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Welcome to the second part of a double edition of the Hepatitis Scotland e-Bulletin.
The US FDA has issued a warning to health care providers after 1 patient died and 8 others developed abnormally slow heartbeats when prescribed sofosbuvir containing medications alongside heart drug amiodarone. The company said the combinations are not recommended and that it will update its product labelling in due course.
Sofosbuvir was fast tracked through both US and European regulators. Amiodarone is not a commonly used drug (it is also contraindicated for those taking methadone) however investigators are unaware of the mechanism that caused the problems with sofosbuvir. This may have implications for the amount of clinical monitoring needed for the all oral regimes.
Bristol Myers Squibb's experimental drug BMS-986094, in the same drug class as sofosbuvir, was discontinued in 2012 due to unexplained cardiac problems amongst trial participants. In a story on medscape about theirretrospective study of the cardiac problems the lead investigator said their review also showed that patients who appear to be most at risk for developing systolic dysfunction were individuals with cardiovascular disease risk factors, such as hypertension or diabetes, and that these can be the type of patients who are excluded from clinical trials and who could be at risk when the drugs were used in the general population of HCV patients. He also acknowledged that with HCV trials often smaller than cardiology studies the cardiac effects of other nucleotide-polymerase inhibitors might simply be undetected at this point. The findings were thought important, particularly due to the inability to use traditional investigation techniques to gauge this type of myocardial dysfunction, other than with ultrasound.
Gilead Sciences new Hepatitis C treatment Harvoni (combination of sofosbuvir and ledipasvir) has been accepted for restricted use in Scotland by the Scottish Medicines Consortium, and recommended for use in England in draft guidance by NICE. The Scottish guidance restricts treatment with Harvoni to genotype 1 and 4 patients, although genotype 3 patients may be considered where they have either cirrhosis and/or previously failed to respond to interferon based treatment.
Research published in Hepatology has said that reducing drug prices is the key to providing universal access to Hepatitis C treatment across the world. The research sought to estimate the minimum costs of treatment with currently available and highly effective direct acting antivirals (DAAs) and associated monitoring across Hepatitis C genotypes, were large scale generic manufacture possible.
Achillion’s experimental Hepatitis C drug, ACH-3102, when used alongside Gilead’s sofosbuvir eradicated the Hep C virus in 6 weeks, making it the shortest duration and highest response achieved by any two drug treatment, according to the results of a recent study.
A study published in the Lancet has sought to demonstrate the efficacy and safety of all oral sofosbuvir plus ribavirin treatment for HCV/HIV co-infected patients. SVR rates after 12 weeks ranged from a low of 84% for genotype 4 up to a high of 95% for those with genotype 1. SVR rates remained high regardless of treatment experience or naivety.
This review published in Liver International summarizes the results obtained with oral direct acting antiviral combinations for Hepatitis C genotype 1 treatment naive patients that have either been approved or completed phase 3 clinical trials.
Research published in Drug and Alcohol Findings has provided evidence for an association between increased access to opiate substitution therapies and a decrease in drug related deaths and hospital admissions. Between 2000-2002 and 2004-2006 net drug related deaths across Sweden fell by about 12%.
New research has shown low serum levels of vitamin D are associated with clinically significant symptoms of depression in otherwise healthy individuals.
A research article published in Diabetic Medicine has documented the case of a 23 year old woman who developed type 1 diabetes after being initiated onto triple therapy (Peg Interferon, ribavirin + a protease inhibitor) for her Hepatitis C infection. The woman had an IL28B gene polymorphism which was associated with both antiviral therapy response but also with diabetes risk post liver transplant. The article concludes that more research is required to determine which characteristics may identify patients who are at risk of developing type 1 diabetes when treated with interferon based regimens for Hep C.
Research published in Alimentary Pharmacology and Therapeutics sought to clarify the association between Hepatitis C infection and an increased risk of post liver transplant diabetes. Using data from 17,000 HCV infected transplant patients it concluded that Hepatitis C infection was a greater risk for post liver transplant diabetes for up to 5 years after transplant.
A study published in the Journal of Gastroenterology has shown that integrated care for psychiatric or substance abuse problems in tandem with Hepatitis C treatment can increase rates of SVR. A randomized trial was conducted at 3 medical centres in the US and a mid level health professional was placed in each HCV clinic to provide integrated care with brief mental health interventions and case management according to formal protocol. Study participants suffered from a range of difficulties which can act as barriers to successful treatment for Hepatitis C including, psychiatric illness, homelessness, substance misuse problems, depression and post traumatic stress disorder. 80% had genotype 1 infection and 23% had advanced fibrosis.
31.9% of those receiving integrated care started treatment for HCV compared with 18.8% in the control group and 15.9% achieved SVR versus 7.7% in the control group. There were no differences in serious adverse events between the groups.
Two recently published studies (from Australia and the es) featured on National Aids Map (NAM) have shown that patients being treated for Hepatitis C have different motivations for wishing to clear the virus and that clinical feedback personalised to their individual needs throughout treatment may improve adherence and completion of treatment. This patient centrered approach to treatment is also covered in another US study just published - The Hepatitis C treatment experience: Patient perceptions of the facilitators of and barriers to uptake, adherence and completion.
Benitec biopharma has continued its clinical trial for its single dose Hepatitis C treatment, with a 4th patient having been dosed, with a 5th in the late stages of preparation. Aside from potentially curing Hepatitis C infection with a single dose, the treatment may also be able to prevent re-infection for months or even years after it is administered.
According to a study published in the Journal of Hepatology, HCC can still develop in Caucasian CHB patients treated with ETV/TDF. Besides the well-known predictors of HCC, such as older age, male gender and more advanced liver disease, lower platelets represent an independent factor of higher HCC risk.
Older adults who follow a mindful meditation program have improved sleep quality as well as less daytime fatigue and depression compared with their counterparts who take part in a sleep hygiene education (SHE) program, newresearch shows.