Behind The Headlines - New hepatitis C drug treatment 'shows promise'

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New hepatitis C drug treatment 'shows promise'
"A new treatment for hepatitis C 'cured' 90% of patients with the infection in 12 weeks, scientists said," BBC News reports after a new drug protocol designed to target the protein that assists the spread of the virus through the body has shown promising results.

The study the BBC reports on involved 394 people with hepatitis C who had not responded to previous standard treatment, or who had responded but later relapsed.

They were randomised to either an active five-drug combination or a matching placebo for 12 weeks. The five drugs were ABT-450, ritonavir and ombitasvir, dasabuvir and ribavirin. At the end of the 12-week treatment period, the active treatment group stopped treatment, while all people in the placebo group switched to receiving 12 weeks' active treatment.

The people in the original active treatment group were only assessed 12 weeks after they had stopped taking their treatment, at which time the majority of them (96%) did demonstrate a response.

However, because of their unusual RCT design, by this time there was no comparison group as the placebo group had just then completed the same 12-week course of treatment. In this sense, the research was essentially a cohort study that has reported the outcomes for a group of people tested with a particular treatment.

Overall, the results suggest that this drug combination may be effective for people with the hepatitis C virus who have not responded to previous treatment. But whether this is more effective or more tolerable than other standard treatment options for such people remains to be proven. Side effects remain a big issue in terms of drug treatments for hepatitis C.

Where did the story come from?

The study was carried out by researchers from Johann Wolfgang Goethe University and Hannover Medical School in Germany and other institutions in Europe, the US, Canada and Australia. It was funded by the pharmaceutical company, AbbVie.

It is unclear whether there were any conflicts of interest, as relevant information was not provided in the study.

The study was published in the peer-reviewed medical journal, the New England Journal of Medicine, on an open access basis, so the study is free to read online.

BBC News is perhaps a little premature in hailing this treatment a breakthrough considering the limitations of the study's design. A randomised controlled trial comparing this combination with standard treatment is needed first. There were also some inaccuracies in the BBC's reporting, as the participants in the study did not have liver cirrhosis, as reported.

What kind of research was this?


This was a randomised controlled trial that aimed to examine the effectiveness and safety of a combination of drugs compared with inactive placebo in people with hepatitis C infection. It is reported to be a phase 3 randomised controlled trial, though arguably the study design does not meet the standards of a phase 3 RCT as there is no comparison with another treatment.

The study involved patients who had previously been treated with the standard treatment option for hepatitis C (specifically, genotype hepatitis C 1, which is the most common type of the virus), but who had not got better with this treatment.

This treatment is the combination of pegylated interferon and ribavirin, which is licensed for the treatment of hepatitis C. Previous research has shown that up to 50% of people with hepatitis C respond to this combination (as demonstrated by the virus being no longer detected in the blood).

An additional two drugs (telaprevir and boceprevir) have also been recommended as treatment options for use in combination with peginterferon–ribavirin in people who have the type 1 hepatitis C virus. Response rates have been shown to increase to up to around three-quarters in people who receive first-line treatment with one of these triple therapy combinations.

However, response rates to triple therapy can be lower in people who have previously been treated with peginterferon–ribavirin. There are many reports of patients not responding, or responding but later relapsing.

The peginterferon–ribavirin combination and the newer drugs telaprevir and boceprevir are also associated with side effects such as anaemia. There is therefore still a need for new, more effective and better-tolerated drug treatments to be developed.

This phase 3 randomised controlled trial investigated the use of non-interferon-based combination treatment with the drugs ABT-450, ritonavir and ombitasvir (in one formulation), dasabuvir and ribavirin. This combination was compared with matching placebo for 12 weeks.

Earlier phase studies demonstrated that the majority of people with type 1 hepatitis C infection who had previously not responded to peginterferon–ribavirin did respond to this five-drug combination.

This trial therefore aimed to further investigate the safety and effectiveness of this treatment combination in people with genotype 1 hepatitis C who had previously not got better with peginterferon–ribavirin.

These drugs can also all be taken by mouth, while peginterferon has to be given by injection under the skin.

What did the research involve?

