Month: October 2016

Permitting PCPs to prescribe DAA therapy ‘in public health’s best interest’

Several states require that direct-acting antiviral medications for hepatitis C virus infection for Medicaid beneficiaries be prescribed by “specific provider types” — including infectious disease specialists, gastroenterologists, hepatologists and liver transplant specialists, according to CMS.

trooskinInfectious Disease News spoke with Stacey B. Trooskin, MD, PhD, director of viral hepatitis programs at Philadelphia Fight, about this specific Medicaid restriction, and whether specialized medication prescriptions from primary care providers should be covered by Medicaid.

If a provider is well-versed in the data and the literature and has experience treating HCV, it is in public health’s best interest to allow that provider to prescribe specialized medications.

This is particularly important in a resource-limited setting. For example, in rural environments there are often not enough specialists to provide subspecialty services and prescribe HCV medications to those in need. In those circumstances, it is critical that primary care physicians become trained in prescribing these medications, thereby making curative treatment accessible to patients living in rural environments.

There is definitely a need to expand treatment. We have seen the success of these models, particularly the ECHO model — Sanjeev Arora, MD, has published extensively on the success of PCPs providing HCV treatments in resource-limited settings with guidance and mentoring from subspecialty experts. This is an excellent way to train PCPs to become comfortable with using direct-acting agents.

Disclosure: Trooskin reports receiving grant funding from and serving in advisory positions for Gilead Sciences.

*Photo courtesy of Lorelei Narvaja

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LA County changes policy, will provide hepatitis C treatment to IV drug users

The Los Angeles Department of Health Services will start approving hepatitis C drugs for active IV drug users, the department’s chief medical officer has told KPCC. Until now, the department had withheld approval for anyone who had not been drug-free for at least six months.

The policy change comes after KPCC reported in August that L.A. County’s guidelines regarding IV drug users were more restrictive than those of the state’s Medi-Cal program.

Most people become infected with hepatitis C by sharing needles or other IV drug equipment. Acknowledging this, Medi-Cal expanded its treatment guidelines last year to include active IV drug among those considered eligible for hepatitis C drugs. Medi-Cal covers the cost of drugs for this population.

This summer, Dr. Hal Yee, the Department of Health Services’ chief medical officer, defended the county’s decision to not provide hepatitis C treatment to IV drug users.

“We believe it is likely that patients who are not using drugs are more likely to complete the treatment than people who are actively using illicit drugs,” Yee said at the time. He said very few IV drug users had requested hepatitis C treatment.

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Did you know hepatitis B is an STI?

102616-su2h-hbv-stiAfter the skin, the liver is the body’s second largest organ. It is situated on the right-hand side of the stomach and has around 500 functions, the most important of which is to detoxify the body.

Largely spread by viruses

The word hepatitis is made up of “hepar”, the Greek word for liver, plus the Latin suffix “itis” which means inflammation. Hepatitis therefore means inflammation of the liver. It can heal on its own, or progress to fibrosis (scarring), cirrhosis or even liver cancer and eventually death.

The condition is most commonly spread by viruses, but can also be caused by other infective agents, as well as toxic substances (e.g. alcohol, drugs) and autoimmune diseases.

There are five main hepatitis viruses, types A, B, C, D and E. The most serious types are A, B and C.

Hepatitis A is mainly spread through food and drink, hepatitis B by means of sexual contact, and hepatitis C through blood (for example when people share drug needles).

Hepatitis B is therefore the only form that is mainly spread through sexual contact.

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Scientists uncover why hepatitis C virus vaccine has been difficult to make

SCIENCE DAILY

Researchers have been trying for decades to develop a vaccine against the globally endemic hepatitis C virus (HCV). Now scientists at The Scripps Research Institute (TSRI) have discovered one reason why success has so far been elusive.

Using a sophisticated array of techniques for mapping tiny molecular structures, the TSRI scientists analyzed a lab-made version of a key viral protein, which has been employed in some candidate HCV vaccines to induce the body’s antibody response to the virus. The researchers found that the part of this protein meant as the prime target of the vaccine is surprisingly flexible. Presenting a wide variety of shapes to the immune system, it thus likely elicits a wide variety of antibodies, most of which cannot block viral infection.

“Because of that flexibility, using this particular protein in HCV vaccines may not be the best way to go,” said co-senior author TSRI Associate Professor Mansun Law.

“We may want to engineer a version that is less flexible to get a better neutralizing response to the key target site and not so many off-target responses,” said co-senior author Ian A. Wilson, TSRI’s Hansen Professor of Structural Biology and a member of the Skaggs Institute for Chemical Biology at TSRI.

The report, published online ahead of print by the Proceedings of the National Academy of Sciences the week of October 24, 2016, is likely to lead to new and better HCV vaccine designs.

A Great Need

A working vaccine against this liver-infecting virus is needed desperately. HCV infection continues to be a global pandemic, affecting an estimated 130 to 150 million people worldwide and causing about 700,000 deaths annually from liver diseases including cancer. Although powerful antiviral drugs have been developed recently against HCV, their extremely high costs are far beyond the reach of the vast majority of people living with HCV infection. Moreover, antiviral treatment usually comes too late to prevent liver damage; HCV infection is notorious for its ability to smolder silently within, producing no obvious symptoms until decades have passed.

