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news.Bristol-Myers Squibb has announced that its hepatitis drug Daklinza (daclatasvir), an NS5A replication complex inhibitor has been approved by the US Food and Drug Administration for expanded use.
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The drug can be taken in combination of sofosbuvir with or without ribavirin in genotypes 1 and 3.
With this combination, three difficult to treat patient populations can be treated, which include chronic hepatitis C virus, patients with HIV-1 coinfection, advanced cirrhosis or post-liver transplant recurrence of HCV.
According to the company, Daklinza plus sofosbuvir combination is helpful in controlling patients suffering from chronic HCV genotype 3.
Apart from this, the company also claims that sustained virologic responses (SVR) in genotype 3 are reduced significantly in genotype 3 patients with cirrhosis with the combination of Daklinza plus sofosbuvir.
Bristol-Myers Squibb, head of U.S. commercial, Chris Boerner said: "The expanded indication for Daklinza offers an additional treatment option for multiple subsets of patients who have genotype 1 or 3 chronic HCV."
"HCV/HIV-coinfected patients and patients with advanced cirrhosis or post-transplant recurrence of HCV still pose a treatment challenge to physicians.
"As part of our commitment to the HCV community, we have sought to make new treatment options available for these and other targeted populations that have not yet been able to fully benefit from currently available next-generation medicines."
The company also mentioned about the safety and contraindications of Daklinza.
It stated that Dalkinza has contraindications with drugs that can induce CYP3A and can lower its efficacy. These include -Phenytoin, carbamazepine, rifampin, St. John’s wort (Hypericum perforatum).
Other drug interactions can include loss of therapeutic effects of the drug, possible development of resistance.
Apart from this, company also states that co-administering amiodarone with daklinza in combination with sofusbuvir is not recommended and in case of symptomatic bradycardia and where pacemakers are required, administering daklinza along with sofosbuvir and amiodarone can be fatal.