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The introduction of direct-acting antivirals has potentially contributed to a reduction by a third in the number of HCV-related referrals for liver transplant, according to two US studies presented at the recent 2015 AASLD Liver Meeting. A related French study also found a decrease in waiting list numbers, although this was approximately half that observed in the US study.
Bristol-Myers Squibb Co. has signed a broad agreement with the Medicine's Patent Pool (MPP), the world’s only voluntary licensing mechanism in public health, allowing the United Nations-backed organisation to distribute licenses for generic-drug companies to copy its hepatitis C treatment daclatasvir in more than 100 developing and middle-income nations. Nearly two-thirds of all patients living with hepatitis C in these countries reside in the territory covered by this agreement. The licence allows the generics manufacturers to produce copies of the drug without paying any royalties.
The agreement allows drug manufacturers to be based anywhere in the world, and for generic daclatasvir to be manufactured in any country. Daclatasvir, however, must be for sale in the 112 countries covered by the agreement. The licence gives generic manufacturers the crucial ability to develop fixed-dose combinations with other direct-acting antivirals to create pan-genotypic regimens which can potentially treat all of the six major genotypes of HCV. Such regimens are critical in countries with limited resources, which restricts access to genotype testing.
Hepatitis C affects up to 150 million people worldwide, most of whom live in low and middle-income nations. “This agreement could change the lives of millions of people with hepatitis C,” said Dr. Margaret Chan, WHO Director-General. “It’s a vital step towards ensuring essential treatments are available to all who need them, both rich and poor.”
The licensing agreement between Bristol-Myers Squibb and MPP follows MPP’s announcement of its mandate expansion to hepatitis C and tuberculosis medicines. MPP’s proposals to improve access to life-saving direct acting antivirals (DAAs) for hepatitis C were approved by the UNITAID Executive Board.
UNITAID’s Deputy Executive Director, Philippe Duneton, said: “We are very pleased to see that the recent decision of the UNITAID board to support the work of MPP in the HCV space has made possible the conclusion of an agreement opening the way to wider access to effective medicines against HCV among those in need.”
An 18-month US Senate Finance Committee investigation into the pricing of hepatitis C drugs Sovaldi and Harvoni has accused drugs manufacturer Gilead Sciences of prioritising company profits over widening patient access.
The investigation found that the vast majority of over 700,000 patients with hepatitis C are still awaiting treatment through state Medicaid programs. In 2014 Medicaid programs spent $1.3 billion before rebates on the hepatitis C medications, which treated fewer than 2.4 percent of patients. The report provided Indiana’s Medicaid program as an example, which spent $40 million to treat 462 people.
Senator Ron Wyden, announcing the findings of the investigation at a news conference, said, “It was always Gilead's plan to maximise revenue, and affordability and accessibility was an afterthought.”
Gilead has consistently defended the price of its medicines. In a statement responding to the conclusions of the report, Gilead said: “With the rebates and discounts now in place, the prices today are less than the cost of prior regimens.” It added that its treatments reduce the long-term costs associated with chronic hepatitis C, such as liver failure or the need for liver transplants.
Interviews conducted by HCV Next with manufacturers of hepatitis C treatments have offered an insight into manufacturers’ decisions on pricing strategy for drugs and combinations. Gilead has previously maintained that the prices of Sovaldi and Harvoni reflect the innovation of the medicines. AbbVie also pointed out the price of Viekira Pak reflects the value it brings to people living with hepatitis C and to the health care system.
Investigators from the United States have reported that effective treatment is urgently needed in patients with advanced liver fibrosis or cirrhosis. A study showed that over a third of patients with F4 stage liver fibrosis at baseline had developed hepatic decompensation or liver cancer. This data is in line with current policy decisions on which patients with hepatitis C should be prioritised for therapy and to improve access for these patients. Many countries are forced to prioritise treatment decisions due to health systems unable to afford the high cost of treatments.
Health ministers of the Mercado Común del Sur (MERCOSUR) and Associate States have completed initial negotiations with a number of pharmaceutical companies that will lead to the joint procurement of high-cost medicines, with the support of the Pan American Health Organisation/World Health Organisation (PAHO/WHO).
The first round of negotiations achieved lower prices for direct-acting antivirals (DAAs) used in the treatment of hepatitis C, as well as for HIV medicines. The mechanism for these type of negotiations to be replicated across Europe currently exists within European legislation, although this requires more joined-up working between national health systems.
An Australian support service has been established in response to the inability of the national health system to give full access to Hepatitis C treatment due to high medication costs.
The FixHepC Buyers Club has been started to assist patients in importing the life-saving medication from generic manufacturers for a fraction of the current prices. The service helps the buyer arrange the importation of the generic DAA from Chinese sources and also facilitates the testing of the drug to ensure its pharmaceutical equivalence to the original drug. Currently the drugs imported have included sofosbuvir, ledispavir and daclatasvir. The service is entirely legal and the site helpfully lists personal medication regulations for other countries such as the UK.
FixHepC spokesperson, Dr James Freeman, said “What we do take issue is the situation where only around 500,000 people have been treated during the same time period that 1,500,000 have been allowed to die in pursuit of super profits.