The Law and Wilson laboratories have been working together in recent years to study HCV’s structure for clues to successful vaccine design. In 2013, for example, the team successfully mapped the atomic structure of the viral envelope protein E2, including the site where it binds to surface receptors on liver cells.

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Chronic Hepatitis B, C Linked With Non-Hodgkin Lymphoma in HIV Patients

NewsOctober 25, 2016Hematologic Malignancies, Leukemia & Lymphoma

Chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) was associated with an increased risk for non-Hodgkin lymphoma among patients with HIV who are on antiretroviral therapy, according to the results of a study published in Annals of Internal Medicine.

“Early diagnosis and treatment of HIV infection in conjunction with routine screening for chronic HBV and HCV infection is essential to further decrease non-Hodgkin lymphoma morbidity and mortality in HIV-infected persons,” wrote Qing Wang, PhD, from Basel Institute for Clinical Epidemiology & Biostatistics at University Hospital Basel in Switzerland, and colleagues. “Our findings provide strong evidence that HCV co-infected patients with poor immune status or restoration are at high risk for non-Hodgkin lymphoma and death and deserve high priority for access to well-tolerated, interferon-free, direct-acting antiviral treatment programs similar to those for patients with advanced liver fibrosis or cirrhosis.”

Wang and colleagues investigated whether chronic HBV or HCV was associated with increased incidence of non-Hodgkin lymphoma in patients with HIV. They looked at data from 18 of 33 cohorts from the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) for patients with HIV and information on HBV surface antigen measurement and detectable HCV RNA, or a positive HCV antibody test.

Of 52,479 treatment-naive patients, they identified 1,339 with HBV (2.6%) and 7,506 with HCV (14.3%); 0.4% of patients had dual infection. Seventy-seven percent of these patients later started antiretroviral therapy.

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New Reason Your Patients With HCV Will Say ‘Thanks a Latte’

COMMENTARY

Hello. I am Dr David Johnson, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Virginia.

johnson-on-hcv-coffee

Unfortunately, chronic liver disease is not an uncommon process in this country. We do not have great management strategies for drug modification, particularly as it relates to nonalcoholic fatty liver disease (NAFLD), but there are a variety of these patients who might benefit from the addition of coffee.

A recent meta-analysis of 11 studies[1] looked at the effect of caffeine consumption in patients with chronic hepatitis C. This is a very interesting study that built on animal data, and one which I think is worthy of some discussion with your patients.

There are growing data on [caffeine use in] metabolic-related disease and NAFLD, and [results of this study were] impressive for hepatitis C. The [investigators] did an excellent job of extracting, scoring, and assessing the quality of the studies [comprising the meta-analysis]. Six studies [evaluated] liver enzymes, and five studies used [advanced] hepatic fibrosis as an endpoint. Three studies looked at hepatitis C viral load, and two studies looked at the effects on hepatocellular carcinoma.

All of these studies came back with the same message—that caffeinated brewed coffee reduces risk for these endpoints. Why might that be?

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Study: Modern Hepatitis C Drugs are Very Costly and Unavailable to Many State Prisoners

prisoners-hcv-treatmentLess than 1% of prisoners with hepatitis C in state correctional facilities in the United States are receiving treatment according to a new study in the October issue of Health Affairs conducted by the Association of State Correctional Administrators in collaboration with the Yale Global Health Justice Partnership. The study found that the main barriers to increasing access to care are the high price of the medications, the few policy options available for reducing drug costs for state correctional facilities and the lack of funding for state correctional health services to meet the needs of incarcerated patients.

Caught between costly hepatitis C medications and an enormous need for treatment, prison officials are forced to make difficult decisions about who to treat, explained A.T. Wall ’80, the Director of the Rhode Island Department of Corrections and a co-author of the study. “Patients and prison officials alike want to cure hepatitis C infections. That requires financial resources and discounts we don’t have. What we desperately need are less costly drugs and more funding.”

Hepatitis C, a liver disease that can lead to severe illness and death, affects 3 million adults in the United States, according to the Center for Disease Control and Prevention (CDC). About one-third of those people spend at least part of the year in correctional facilities. Two new hepatitis C medications, Sovaldi (sofosbuvir) and Harvoni (sofosvubir/ledipasvir), cure the vast majority of patients. However, they are extremely expensive, with list prices of $84,000 and $94,500 for a 12-week course of treatment of each drug respectively.

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FDA Adds Boxed Warning to Hepatitis C Drugs, Warns of Hepatitis B Reactivation Risk

istock_000004180692largeThe US Food and Drug Administration (FDA) on Tuesday warned of serious risks for some patients who have been infected with the hepatitis B virus (HBV) and are being treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus (HCV).

FDA identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs between 22 November 2013 and 18 July 2016.

Of the cases reported, two patients died and one required a liver transplant, though FDA cautions that this number includes only cases submitted to FDA, so there are likely additional cases.

As a result, FDA is now requiring a boxed warning to be added to nine DAAs, including Gilead’s blockbusters Harvoni and Sovaldi, as well as Abbvie’s Viekra Pak and Bristol-Myers Squibb’s Daklinza.

– See more at: http://www.raps.org/Regulatory-Focus/News/2016/10/04/25946/FDA-Adds-Boxed-Warning-to-Hepatitis-C-Drugs-Warns-of-Hepatitis-B-Reactivation-Risk/#sthash.upHoT1bH.dpuf