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title = "Ledipasvir/sofosbuvir fixed-dose combination for treatment of hepatitis C virus genotype 4 infection",
This study is being done to see if two different regimens, ledipasvir with sofosbuvir and ribavirin for 12 weeks (Group A) and ledipasvir with sofosbuvir for 24 weeks (Group are well tolerated in HCV-infected persons where previous treatment with sofosbuvir failed. This study will also look at the safety of each regimen and how well the research intervention combination of ledipasvir/sofosbuvir works in people who have cirrhosis (scarring of the liver) or HIV.
In conclusion, our findings show that ledipasvir-sofosbuvir plus ribavirin for 12 weeks is an effective treatment for a group of patients currently without effective treatment options—patients with advanced liver disease, including patients with decompensated liver function before and after liver transplantation. Extending treatment to 24 weeks did not appear to be associated with improved outcomes.
Express Scripts, a pharmacy benefit manager, pushed back against the price of Sovaldi and Gilead’s follow-up drug, Harvoni, which has a list price of $93,400. It backed AbbVie’s Viekira Pak, saying it had gotten a significant discount.
Keywords: Clinical trial, combination therapy, hepatitis C virus, pegylated-interferon, polymerase inhibitors, resistance, ribavirin, sofosbuvir.
Foster, G. R. et al . Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N. Engl. J. Med. 373. 2608 – 2617 ( 2015 ).
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Until Sovaldi came to market, people with hepatitis C often faced low cure rates with treatments such as interferon and ribavirin, both of which have debilitating side effects. Many people with hepatitis C eventually need a liver transplant.
The 6,000,000 IU/mL level was selected after post hoc comparisons of virological relapse rates in the 8-week and 12-week arms of the ION-3 trial conducted during the prelicensure statistical review for ledipasvir/sofosbuvir.[4 ] Statistical interaction between the two 8-week arms combined (with or without ribavirin, n = 429) and the 12-week arm (n = 216) of ION-3 was examined for 13 HCV RNA categories (Table 1 ). For subgroup analyses, an examination of relapse rates (or a “per protocol” analysis of SVR) has greater statistical power (and other advantages) compared to an intention-to-treat analysis; however, statistical power for the interaction analyses of HCV RNA remained extraordinarily low due to the small number of patients who relapsed, most importantly only three in the 12-week arm. Based on the ION-3 data, we calculate that the power was only 5% to detect a statistically significant association ( P < 0.05) for a two-fold interaction between the 8-week and 12-week arms (based on the 6,000,000 IU/mL threshold) and that >4000 subjects would have been required to provide adequate statistical power for assessing an effect of HCV RNA in that manner. Consequently, the likelihood of detecting a statistically significant association in that analysis was extremely small even without adjusting for the multiple statistical comparisons that were made. It is not surprising, therefore, that although the smallest of the 13 P values was observed for the 6,000,000 IU/mL categorization, the P value for that finding ( P = 0.20) did not approach even nominal statistical significance. Furthermore, much larger P values were seen for the next lower (5,000,000 [6.70 log 10 ] IU/mL, P = 1.0) and next higher (7,000,000 [6.85 log 10 ] IU/mL, P = 0.55) HCV RNA cutoffs (Table 1 ), providing additional evidence that the P value nadir observed for the 6,000,000 IU/mL threshold is likely a statistical artifact.
All common adverse events (more then 10 percent in any group) occurred more frequently in subjects receiving peg-IFN and RBV as compared to sofosbuvir and RBV. The most common adverse events in the sofosbuvir plus RBV arm occurring in more then 10 percent of the patients were fatigue, headache, nausea, insomnia and dizziness .
Bangalore, March 27, 2015: Strides Arcolab Limited (Strides) today announced the launch of generic drug Sofosbuvir in India under the brand name 'Virso'. In September 2014, Strides entered into a licensing agreement with Gilead Sciences, Inc to bring Hepatitis C cure to 91 developing countries. The product will be available to Indian patients shortly.