FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data

File this under ‘Show me the data.’

A pair of public health advocacy organizations has filed a lawsuit against the FDA, claiming the agency failed to release clinical trial data for Gilead Sciences GILD -3.38%’ hepatitis C treatments on a timely basis. And the move is only the latest installment in an ongoing drama in which researchers and patient advocates have tussled with drug makers and regulators over access to such information.

Here’s what happened:

Late last year, Treatment Action Group and the Global Health Justice Partnership asked Gilead for patient-level trial data for the Sovaldi and Harvoni drugs. They sought the data because the drugs are widely prescribed, thanks to very high cure rates, and because the FDA approved the drugs as part of a regulatory process known as a breakthrough designation, which accelerated review.

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National study finds life-threatening barriers in access to breakthrough drugs

Most states violate federal Medicaid law because they deny coverage for sofosbuvir, a new and highly effective treatment to cure hepatitis C, according to Lynn E. Taylor, M.D., director of The Miriam Hospital's HIV/Viral Hepatitis Coinfection Program. Taylor's team of researchers examined Medicaid policies for hepatitis C virus treatment using sofosbuvir, more commonly known as Solvadi, and found that most should change policy to improve access to the treatment. The study and its findings were published online in advance of the August issue of the Annals of Internal Medicine.

Hepatitis C virus affects over three million Americans. Worldwide, an estimated 120 to 150 million people have chronic hepatitis C. Left untreated, the infection can lead to cirrhosis, liver failure, and liver cancer. Sofosbuvir is a highly effective pharmaceutical used in combination with other medications to cure the disease.

Taylor's research team, which included the Harvard Law School Center for Health Law and Policy Innovation, Treatment Action Group, Kirby Institute of Australia, and Brown University, found that most Medicaid coverage restrictions for sofosbuvir violate federal Medicaid law, which requires states to cover drugs consistent with their U.S. Food and Drug Administration (FDA) labels.

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What's behind fatigue, elevated liver enzymes?

'I'm more tired than usual, doctor," the patient said, though she really thought nothing was wrong. At 60, she assumed age was catching up with her, and was at the doctor's office for her routine checkup.

Indeed, all her blood work was normal - except for the panel revealing elevated liver enzymes. A liver ultrasound suggested the damage had been going on for some time.

Aside from hypertension, she had no other active medical conditions. The only drugs she took were a diuretic and a multivitamin.

Read more at http://www.philly.com/philly/health/20150628_What_s_behind_fatigue__elevated_liver_enzymes_.html#afUCSI50z4BEYo88.99

Madison County plans 4 sites for needle-exchange program - SFGate

ANDERSON, Ind. (AP) — Health officials are working to open four needle-exchange sites in a central Indiana county after being granted state approval for the program because of disease being spread among intravenous drug users.

The Madison County Health Department wants to have the sites open by late July or early August — two in Anderson and one each in Alexandria and Elwood.

People using the program will have access to other services at each site, such as substance abuse treatment programs and assistance in obtaining food and housing, county public health coordinator Stephanie Grimes told the Herald Bulletin

Madison County plans 4 sites for needle-exchange program - SFGate

ASCO 2015: Does Hepatocellular Carcinoma Differ in People with Hepatitis B and C? | Liver Cancer/HCC

 Liver cancer patients with hepatitis B at a large U.S. cancer center appeared to have worse disease status than those with hepatitis C, including larger tumors and more extensive liver involvement, according to research presented at the American Society of Clinical Oncology (ASCO) annual meeting this month in Chicago. Prognosis for the 2 groups was similar, however.

Over years or decades chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection can lead to serious liver disease including cirrhosis and hepatocellular carcinoma (HCC), a type of primary liver cancer. HCC is a major cause of cancer death worldwide, and hepatitis B and C are leading risk factors. But it is not well understood how liver cancer outcomes differ for people with HBV (a DNA virus in the Hepadnavirus family that integrates its genetic material into host cells) versus HCV (an RNA virus in the Flavivirus family).

hivandhepatitis.com - ASCO 2015: Does Hepatocellular Carcinoma Differ in People with Hepatitis B and C? | Liver Cancer/HCC

Bristol-Myers Squibb Co Undergoes Major US Business Revamp

Bristol-Myers Squibb Co (NYSE:BMY) announced Thursday it will be halting early-stage discovery work in virology research, including hepatitis B and HIV. The company will be laying off around 100 employees as it shuts down two research centers.

"Consistent with the evolution of the company's R&D strategic focus, which was announced in 2013, the Discovery organization will discontinue its research efforts in virology. This includes early research in hepatitis B (HBV) and HIV...Approximately 100 Discovery positions will be eliminated as a result of these changes,” the company stated.

Bristol-Myers, however, noted that ongoing development work on advanced virology treatments including HIV attachment inhibitor BMS-663068, the HIV maturation inhibitor BMS-955176, beclabuvir and the anti-PD-L1 compound BMS-936559, will continue. Also, the company’s marketed virology drugs such as Baraclude (entecavir), Reyataz (atazanavir)/Evotaz (atazanavir and cobicistat), Sustiva (efavirenz), Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate), Daklinza (daclatasvir) and Sunvepra (asunaprevir), will not be affected by the consolidation.

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Liver transplants in HIV/HCV co-infection: study underlines importance of hepatitis C treatment

People with HIV and hepatitis C co-infection were significantly more likely to experience organ rejection than people with hepatitis C alone or HIV alone after undergoing a liver transplant, according to a review of 11 years' experience of liver transplantation in people with HIV and with hepatitis C virus (HCV) in the United States, published in advance online in the journal Clinical Infectious Diseases.

The study investigators say that their findings underline the importance of treating hepatitis C either before or immediately after liver transplantation in order to improve outcomes, rather than assuming that people with co-infection will have poorer outcomes based on historical data.

Liver transplantation remains a relatively rare procedure among people living with HIV, due in part to concerns about poorer survival and higher rates of organ rejection in people with HIV. Although a study carried out by the United States National Institutes of Health (NIH) showed a somewhat lower rate of survival three years after transplantation and a higher rate of organ rejection in people with HIV and hepatitis C co-infection compared to people with hepatitis C alone (mono-infection), the majority of transplants in each group was successful. The success of transplantation in people with HIV who are not do not have hepatitis C co-infection has been unclear. Furthermore, data are lacking outside the clinical trial setting regarding the outcomes of transplants in people with co-infection, particularly at transplant centres which did not take part in the NIH trial.

Reference

Sawinski D et al. Beyond the NIH Multicenter HIV Transplant Trial experience: outcomes of HIV+ liver transplant recipients compared to HCV+ or HIV+/HCV+ co-infected recipients in the United States. Clin Infect Dis, advance online publication, 16 June 2015.

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