotype 1 and 4 infection who had undergone liver transplantation and/or who had decompensated liver disease.
SVR12 rates among genotype 4 HCV post-transplant patients without cirrhosis or with compensated cirrhosis ( n=12 ) were similar to the reported genotype 1 SVR12 rates; no subjects relapsed.
Available data in subjects with genotype 4 HCV who had decompensated cirrhosis ( pre- and post-liver transplantation ) were insufficient for dosing recommendations.
A total of seven patients in the 12-week treatment arms of SOLAR-1 and SOLAR-2 had fibrosing cholestatic hepatitis ( FCH ), and all achieved SVR12.
Fibrosing cholestatic hepatitis is a rare and severe form of recurrent hepatitis that occurs following liver transplantation and is associated with high morbidity and mortality.
Previously, there were no approved treatment options for fibrosing cholestatic hepatitis.
Adverse events observed in the two SOLAR studies were consistent with the expected clinical sequelae of liver transplantation and/or decompensated liver disease, or the known safety profile of Harvoni and/or Ribavirin.
Among liver transplant and decompensated liver disease patients, 1% and 2% of patients discontinued Harvoni with Ribavirin due to an adverse event, respectively.
The most common adverse reactions ( greater than or equal to 10%, all grades ) observed with treatment with Harvoni in combination with Ribavirin for 12 weeks were asthenia, headache and cough. ( Xagena )
Source: Gilead, 2016
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