As clinicians our major concern in prescribing medication was the risk of the supply chain integrity being compromised. The Buyers Club eliminates that risk by having medication tested using Nuclear Resonance at a leading Australian University laboratory against baseline samples of the patented, regulatory approved product.”
An award-winning project undertaken by NHS Tayside to improve access to hepatitis C testing and treatment in community pharmacy for patients addicted to opioid drugs is set to be extended over the next few months. The project won a Quality in Care (QiC) Programme award for researching and developing a new pathway to test and treat these hard-to-reach patients, which makes use of their daily contact with community pharmacists to receive opioid replacement therapy (ORT).
Waverley Care’s African Health Project was presented the UK-wide nOscars award for its close collaboration with Africa communities to raise awareness of HIV, encourage testing and reduce new infections. The Health and Faith agenda was developed in recognition of the important role that African churches can play in increasing awareness around HIV testing and treatment.
New research from the University of Glasgow has found that the roots of hepatitis C infection in Scotland date back to the Second World War. The study shows that HCV entered Scotland during the 1930s and 1940s whilst also spreading to other countries throughout the world. The genetic mapping shows the path of the virus as it spread through communities. This type of mapping may allow better and more targeted interventions in future infectious outbreaks.
A recent study presented at the 2015 AASLD Liver Meeting suggests that the number of patients with HCV still using illicit drugs and/or alcohol poses a real challenge to scaling-up of HCV therapy in the UK.
New research presented at the 4th International Symposium on Hepatitis Care in Substance Users has determined that treating hepatitis C in people who inject drugs is the most cost-effective way to address the sharp increase in liver disease and death resulting from hepatitis C infection.
An unrelated study conducted by Merck has found that treating hepatitis C in people who use intravenous drugs has highly successful outcomes.
A new type of syringe designed to reduce HCV transmission may not be particularly effective at preventing the spread of hepatitis C, a study led by the Yale School of Public Health has suggested. The study found that the new low dead space design still retained small amounts of blood containing HCV that could potentially be infective.
Other research has previously suggested that utilising a reduced dead space syringe design could minimise the risk of other blood-borne pathogens such as HIV. These different findings may be related to the higher risk of infection from HCV compared to HIV as the hepatitis C virus is more concentrated in blood than HIV and can live significantly longer outside the body.
Evidence in a meta-analysis published in Plos One highlights that coffee consumption can have beneficial effects for liver-related diseases has been published. The protective effect of coffee on hepatic fibrosis and cirrhosis was also identified in subgroup meta-analyses of patients with alcoholic liver disease.
An unrelated study presented at the recent 2015 AASLD Liver Meeting found that coffee intake may reduce the risk of hepatocellular carcinoma (HCC) recurrence and improve survival following orthotopic liver transplantation (OLT).
The National Institute for Health and Care Excellence (NICE) has made recommendations for three additional high-cost medicines to be available to treat routine hepatitis C infection in certain patients.
The treatments will become available in England on the NHS within three months.
Figures from a report from Public Health England show that 1 in 8 injecting drug users (48%) were unaware of having hepatitis C and while uptake of testing for hepatitis C among injecting drug users is high about half of all infections are undiagnosed.
A survey conducted of 874 men in London who use drugs during sex has shown high levels of unprotected sex and hepatitis C among both HIV-positive and HIV-negative men who have sex with men, high levels of post-exposure prophylaxis use and a high frequency of injecting drug use.
A Drug and Alcohol Findings report has found that a holistic harm reduction strategy as well as improving treatment of infection is required to contain the current numbers affected by hepatitis C virus.
An analysis of data from various studies has concluded that a combination of harm reduction services such as methadone maintenance therapy and needle and syringe exchange programmes could reduce the risk of HCV by up to 80%. While treatment is also effective in reducing the overall prevalence of HCV and the risk of transmission, various studies show that resources need to be allocated to both harm reduction services as well as treatment in order to significantly reduce the risk of infection in the population.
— The US Food and Drug Administration (FDA) has approved Harvoni (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV. Harvoni with ribavirin (RBV) for 12 weeks was also approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis.
— Findings from an analysis of real-life hepatitis C treatment using direct-acting antiviral agents (DAAs) in the GECCO German hepatitis C cohort report that most people with hepatitis C virus treated with sofosbuvir/ledipasvir (Harvoni) for 8 weeks achieved sustained virological response, including those who were advised to stay on the treatment for 12 weeks due to factors such as liver cirrhosis, prior treatment experience or high HCV viral load.
— A study conducted for the Cochin Hepatology and Cardiology Group has reported three cases of severe bradyarrhythmia which occurred during treatment with sofosbuvir-based regimens.
— Research from the University of Birmingham has found that a drug, currently used to treat Type II diabetes, can be effective in tackling fatty liver disease in some patients.
— Women with chronic hepatitis B and high viral load were significantly less likely to transmit hepatitis B virus (HBV) to their babies when they were treated with tenofovir (Viread) during pregnancy. The findings came from a study presented at the AASLD Liver Meeting. Another study showed that women with hepatitis B often experience viral load or alanine aminotransferase (ALT) flares during pregnancy or post-partum.