One in four patients with HCV denied initial request for treatment

A new study published in PLoS ONE showed that one in four patients with hepatitis C virus infection who apply for treatment of the infection is initially denied.

“Delay in access may further challenge our ability to cure hepatitis C in this country,” Joseph K. Lim, MD, associate professor of medicine and director of the Yale Viral Hepatitis Program at Yale University, said in a press release. “Some patients are told they must wait until they have advanced liver disease before they can undergo potentially curative treatment. We hope these data may help inform national policy discussions on promoting more rational, patient-centered approaches to HCV treatment access.”

“This is the first study to our knowledge assessing real-world access to interferon-free [direct-acting antiviral] regimens in established cohorts of patients with chronic HCV seeking antiviral therapy,” the researchers wrote. “These results contribute to the limited data available addressing proportion of patients successfully obtaining drug authorization through public and private insurance carriers, time to approval, and predictors for approval. … Further studies are warranted to investigate the impact of evolving drug authorization policies by Medicare/Medicaid and private payers on access to curative HCV therapies such as [sofosbuvir and ledipasvir].” – by Melinda Stevens.

Do A, et al. PLoS One. 2015;doi:10.1371/journal.pone.0135645.

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Children as young as 10 are getting tattoos illegally, without realising they risk catching HIV and hepatitis

Children as young as 10 are getting tattoos, shocking new figures have revealed.

A worrying number of youngsters are visiting illegal tattoo parlours, unaware it is against the law for them to be inked before they are 18.

And half admitted to being unaware of the risk of infection from HIV and hepatitis.

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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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