The researchers included adults with genotype 1 hepatitis C (virus RNA level more than 10,000 international units per millilitre) who did not have liver cirrhosis.

The participants had also not responded to previous dual combination treatment with peginterferon–ribavirin.

Non-response to previous treatment included those with:
initial response and later relapse (undetectable viral RNA at treatment end but detectable levels within one year)
partial response (viral RNA levels decrease by a certain amount at week 12 of treatment, but detectable again by treatment end)
no response

The researchers did not include people who had previously not responded to triple therapy, or who had HIV infection or a recent history of drug or alcohol abuse.

People were recruited across 76 sites in North America, Europe and Australia. They were randomised to receive either inactive placebos or the active drug combination for 12 weeks, which included:
the co-formulation of ABT-450/r–ombitasvir (a once-daily dose of 150mg of ABT-450, 100mg ritonavir, and 25mg of ombitasvir)
dasabuvir (250mg twice daily)
ribavirin (1000mg daily if body weight was less than 75kg or 1200mg daily if body weight was equal to or greater than 75kg

People in the placebo group received matching placebo pills for these three sets of tablets. The study was double blind, meaning that neither participants nor researchers knew which treatment was being given.

The main outcome examined was the rate of a sustained virologic response (SVR) 12 weeks after the end of the study treatment. This is a term used to describe when the person has undetectable levels of the viral RNA in their blood. SVR for hepatitis C is defined as having an RNA level of less than 25 international units per millilitre.

Other outcomes examined included normalisation of liver enzyme levels, treatment response according to whether the genotype was 1a or 1b, and relapse after treatment.

Side effects of treatment were monitored throughout treatment and up to 30 days after the last drug dose.

All analyses were by intention to treat on the basis that all people who received at least one dose of the study drug were included in the analyses, regardless of whether they completed treatment.

Of note, the research describes that after the 12-week double-blind treatment period, people in the placebo group received the active treatment regimen on an open-label basis for 12 weeks.

As the outcomes were assessed 12 weeks after treatment end, this suggests that at the time of assessment people assigned to the placebo group had been receiving the active treatment for the past 12 weeks, while those assigned to the active treatment had completed 12 weeks of active treatment 12 weeks ago. A case could therefore be made that this was more of a cohort study than a textbook RCT.

What were the basic results?

Of 562 eligible people, 395 were randomised and 394 received at least one dose of their assigned treatment and were included in the analyses.

Twelve weeks after treatment was completed, 286 of 297 people in the active treatment group (96.3%) had a sustained virologic response. Looking by specific genotype, there was little difference in SVR rates between those with hepatitis C virus type 1a (96%) and 1b (96.7%).

According to previous response to peginterferon–ribavirin, SVR rates were 95.3% among those with initial response then relapse, 100% among those with previous partial response, and 95.2% among those with previous null response. Only 7 of 293 people (2.4%) who completed treatment had a post-treatment relapse.

SVR rates for those receiving placebo are not reported. However, at the time of outcome assessment, people in the placebo group had been receiving the active treatment for the past 12 weeks.

During the 12-week double-blind treatment period, side effects were reported by 91% of the active treatment group and 83% of the placebo group. Headache was the most common side effect in both groups, occurring in just over a third of people. Itching occurred significantly more often in the active treatment group (13.8% versus 5.2% in people taking placebo).

Three people in the active regimen group (1.0%) discontinued the study drugs because of side effects. Anaemia also occurred significantly more commonly in the active treatment group, with a decrease in haemoglobin below 10g per decilitre affecting about 5%.

How did the researchers interpret the results?

The researchers concluded that, "Rates of response to a 12-week interferon-free combination regimen were more than 95% among previously treated patients with HCV genotype 1 infection, including patients with a prior null response."

Conclusion

Although designed as an RCT, the study had an analysis of drug effectiveness that becomes more like a single cohort of people receiving an active treatment, with no comparison arm.

People were assigned to the five-drug combination or matching placebos for 12 weeks. During this time, the side effects in both treatment groups were monitored and these could be compared, with itching and anaemia occurring more commonly in the active treatment group.

However, the double-blind drug treatment period was completed at 12 weeks and response outcomes were then assessed 12 weeks later. Twelve weeks later, the active treatment group demonstrated high response rates, with sustained virological response present in almost all (96%) of those who had been treated.

