Results from a new study demonstrate that chronic hepatitis C virus (HCV) infection is associated with a higher risk of developing cardiovascular diseases and significantly increases cost of care and length of time in hospital. Based on these results, revealed today at The International Liver Congress 2015, study investigators conclude that chronic HCV infection should be considered a risk factor for the development of cardiovascular diseases.
In the study, inpatient prevalence of diagnosed HCV infection was 1.9%. For these patients, the adjusted odds ratio (OR) for acute myocardial infarction was 2.29 (CI: 2.22?2.36); for coronary artery disease: 1.88 (CI: 1.83?1.93); for cerebrovascular accident: 1.98 (CI: 1.93?2.04) and for congestive heart failure: 1.08 (CI: 1.06-1.10).
In this study, patients with HCV infections were characterized using the weighted 2011 Nationwide Inpatient Sample (NIS) data.
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Thursday, April 23, 2015
EASL 2015: Daclatasvir-sofosbuvir treatment highly effective in patients with HCV and HIV co-infection
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).
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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).
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Merck Announces Results from Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney Disease
C-SURFER Trial is First to Investigate an All-Oral Ribavirin-Free Hepatitis C Treatment Regimen in Treatment-Naïve and Treatment-Experienced Patients with Advanced Chronic Kidney Disease Infected with Hepatitis C Virus Genotype 1
VIENNA--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentation of data from C-SURFER, the company’s Phase 2/3 clinical trial evaluating the investigational once-daily treatment regimen of grazoprevir (100mg) and elbasvir (50mg) in patients with advanced chronic kidney disease (CKD) infected with chronic hepatitis C virus (HCV) genotype 1 (GT1).1 Treatment-naïve patients and patients who failed prior pegylated interferon HCV therapy, with or without cirrhosis, all of whom had CKD stages 4 or 5, were enrolled.2 Following 12 weeks of treatment with grazoprevir and elbasvir, 99 percent (115/116) of patients in the pre-specified primary population for analysis of efficacy data achieved a sustained virologic response 12 weeks after the completion of treatment (SVR12).3 These data will be presented today at The International Liver CongressTM 2015 – the 50th annual congress of the European Association for the Study of the Liver (late breaking E-Poster #LP02).
“There is an unmet medical need to treat chronic hepatitis C virus infection in patients with advanced chronic kidney disease,” said Dr. Howard Monsour, Jr., chief of hepatology, Houston Methodist Hospital, Houston, Texas. “In this trial, the first to investigate an all-oral ribavirin-free treatment regimen in treatment-naïve and treatment-experienced CKD patients, treatment with grazoprevir and elbasvir for 12 weeks was effective in this study population with HCV genotype 1 infection.”
The ongoing C-SURFER Phase 2/3 clinical trial is a randomized, parallel-group, placebo-controlled study evaluating patients infected with chronic HCV GT1 with advanced CKD with or without liver cirrhosis. Patients were randomized to one of two study arms:
- Immediate treatment group (ITG), grazoprevir plus elbasvir (blinded) once-daily for 12 weeks (n=111);
- Deferred treatment group (DTG), initially placebo (control arm) for 12 weeks followed by a four week follow-up period and then treatment with grazoprevir plus elbasvir (open label) once-daily for 12 weeks (n=113).
Of the 122 patients who received grazoprevir plus elbasvir, 83 percent were treatment-naïve, 36 percent had diabetes, 18 percent had stage 4 CKD, 82 percent had stage 5 CKD, 75 percent were receiving hemodialysis and 45 percent were African-American. Among those patients who received at least one dose of grazoprevir plus elbasvir, five percent (6/122) were excluded from the pre-specified primary efficacy analysis population, or modified full analysis set, due to missing data caused by death or early discontinuation for reasons unrelated to study drug. In the modified full analysis set, 99 percent (115/116) of patients receiving grazoprevir plus elbasvir achieved SVR12. One GT1b infected, non-cirrhotic, interferon-intolerant patient showed a viral relapse at follow-up week 12. Within the modified full analysis set, efficacy was consistent across the patient sub-populations assessed. In a supportive analysis of all 122 patients who received at least one dose of grazoprevir plus elbasvir in the ITG arms, including patients who did not complete the study for reasons not related to study drug, 94 percent (115/122) of patients achieved SVR12.
“Merck’s broad clinical development program includes studies dedicated to bringing a once-daily regimen to diverse populations of patients infected with chronic HCV, including certain types of patients with co-morbidities, such as advanced chronic kidney disease,” said Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories. “These data highlight how emerging innovations in chronic hepatitis C treatment may lead to new options for patient populations in which it historically has been difficult to achieve high rates of sustained viral clearance.”
