Notes from the Field: Hepatitis C Outbreak in a Dialysis Clinic — Tennessee, 2014 Weekly – January 1, 2016 Outbreaks of hepatitis C virus (HCV) infections can occur among hemodialysis patients when recommended infection control practices are not followed (1). On January 30, 2014, a dialysis clinic in Tennessee identified acute HCV in a patient (patient A) during routine screening and reported it to the Tennessee Department of Health. Patient A had enrolled in the dialysis clinic in March 2010 and had annually tested negative for HCV (including a last HCV test on December 19, 2012), until testing positive for HCV antibodies (anti-HCV) on December 18, 2013 (confirmed by a positive HCV nucleic acid amplification test). Patient A reported no behavioral risk factors, but did have multiple health care exposures.
On April 16, 2014, the Tennessee Department of Health observed infection control practices at the clinic. Clinic officials reported that no changes to infection control protocols at the dialysis clinic had been made from the time patient A was identified to this date of observation. The health department observers noted that no visible blood was present on any surfaces, sinks were easily accessible, staff hand hygiene was performed consistently, and gloves and other personal protective equipment were used appropriately. Individual patient stations were disinfected after the previous patient left the station, with a 1:100 diluted household bleach solution, and surfaces were allowed to dry completely between patients. Medications were prepared for each patient in a separate, clean medication room at the time of administration; no multidose medication vials were carried into patient care areas. Blood for glucose testing was drawn from dialysis access sites with a syringe and tested by a glucometer in the laboratory. The glucometer was adequately disinfected between uses. Monthly trainings in infection control had been consistently provided to all staff members before the outbreak was identified.
Sixty-two dialysis patients were being treated at the clinic at the time of the investigation; all were retested for HCV. Nine (15%) patients, including patient A, were HCV-infected; specimens from patient A and five other chronically infected dialysis patients were positive for HCV genotype 1a (Figure), the remaining three were positive for genotype 1b. Genotype 1a is the most prevalent genotype in the United States (2). Patient B, who seroconverted in December 2010, had a history of injection drug use, which, at the time of diagnosis, was considered to be the source of exposure. Patient C was chronically infected and had tested positive for HCV upon admission at the dialysis clinic. Infection duration for all other HCV infected patients, including patient C, was unknown. Quasispecies (HCV intra-genotype variants) analysis was performed from serum specimens collected from all nine patients found to be HCV positive. Patients A, B, and C were infected with genotype 1a; less than 5% nucleotide variation among intra-host HCV sequences was detected among the three patients, suggesting epidemiologic linkage of these infections (Figure). On separate occasions, patients A and B underwent dialysis on the same machine following patient C, during the most likely exposure periods (January–May 2013 for patient A and November 2009–June 2010 for patient B). Hospitalization events for patients A, B, and C during the likely exposure periods did not overlap in space and time. No other common exposures were identified.
Note: This is the European country of Georgia – Alan
The year 2015 began with wonderful success story of Estonian-Georgian co-production film Tangerines (Mandarinebi), which has been selected as one of five films in the Best Foreign Language Film category at the Oscars 2015.
The war-time drama, directed by Georgian man Zaza Urushadze, was chosen as one of five finalists from a larger pool of eighty-three nominated films in the Best Foreign Language Film category.
Monroe County has become the fourth in the state to receive approval from the Indiana State Department of Health to start a needle exchange program.
Higher-than-normal rates of hepatitis C led the Monroe County Health Department to ask the state to OK a clean syringe program as one way to combat the problem.
In a request sent to the Health Department in August, Monroe County Health Commissioner Thomas Sharp said that hepatitis C cases in his county have risen by more than 50 percent in the past five years. A little less than 70 percent of new cases of hepatitis C seen at IU Health Bloomington Hospital are attributed to IV drug use, he wrote.
A decade ago, about 34,000 New Mexicans had hepatitis C, but fewer than 1,600 were receiving treatment. Why so few?
Two-thirds of New Mexicans live in rural areas but two-thirds of the state’s physicians are in urban areas, so taking advantage of new treatments required patients driving hundreds of miles for up to 18 sessions of treatment. That was impractical, and put treatment out of reach for most.
Enter Project ECHO (Extension for Community Healthcare Outcomes).
A new report on the high price of a breakthrough hepatitis C drug affirms what state health care officials have known for some time: That the regimen’s $84,000 price tag limited the number of patients who could access it, while straining the budgets of state Medicaid programs that had to pay for it.
What state officials don’t expect to see is relief from high drug prices in the near future.
According to a U.S. Senate report released this month, when Gilead Sciences introduced its innovative hepatitis C treatment, Sovaldi, two years ago, the company knowingly priced it above what many people could afford to pay.
The Turnbull government will spend more than $1 billion to make breakthrough hepatitis C cures available to all as part of an ambitious new plan to eradicate the deadly disease within a generation.
Health Minister Sussan Ley will announce the major new Pharmaceutical Benefits Scheme listing on Sunday, in a move that will give Australia’s 230,000 hepatitis C sufferers affordable access to the drugs.
The drugs can currently cost patients up to $100,000. Under the subsidy, they will be available for the normal PBS co-payment of $37.70 for general patients and $6.10 for concessional patients.
TORONTO, Dec. 17, 2015 – More than one in nine people with hepatitis C in Canada spend time in a correctional facility each year and researchers said this presents a unique opportunity to focus hepatitis C prevention and control efforts in incarcerated populations.
People who have spent time in correctional facilities have higher risk factors for hepatitis C, including injection drug use and needle sharing, both in custody and in the community, according to the paper published online today in the Canadian Journal of Public Health.
“Incarcerated individuals are more likely to be infected with hepatitis C and more likely to continue the transmission cycle because of their involvement in risky behaviours such as sharing needles,” said Dr. Fiona Kouyoumdjian, a post-doctoral fellow with the Centre for Research on Inner City Health of St. Michael’s Hospital. “Time in custody is a unique opportunity for health-care workers to offer prevention activities to people who may otherwise be difficult to reach.”
The U.S. Food and Drug Administration (or FDA) has scheduled the Prescription Drug User Fee Act (or PDUFA) date for Merck’s (MRK) hepatitis C (or HCV) combination therapy, grazoprevir/elbasvir (100mg/50mg), for January 28, 2016. The therapy is being tested for HCV patients belonging to genotype one, four, and six including difficult-to-treat patients such as those who have failed to respond to previous therapy, those with liver cirrhosis, those suffering from HIV and HCV co-infection, and those with chronic kidney diseases. The PDUFA date is a deadline by which the FDA announces its decision for new drugs.
The FDA may announce its decision before this date. However, the majority of new drugs are approved or rejected on the scheduled PDUFA date. The FDA’s decision is important for Merck investors, as it determines the future profitability of the company.
HCV market opportunity The above diagram shows that there are about 4 million people suffering from HCV in the US, of which 79% suffer from genotype 1 HCV. Additionally, 2.6 million people in the big five countries in Europe and 1.1 million people in Japan suffer from HCV. The prevalence of the disease is substantially higher in emerging economies with 70.8 million HCV patients in Asia, 5.4 million patients in Latin America, and 6.7 million patients in other European countries. This underlines the scale of opportunity available for HCV players such as Merck (MRK), Gilead Sciences (GILD), AbbVie (ABBV), and Bristol-Myers Squibb (BMY).