Problematically, however, there is no comparison group for these people. At the end of the 12-week double-blind treatment period, all people in the placebo group went on to receive 12 weeks' active treatment with the five-drug combination.

This means that at the time the outcomes were assessed in the active treatment group, the placebo group had also just completed 12 weeks of active treatment. The response rates for the placebo group are not reported.

Overall, the results suggest that the oral combination of ABT-450, ritonavir and ombitasvir (in one formulation) and dasabuvir and ribavirin may have potential in the treatment of hepatitis C.

However, the safety and effectiveness of this combination now need to be compared with other standard treatment options for this group of people – including repeat treatment with the peginterferon–ribavirin combination, and triple therapy with peginterferon–ribavirin and either telaprevir and boceprevir.

Only then will we know whether this five-drug combination may one day be licensed for this condition, and for which specific groups of people.

Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on Twitter. Join the Healthy Evidence forum.

Links to the headlines
Hepatitis C: New drug treatment 'is a breakthrough'. BBC News, April 12 2014
Links to the science

Zeuzem S, Jacobson IM, Baykal T, et al. Retreatment of HCV with ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin. The New England Journal of Medicine. Published online April 10 2014

Source - Behind The Headlines

Boomers' Dark Secret: Booze

Boomers' Dark Secret: Booze

What their caregivers don’t know or don't ask could end up hurting aging patients

Released: 4/18/2014 7:00 AM EDT
Source Newsroom: Johns Hopkins University School of Nursing

Newswise — A 70-year-old man suffers a heart attack and is brought into the Emergency Department. On aspirin therapy for a year, he had stopped it three weeks earlier on his physician’s advice after reporting more cardiac discomfort and using more nitroglycerin just to get through the day.

He needs bypass surgery, a fairly common and relatively quick procedure. Once surgery begins, though, so does uncontrolled bleeding. Thirteen hours later, the patient’s life has been saved, but he faces a complicated recovery.

Blame a potentially deadly and all-too-common cocktail, says Christine L. Savage, PhD, RN, CARN, professor and chair of the Department of Community-Public Health at the Johns Hopkins School of Nursing (JHSON). Alcohol is an anticoagulant. The patient, a lifelong drinker, was still drinking daily. The doctor didn’t know about it because he didn’t ask. In addition, the patient had heard only “aspirin,” not “children’s aspirin,” so he had been taking a higher-than-prescribed dosage of that blood thinner. (Nitroglycerin also opens blood vessels to improve flow.)

Simple Questions, Hard Answers

By 2015, all baby boomers will be 50 or older. In an editorial for the Journal of Addictions Nursing, Savage writes that, unlike members of previous generations, many of these individuals have been using alcohol (and other drugs) for their entire adult lives. There are consequences.

“Alcohol is a dirty drug, and it causes all kinds of long-term problems,” Savage says. Quoting a 2013 National Institute on Alcohol Abuse and Alcoholism report, she says alcohol contributes to increased risk for more than 65 diseases and conditions, including pancreatic, breast, and ear, nose, and throat cancers, liver disease, injuries, and cognitive impairment.

“It’s an equal opportunity problem that cuts across socioeconomic and gender lines,” adds Deborah Finnell, DNS, PMHNP-BC, CARN-AP, associate professor in the Department of Acute and Chronic Care at JHSON. “When people come in ... the best practice is to ask questions related to alcohol, tobacco, and other drug use. There are reliable and valid measures—very simple measures—that can be used” to screen for these issues. Unfortunately, she says, “those are not being widely implemented.”

Savage says, “We tend not to think about the older patient in front of us as somebody whose alcohol use may be putting them at risk, and we’re uncomfortable asking the cute grandmother or the stately older man about their alcohol use.”

Nancy Hodgson, PhD, RN, assistant professor in the JHSON Department of Acute and Chronic Care, emphasizes the importance of making the effort. That older patient could be experiencing “bereavement, isolation, loneliness, an underlying depression or pain, so they’re self-medicating as a numbing agent, using alcohol.”

