Viekira Pak

Ombitasvir/paritaprevir/ritonavir, sold under the brand names Technivie and Viekira Pak among others, is a medication used to treat hepatitis C. It is a fixed dose combination of ombitasvir, paritaprevir, and ritonavir. Specifically it is used together with dasabuvir or ribavirin for cases caused by hepatitis C virus genotype 1 or 4. Cure rates are around 95%. It is taken by mouth. Ombitasvir/paritaprevir/ritonavir, sold under the brand names Technivie and Viekira Pak among others, is a medication used to treat hepatitis C. It is a fixed dose combination of ombitasvir, paritaprevir, and ritonavir. Specifically it is used together with dasabuvir or ribavirin for cases caused by hepatitis C virus genotype 1 or 4. Cure rates are around 95%. It is taken by mouth. It is generally well tolerated. Common side effects include nausea, itchiness, rash, and trouble sleeping. Other side effects include allergic reactions and reactivation of hepatitis B among those previously infected. Use is not recommended in those with significant liver problems. While there is no evidence of harm with use during pregnancy, this use has not been well studied. Each of the medications works by a different mechanism. The ritonavir is present to decrease the breakdown of paritaprevir. Ombitasvir/paritaprevir/ritonavir with dasabuvir was approved for medical use in the United States in 2014 and without dasabuvir in 2015. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. The cost in the United Kingdom is 32,199.99 pounds for 12 weeks of treatment. The wholesale cost for 12 weeks in the United States is 76,653.00 USD while the combination with dasabuvir cost 83,319.00. Ombitasvir/paritaprevir/ritonavir is used together with dasabuvir or ribavirin for cases caused by hepatitis C virus genotype 1 or 4. Cure rates are around 95%. Post-market surveillance reports show hepatic decompensation and hepatic failure associated with Viekira Pak use. It is likely that most patients who experienced this had advanced cirrhosis prior to treatment initiation. Hepatic decompensation is described by rising bilirubin without ALT elevations alongside clinical symptoms such as ascites and hepatic encephalopathy. Patients should be monitored for signs of hepatic decompensation and bilirubin levels should be tested in the first four weeks of treatment and compared to baseline. It is manufactured by Abbvie. In the United States ombitasvir/paritaprevir/ritonavir together with dasabuvir is sold as Viekira Pak. Technivie consists of only ombitasvir/paritaprevir/ritonavir tablets. Ombitasvir/paritaprevir/ritonavir together with dasabuvir was approved in its first review cycle by the FDA in December 2014. The Center for Drug Evaluation and Research (CDER) designated the product for Fast Track because it had potential to treat unmet medical need. This track allows the CDER to view certain information ahead of a completed NDA to cut down the time to approval. Additionally, it was designated Breakthrough Therapy for its substantial improvement in the primary endpoint SVR12 and given Priority Review under the Prescription Drug User Fee Act allowing the review to be completed in six months rather than the standard ten months. In Europe, ombitasvir/paritaprevir/ritonavir is approved under the trade name Viekirax for combination therapy together with dasabuvir, with or without ribavirin. Sapphire I was a 12-week placebo-controlled, randomized, double-blind trial which had a primary endpoint of cure (SVR12) rate in non-cirrhotic patients with HCV GT1a and GT1b - who were new to HCV treatment - and were given Viekira Pak and ribavirin (RBV). Sapphire I reported a 96% cure rate.