Daclatasvir-sofosbuvir combination highly effective and well tolerated in patients with hepatitis C
Results from ALLY-2 confirm drug was well tolerated and effective across genotypes 1-4
2015-04-23
(Press-News.org) April 23, 2015, Vienna, Austria: Phase III results revealed today at The International Liver Congress™ 2015 show that once-daily treatment with daclatasvir (DCV) plus sofosbuvir (SOF) resulted in an overall 97% sustained virologic response (SVR) at 12 weeks post-treatment in patients with hepatitis C virus (HCV) and HIV co-infection, including cirrhotic patients.
HIV co-infection more than triples the risk of hepatitis C-related liver disease, liver failure and liver-related death. Co-infection can also complicate the management of HIV infection.
In the ALLY-2 randomised, open-label study, the combination of DCV+SOF was well tolerated and effective across the four different genotypes. Importantly, due to their limited pharmacokinetic interactions with other agents, DCV+SOF was able to work effectively across a broad range of concomitant combination antiretroviral therapy (cART) regimens without compromising HIV virologic control (98% of patients were on cART).
The study included treatment-naive (n = 151) and treatment-experienced (n = 52) adults co-infected with HIV and HCV. Treatment-naive patients were randomised 2:1 to receive 12 or 8 weeks of SOF 400 mg + DCV 60 mg (dose adjusted for cART); experienced patients received DCV+SOF for 12 weeks. The primary endpoint was SVR at post-treatment week 12 in treatment-naive genotype-1 patients who received 12 weeks of DCV+SOF.
A total of 98% of patients completed the study treatment. In genotype-1 patients, SVR was achieved by 96% of treatment-naive and 98% of experienced patients after 12 weeks of DCV+SOF. These positive results were also seen in genotype-2, -3 and -4 patients, with SVR at post-treatment week 12 reaching 100% (13/13), 100% (10/10) and 100% (3/3), respectively. Eight weeks of treatment appeared less effective with an SVR at 12 weeks post treatment of 76% in genotype-1 patients.
There were no treatment-related serious adverse events (AEs) and none of the patients stopped treatment due to AEs.
The results show that 12 weeks of DCV-SOF is a highly effective and well-tolerated treatment regimen for HCV in patients with HIV co-infection, including cirrhotic patients.
INFORMATION:
About The International Liver Congress™
This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Specialists share research studies and findings, and discuss the hottest topics related to liver disease. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. 2015 is a very special year for EASL and the hepatology community as they will celebrate the 50th annual meeting. The International Liver Congress™ takes place from April 22-26, 2015, Vienna, Austria.
About EASL
Since EASL's foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from more than 100 countries around the world. EASL is the leading liver association in Europe, it attracts the foremost hepatology experts and has an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.
Contact
For more information, please contact the ILC Press Office at:
ilc.press@easloffice.eu or
+44 (0)20 3580 5444
ELSE PRESS RELEASES FROM THIS DATE:
2015-04-23
April 23, 2015, Vienna, Austria: A new study presented today at The International Liver Congress™ 2015 shows that by using genomic analyses to understand how and when carcinogenic mutations occur in patients with hepatocellular carcinoma (HCC), it is possible to identify specific molecular profiles. It is hoped that these molecular profiles will help identify which patients would benefit from specific anticancer treatments.
Using exome sequencing - a technique for sequencing all the protein-coding genes in a genome - the study identified relationships between environmental ...
2015-04-23
April 23, 2015, Vienna, Austria: Results presented today at The International Liver Congress™ 2015 show that the use of the fixed-dose combination of ledipasvir/sofosbuvir (LDV/SOF) in combination with ribavirin (RBV) was well tolerated and demonstrated high sustained virologic response rates 12 weeks post treatment (SVR12) in patients with chronic hepatitis C virus (HCV) infection who have decompensated liver disease (cirrhosis) or have undergone liver transplantation.
SOLAR 2 data are presented for 328 HCV genotype-1 or -4 treatment-naive or treatment-experienced ...
2015-04-23
April 23, 2015, Vienna, Austria: Results revealed today at The International Liver Congress™ 2015 show that vitamin E (d-alpha-tocopherol) is an effective treatment for non-alcoholic steatohepatitis (NASH). NASH occurs when the liver becomes inflamed due to the accumulation of fat. Over time, persistent inflammation can lead to the formation of fibrous scar tissue in the liver and around its blood vessels, which can eventually cause cirrhosis.
