Cambridge biotech gets funding for development of hepatitis C vaccine

As several biotechs focus on developing lucrative hepatitis C drugs, a Cambridge firm has received funding to help develop a hepatitis C vaccine.

VBI Vaccines (Nasdaq: VBIV) has secured $6.29 million from a variety of venture capital investors, including new investor RTW Investments, with participation from ARCH Venture Partners and Perceptive Advisors.

Under the terms, VBI sold 3 million shares of stock at approximately $2 a share, resulting in the raise.

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Health ministry approves new hepatitis C drug under insurance scheme

A health ministry panel has added a new highly effective, but expensive, hepatitis C virus drug to the national health insurance scheme, giving high hopes for patients who have had to endure painful interferon injections.

The tablet drug Harvoni, developed by U.S.-based Gilead Sciences Inc., is expected to revolutionize the treatment of patients with hepatitis C genotype 1, which accounts for about 70 percent of all hepatitis C patients in Japan.

A daily dose of one pill set at ¥80,171 will starting Monday be covered by the insurance, limiting the patient cost to about ¥20,000 a month. Read more.... Read our Hepatitis C Around the World on Japan: go here....

One in four hepatitis C patients denied initial approval for drug treatment

Nearly one in four patients with chronic hepatitis C (HCV) are denied initial approval for a drug therapy that treats the most common strain of the infection, according to a Yale School of Medicine study.

The finding, published Aug. 27 in PLOS ONE, identifies a new barrier to caring for patients with this severe condition.

Prior to the FDA approval of novel antiviral therapies for HCV in 2014, treatment options for patients were limited, requiring weekly injections of interferon-based therapy that caused severe side effects. The new regimens revolutionized treatment and offered patients an oral therapy with cure rates exceeding 90%. However, the high cost of care led insurers to impose new restrictions on drug authorization. Read more....

Should We Be Rationing Hepatitis Drugs? Obama Pressured to End Restrictions

Amid mounting evidence that federal and state authorities are rationing costly new wonder drugs for treating people with the potentially lethal hepatitis C virus, public health experts have begun pressing the White House to intervene to expand the use of Sovaldi and other new medications.

An estimated 3.2 million adults are chronically infected with hepatitis C while an estimated 20,000 people die from the serious liver ailment every year, including many military veterans.

The New York Times reported on Tuesday that a group of experts from the Public Health Service and President Obama’s Advisory Council on H.I.V./AIDS wrote a letter to the White House complaining that restrictions on the use of these drugs by many states are inconsistent with prudent and sound medical practices. Read more....

HCV infection associated with hardening of the coronary artery

"A higher HCV load was associated with more extensive plaque formation."

Chronic hepatitis C virus (HCV) infection is associated with an important early warning side of cardiovascular disease, investigators from the Multicenter AIDS Cohort Study (MACS) report in the online edition of the Journal of Infectious Diseases. Both HIV and HCV infections were independently associated with hardening of the coronary artery, but there was no evidence that HIV/HCV co-infection worsened atherosclerosis. After controlling for HIV infection and other factors associated with heart disease, a consistent relationship was present between chronic HCV infection and coronary artery plaque formation.

“This is the largest study to date to demonstrate that chronic HCV [CHC] infection is associated with subclinical coronary atherosclerosis, an important predictor of future cardiovascular disease [CVD],” write the authors. “The association of CHC with plaque remained significant after adjustment for…recognized CVD risk factors and was independent of HIV infection.”

“The elevated prevalence of subclinical coronary atherosclerosis among men with chronic HCV infection, especially men with the highest HCV RNA levels, provides further evidence supporting a link between chronic HCV infection and cardiovascular disease,” conclude the authors. “The presence of HCV infection may warrant vigilant cardiovascular risk assessment in these patients.”

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Cure Hep C and You May See Your Liver Health Improve

Among those coinfected with HIV, a cure for hepatitis C virus (HCV) is linked with improvements in liver stiffness, even if they have cirrhosis, aidsmap reports. Publishing their findings in the journal AIDS, researchers studied 98 HIV/HCV-coinfected individuals who had taken at least one dose of hep C therapy.

Fifty-three members of the cohort (54 percent) achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure).

The median follow-up time for the entire study group was 45 months.

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Op-Ed How to pay the bill for hepatitis C

"California...is helping to lead the way out of the hepatitis C conundrum with a sensible policy: Treat everyone who needs it, but not until treatment is necessary."

How long should you wait to treat a possibly fatal but curable disease?

That's a question with major implications for millions of patients and for insurers and government programs that have to pay for the treatment.

In the last year this question has focused on hepatitis C, a viral infection of the liver that, left untreated, can lead to cirrhosis, cancer, liver failure and death. Hepatitis C is the leading cause for liver transplants in the United States.

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