No patients in the ITG arms discontinued treatment due to adverse events (AEs), while four percent (5/113) of patients in the comparator placebo phase of the DTG arm discontinued treatment due to AEs. The rates of serious AEs reported were 14 percent (16/111) in the ITG arms and 17 percent (19/113) in the placebo control DTG arm. The most common treatment-related AEs in the ITG arms and DTG arm (placebo) were headache (17%, 17%), nausea (15%, 16%) and fatigue (10%, 15%), respectively. There were four deaths reported during the initial treatment phase and the first 14 days of study follow-up. One patient (1%) in the open label arm died from cardiac arrest (not considered related to study medicine) and three patients (2%) in the placebo group died from aortic aneurysm, pneumonia and an unknown cause.
On April 8, 2015, the company announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy designation to grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT1 with end-stage renal disease on hemodialysis and patients infected with chronic HCV GT4. Breakthrough Therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
About C-SURFER
C-SURFER is a Phase 2/3 clinical trial evaluating Merck’s investigational grazoprevir plus elbasvir in patients infected with chronic HCV GT1 and with advanced chronic kidney disease (stages 4 and 5, including patients on hemodialysis) with or without liver cirrhosis, which are among those with HCV infection who are most difficult to treat, over 12 weeks.
About Chronic HCV Infection and Chronic Kidney Disease
Chronic HCV infection is both a cause and complication of the treatment of CKD. In patients with CKD, chronic HCV infection is associated with an increased risk of accelerated loss of remaining kidney function, kidney transplant failure and death. Furthermore, patients with chronic HCV infection and advanced CKD represent an unmet need due to a lack of demonstrated HCV treatment options for this group.
About Grazoprevir/Elbasvir
Grazoprevir/elbasvir is an investigational, once-daily single tablet regimen consisting of grazoprevir (NS3/4A protease inhibitor) and elbasvir (NS5A replication complex inhibitor). As part of Merck’s broad clinical trials program, grazoprevir/elbasvir is being studied in multiple HCV genotypes and in patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, liver cirrhosis and those on opiate substitution therapy.
Read complete press release here...
Wednesday, April 22, 2015
U.S.A-$373.9 Billion Spent on Drugs in 2014
“Drug spending in the United States last year was one for the record books. Pharmacists filled a record 4.3 billion prescriptions in 2014 that cost nearly $374 billion, according to a new report issued by the IMS Institute for Healthcare Informatics.
The 13.1% increase in drug spending in 2014 was mainly driven by two things: the availability of new hepatitis C [HCV] treatments and very few products losing patent protection,” said Murray Aitken, IMS Health senior vice president and the executive director of the IMS Institute for Healthcare Informatics. “Sovaldi [sofosbuvir; Gilead] was the biggest drug launch in history and accounted for about $8 million, or 2%. of the 13% increase.
As for patent protection, the health system saves money when drugs move from branded products to generics. Typically, there has been a savings of between 15 [billion] and 30 billion a year due to patent expiries. But in 2014, that figure was only $12 billion,” he said”.
EASL Recommendations on Treatment of Hepatitis C 2015
The European Association for the Study of the Liver has issued new guidelines for hepatitis C.
These EASL Recommendations on Treatment of Hepatitis C are intended to assist physicians and other healthcare providers, as well as patients and other interested individuals, in the clinical decision-making process by describing the optimal management of patients with acute and chronic HCV infections.
Several versions of the Guidelines in pdf form can be found here
These EASL Recommendations on Treatment of Hepatitis C are intended to assist physicians and other healthcare providers, as well as patients and other interested individuals, in the clinical decision-making process by describing the optimal management of patients with acute and chronic HCV infections.
Several versions of the Guidelines in pdf form can be found here
Arkansas: State panel OKs more hepatitis-C drug buys
More teachers and state employees with hepatitis-C will be eligible for treatment with expensive drugs under changes adopted by a state board on Tuesday.
The changes approved by the State and Public School Life and Health Insurance Board broadened criteria for the treatment that the board set just over a month ago for coverage of the drugs, which can cost more than $86,000 for a 12-week course of treatment.
The changes will also allow most patients who meet the criteria to take a drug regimen that does not involve injections of interferon, which can cause flulike side effects.
Gilead uses Georgia as free-drug testbed for hepatitis C elimination
(Reuters) - Gilead Sciences is seeking to convince governments and multilateral agencies worldwide that hepatitis C can be eliminated with a demonstration project in Georgia offering free drugs to all those who need them.
The unprecedented program will make the Caucasian country a testbed for uprooting the liver-destroying disease, using Gilead's highly effective but costly pill Sovaldi, plus its newer product Harvoni once approved.
Georgia has the world's third highest prevalence of hepatitis C, after Egypt and Mongolia, with nearly 7 percent of adults carrying the virus. It also has a wide range of viral variations and different types of patients.
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