2015年11月22日星期日

Abbvie HCV DRUG Viekira Pak clinical results comparable to Gilead

In the 2015 annual meeting of the American Association for Study of Liver Diseases (AASLD), the Abbvie announced the latest clinical data hepatitis C VIEKIRA PAK of new drugs, drug treatment with or without cirrhosis in chronic hepatitis C virus gene type 1 infected patients 12 weeks cure rate of 95%! This further strengthened confirmed previous clinical data. It expects peak annual sales will reach $ 3 billion, will become a star Gilead hepatitis C drug Harvoni powerful competitors.
Viekira Pak has received FDA approval to market in December 2014, is the first to qualify for breakthrough drugs FDA accelerated approval of new drugs. Viekira Pak contains three new drugs - Ombitasvir, Paritaprevir and Dasabuvir, which together inhibit the growth of HCV. The drugs also contain ritonavir, which is a previously approved drug, which is used to increase blood levels of Paritaprevir. Viekira Pak may or may not be used with ribavirin, but this medication is not recommended for patients with liver does not work properly (decompensated cirrhosis) is used.
3b TOPAZ-II clinical study of cure data from ongoing research aimed at long-term therapeutic gene 1a and 1b adult chronic hepatitis C virus infection. 95% (n = 586/615) of patients in the 12 to 24 weeks after treatment had a sustained viral response, reaching the key secondary clinical endpoints.
TOPAZ-II is a single-group, open-label, 3b multi-center clinical study for the evaluation of treatment with ribavirin (+/-), cirrhosis (+/-), initial treatment or interferon (pegIFN / RBV) therapy Chronic hepatitis C genotype 1 infection who had 12 or 24 weeks of treatment. The clinical study is accompanied by up to 5 years of follow-up survey after treatment negative rate.
Trial included 615 cases of patients, 115 cases (19%) patients with cirrhosis and 500 cases (81%) patients without cirrhosis. 1, clinical treatment, the patient virus corresponding failure accounted for 0.8% (5/615), 1.9% (n = 11/590) of patients relapse. 1% (n = 6/615) of patients discontinued treatment because of side effects. 4% (n = 25/615) experienced a serious adverse event. Because 20/474 (4.2%) of the patients after injection of ribavirin emergence of hemoglobin decrease, so in 30/474 (6.3%) patients because of anemia and reduction of ribavirin dosage. The most commonly reported adverse events were fatigue, nausea, headache, itching and insomnia, accounting for 10% of patients.
This year's annual meeting of the American Association for Study of Liver Diseases described as fruitful, including Gilead (Gilead), Merck (Merck & Co), Bristol-Myers Squibb (BMS), including pharmaceutical giants have announced the latest development in meeting their hepatitis C drugs Advances in clinical results are excellent (Related reading: Bristol DRUG Daklinza 12 weeks of treatment of hepatitis C with advanced fibrosis 3 hepatitis C cure rate of 100). With the entry of other pharmaceutical companies, the competition in the field of HCV treatment will become more intense, I believe the price will gradually decline hepatitis C drugs, which the majority of patients with hepatitis C is a very good thing.

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