A pooled analysis of data from two randomised trials comparing vitamin E versus placebo, and the placebo group from another ...
2015-04-23
April 23, 2015, Vienna, Austria: As many as half of people infected with viral hepatitis have suffered discrimination and one-quarter admit that family members have avoided physical contact with them after finding out they had the infection. A shocking patient survey presented at The International Liver CongressTM 2015 has shown the devastating impact the infection has on their daily lives.
Research conducted with the Ministry of Health in Brazil questioned 1,217 people infected with hepatitis B or C in Europe and America using an online survey tool. The aim of the research ...
2015-04-23
April 23, 2015, Vienna, Austria: Data presented today at The International Liver Congress™ 2015 demonstrates that remogliflozin etabonate, an investigational drug in type 2 diabetes, is a potential treatment option for the management of patients with non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD).
In clinical studies, remogliflozin etabonate was shown to significantly improve insulin sensitivity and beta cell function, as well as reduce body weight and levels of alanine aminotransferase (ALT). In pre-clinical studies, remogliflozin ...
2015-04-23
April 23, 2015, Vienna, Austria: New data from an ongoing Phase III trial revealed today at The International Liver CongressTM 2015 show that the use of hepatitis C immune globulin (HCIG, Civacir®) can effectively prevent hepatitis C virus (HCV) recurrence in patients following a liver transplant (LT). The data demonstrate that intravenous Civacir given both peri- and post-LT prevents HCV-reinfection in patients who also received antiviral therapy (AVT) before their transplant operation.
Civacir is a hepatitis C immune globulin (HCIG) produced from pooled plasma ...
2015-04-23
April 23, 2015, Vienna, Austria: Results from a double-blind, placebo-controlled study of silymarin, which is derived from the milk thistle plant, have shown that this herbal remedy may be a useful treatment option for non-alcoholic steatohepatitis (NASH).
An interim analysis of the study, revealed today at The International Liver Congress™ 2015, shows a significantly higher percentage of patients experienced NASH resolution and improvement in fibrosis after 48 weeks of treatment with silymarin compared to placebo.
NASH occurs when the liver becomes inflamed ...
2015-04-23
April 23, 2015, Vienna, Austria: Many countries in the World Health Organization (WHO) European Region are facing limitations in conducting chronic viral hepatitis disease surveillance, assessing the burden of disease and measuring the impact of interventions, according to results revealed today at The International Liver Congress™ 2015.
The study highlights that less than one-third (27%) of WHO European Member States have national strategies in place that contain a surveillance component. Furthermore, only 64% have a national surveillance system for chronic hepatitis ...
2015-04-23
April 23, 2015, Vienna, Austria: A new study revealed today at The International Liver CongressTM 2015 shows that sofosbuvir (SOF)-based regimens are effective and well tolerated in hepatitis C and HIV co-infected, cirrhotic patients. Sustained virologic response at 4 weeks (SVR4) was observed in 98% of patients and in 95% at 12 weeks (SVR12).
The results are particularly encouraging as this patient group is considered difficult-to-treat and has a high mortality rate. The study included 142 patients of different hepatitis C virus (HCV) genotypes who were initiated onto ...
2015-04-23
April 23, 2015, Vienna, Austria: Interim data presented today at The International Liver CongressTM 2015 from the HCV-TARGET study show that all-oral, direct-acting antiviral therapy for hepatitis C (HCV) is well tolerated and highly effective in patients with decompensated cirrhosis. Sustained virologic response (SVR) at 4 weeks was shown to be: sofosbuvir/ribavirin: 75%; sofosbuvir/simeprevir: 77%; sofosbuvir/simeprevir/ribavirin: 81%.
These results demonstrate that all-oral, direct-acting antiviral regimens are better tolerated and achieve higher rates of SVR in HCV ...
LAST 30 PRESS RELEASES:
[Press-News.org] Daclatasvir-sofosbuvir combination highly effective and well tolerated in patients with hepatitis C
Results from ALLY-2 confirm drug was well tolerated and effective across genotypes 1-4
