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This edition of the Hepatitis Scotland e-Bulletin focuses on recent research and news related to hepatitis treatment and testing.
After 3 cases in Japan of an increase in blood bilirubin levels of patients using Simeprevir being followed by hepatic dysfunction and/or renal impairment that led to death, a warning letter has been issued to physicians urging them to vigilantly monitor bilirubin levels. It is estimated nearly 19000 patients in Japan have had simeprevir as part of their HCV treatment.
An experimental Hepatitis C vaccine developed at Oxford University has shown promising results in an early clinical trial with strong and broad immune responses against the virus. 15 people took part in the phase 1 safety trial and the vaccine was found to be very safe and well tolerated. A further trial is now under way in the USA among IV drug users making it the first Hepatitis C vaccine to reach this stage of clinical trial.
The vaccines are designed to generate a strong T-cell immune response against Hepatitis C, as it is T-cells which seem to be important in people who naturally clear the virus.
Scottish Medical Consortium approves daclatasvir (Daklinza) for use in Scotland
The SMC has approved daclatasvir for use in combination with other medicinal products for treatment of Hepatitis C in adults. Use is restricted to patients with significant fibrosis scores (Metavir F3-F4) or compensated cirrhosis.
FDA approves Harvoni
The US Food and Drug Administration has approved the first combination drug to treat Hepatitis C, Gilead Sciences Harvoni. The drug is single pill which combines the company’s already approved sofosbuvir (marketed as Sovaldi) and ledipasvir.
Harvoni highly effective in cirrhosis patients
Gilead Sciences has announced data showing cure rates of 96% in a study of patients who had cirrhosis but had failed to benefit from prior treatments with their combination treatment Harvoni. The study involved 155 patients with cirrhosis and genotype 1 infection who had previously failed to achieve SVR using older interferon based regimens alongside protease inhibitors.
High Cure Rates for Genotype 3 using Daclatasvir and Sofosbuvir
The results of the study showed sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naïve and 86% of treatment-experienced GT3 patients.
European CHMP adopts positive opinion for Harvoni
The European Committee for Medicinal Products for Human Use has adopted a positive opinion for Harvoni. The recommendation will now be reviewed by the European Commission which will decide whether to grant marketing authorisation for its’ use across the EU.
NICE recommends simeprevir in draft guidance
The National Institute for Clinical Excellence has issued draft guidance recommending simeprevir in combination with peg interferon alfa and ribavirin for the treatment of genotype 1 chronic Hepatitis C in adults.
Simeprevir has received EMA marketing authorisation for treatment of genotype 1 and 4 chronic Hepatitis C but at this time NICE are not minded to recommend it for treatment of genotype 4 and has asked manufacturers Janssen for more information on its use for this group of patients.
Simeprevir gains FDA approval in combination with Sofosbuvir
Simeprevir (Olyssio) has now been approved by the FDA as a once daily all oral treatment for Hepatitis C in combination with sofosbuvir (Sovaldi) for treatment of genotype 1 HCV in adults.
Merck release positve phase 2 results
Treatment with grazoprevir plus elbasvir, both with and without ribavirin and for both 12 and 18 weeks' treatment duration, showed high rates of efficacy in previously untreated patients with cirrhosis and previous PR-null responders with and without cirrhosis.
Achillion Reports 100% SVR12 in a Phase 2 Study
100% SVR12 in Eight-Week Phase 2 trial evaluating a Ribavirin-Free regimen of ACH-3102 and sofosbuvir for Genotype 1 HCV with nine of 12 patients with viral loads higher than 6 Million IU/ml at baseline.
New clinical trial of Sofosbuvir in children
A researcher from St Louis University in the United States is to begin a study of treatment with sofosbuvir and ribavirin in children aged 3-17 with Hepatitis C. Sofosbuvir has now been licensed in many countries across the world for treatment of adults with Hepatitis C.
Patients with chronic hepatitis C virus infection and advanced fibrosis or cirrhosis who attained sustained virological response (SVR) had survival rates comparable with that of the general population, whereas patients who did not attain SVR had reduced survival rates, according to a study of 530 patients published in the November 12 issue of JAMA.
France takes action on Hep C drug pricing
The French Health Minister has announced French Government plans to selectively tax pharmaceutical companies producing Hepatitis C drugs in order to alleviate the burden of cost on the health system and ensure access to these drugs to all people who need it.
The government said it has designed a ‘progressive contribution scheme’ which selectively taxes these companies revenues above a 450 million Euros cap in 2014 and 700 million Euros in 2015.
Australia rejects sofosbuvir due to cost/benefit disparity
The Australian Pharmaceutical Benefits Scheme (the government department responsible for approving state funded medications) has rejected Gilead Sciences sofosbuvir (sovaldi) on the basis of ‘unacceptably high and likely underestimated cost effectiveness’ and the ‘high and likely underestimated budgetary impact on the PBS’.
Malaysian advocacy group calls for use of TRIPs for access to generic HCV drugs
In a letter to an online Malaysian news outlet, the Positive Malaysian Treatment Access and Advocacy Group and the Third World Network have called on the Malaysian Government to use provisions in the World Trade Organisation Agreement on Trade Related Aspects of International Property Rights (TRIPs), including compulsory licensing to ensure affordable access to new Hepatitis C drugs.
Questions over access to sofosbuvir in England
An article in the Independent newspaper has reported that NHS England may deny sofosbuvir to thousands of Hepatitis C patients based on cost – even if the drug is recommended by NICE (it has been provisionally recommended). An NHS England briefing has said that the estimated £1billion cost of providing the drug to 20,000 Hepatitis C patients was ‘prohibitive’ and that the NHS could halve the cost by prioritising patients according to severity of liver disease.
Cost effectiveness of sofosbuvir plus peg interferon and ribavirin in HCV genotype 1
A study published in Alimentary Pharmacology and Therapeutics has investigated the cost effectiveness of sofosbuvir plus peg interferon and ribavirin for treatment of Hepatitis C genotype 1 compared with other currently available treatments.
When compared to treatment with peg interferon and ribavirin (pegIFN/RBV), pegIFN/RBV + boceprevir, pegIFN/RBV + telaprevir and simeprevir + pegIFN/RBV sofosbuvir was typically associated with the lowest 1 year cost per SVR. Considering the lifetime incremental cost per quality- adjusted life-year gained, sofosbuvir + pegIFN/RBV was the most cost effective treatment option assessed.
‘Pay if you clear’ offer from Janssen to Scotland
Pharmaceutical company Janssen have made a unique offer to NHS Scotland that would see the NHS reimbursed if people fail to clear Hepatitis C after a 12 week course of the company’s new drug Olysio (simeprevir), which was recently cleared for use in Scotland by the Scottish Medicines Consortium.
Healthcare professionals working to improve the quality of care for Hepatitis C patients have been honoured at the inaugural Quality in Care (QiC) Hepatitis C Awards at British Association for the Study of the Liver (BASL) conference in Gateshead.
Among the winners were NHS Tayside for its’ work in providing access to Hepatitis C treatment to people who are actively injecting drugs and Dundee CHP for its’ work to improve outcomes for people with blood borne viruses in Dundee.
Parliamentary motion on Hep C
Kevin Stewart, SNP MSP for Aberdeen Central recently raised the issue of Hepatitis C in Scottish Parliament when he submitted a motion for debate.
A recent study published in the online edition of Clinical Infectious Diseases has shown that Hepatitis C core antigen testing may be as accurate as PCR testing in diagnosing acute Hepatitis C in people living with HIV. Compared with PCR testing, core antigen testing proved sensitive (100%) and specific (97.9%).
Another study published in the same journal has shown that whilst most HIV patients were screened for Hepatitis C at enrolment in care, only half of those who were not infected were screened again.
A legal firm is conducting an investigation into Arrowhead pharmaceuticals to determine whether they gave misleading statements as to the true efficacy of their Hepatitis B treatment ARC-520, which had previously been hailed as a 'functional cure'.
However, Arrowhead Chief Executive Chris Anzalone has written a letter to investors defending the treatment and the communications around it, saying that the results are strong and that increased dosage might provide the efficacy investors were looking for.
A team of Stanford university graduates have won an international competition for developing a mobile phone test for Hepatitis B. A diagnostic strip is used to take a finger prick of blood which flows into a tiny chamber and mixes with magnetic nanoparticles to form magnetically tagged biomarkers.
The test strip is inserted into a small magnetic detector, into which a smart phone is plugged and it's micro processor performs a Hepatitis B antigen test. The process only takes a few minutes.