The system incentivizes an acute-care approach when what is needed takes more time, says Laura N. Gitlin, PhD, professor and director of the Center for Innovative Care in Aging at JHSON. “Insurers, what are they paying for? They’re paying for a six-minute visit. They’re paying for tests. These aren’t tests. They are ways of talking to people and coming up with strategies that don’t require a chest X-ray or an MRI.”

One useful approach to screening and intervention is SBIRT (for Screening, Brief Intervention, and Referral to Treatment), which identifies patients with risky substance use, engages them in a brief conversation about that behavior, and refers those who need it to further treatment.

Finnell says this kind of screening should be standard practice, just like taking a patient’s blood pressure, pulse, and weight. She describes the brief intervention as a five- to 10-minute conversation that starts with “asking for permission to talk about it. Because of how society views alcohol and other drug use, it’s important to put people at ease.”

Hodgson says the nurse is the perfect person to start this conversation. “They have the rapport with the patients, they have the key assessment skills necessary to pick up the subtle changes — things like fall history, or unexplained lethargy or confusion — and dig deeper.”

“Older adults are probably more likely to talk to the nurse about more sensitive issues than they would perhaps the physician,” Hodgson adds.

Leading the Way

Ultimately, Finnell says, the goal is for nurses to be able to identify every patient with risky substance use and to raise awareness. Patients “may say, ‘I’m going to continue to drink at the same level I’ve been drinking.’ But if I can get them, at least, to begin to think about that, then I see that as a real success.” And if they agree they should decrease their alcohol use, she says, “then that’s a greater success.”

Savage and Finnell are part of a team working on a Substance Abuse and Mental Health Services Administration-funded training grant to integrate more content about alcohol and drugs into the graduate curricula to prepare nurses to meet this challenge. (For a current study, Finnell has developed a 20-minute video illustrating how alcohol affects the brain. She hopes to use it with patients in primary care who are identified with at-risk alcohol use.)

“We want for nurses who graduate from the Johns Hopkins School of Nursing to be leaders in the nation for moving this set of clinical strategies … across all healthcare settings, all populations, all settings,” Finnell says, adding that working nurses also need this education.

“We have over 3 million nurses in the nation,” Finnell says. “If those 3 million nurses had all been appropriately educated, then we could make a huge impact in terms of the global harm associated with alcohol use.”


Photo Credit - James Steinberg / james-steinberg.com

Previous Exposure to HCV Among Persons Born During 1945–1965

Previous Exposure to HCV Among Persons Born During 1945–1965

Prevalence and Predictors, United States, 1999-2008

Bryce D. Smith, PhD, Geoff A. Beckett, PA-C, MPH, Anthony Yartel, MPH, Deborah Holtzman, PhD, Nita Patel, DrPH, John W. Ward, MD
Am J Public Health. 2014;104(3):474-481.

Abstract and Introduction
Abstract

Objectives. We examined HCV exposure prevalence and predictors among persons in the United States born during 1945–1965.

Methods. With data from the 1999–2008 National Health and Nutrition Examination Survey, we calculated the proportion of persons born during 1945–1965 who tested positive for HCV antibody (anti-HCV) and analyzed the prevalence by sociodemographic and behavioral risk factors.

Results. Anti-HCV prevalence in the 1945–1965 birth cohort was 3.2% (95% confidence interval [CI] = 2.8%, 3.8%), substantially higher than among other adults (0.9%). Within the cohort, anti-HCV prevalence was higher among non-Hispanic Blacks (6.4%; 95% CI = 5.3%, 7.7%), persons with injection drug use histories (56.8%; 95% CI = 48.4%, 64.8%), and persons with elevated alanine aminotransferase levels (12.7%; 95% CI = 10.7%, 15.1%). Injection drug use (adjusted odds ratio = 98.4; 95% CI = 58.8, 164.5) was the strongest anti-HCV prevalence predictor. Among anti-HCV–positive persons, 57.8% reported having 2 or more alcoholic drinks daily.

Conclusions. With the high prevalence of HCV among persons born during 1945–1965, the increasing morbidity and mortality associated with HCV, and reductions in liver cancer and HCV-related mortality when HCV is eradicated, it is critically important to identify persons with HCV and link them to appropriate care.
Introduction

In the United States, the incidence of HCV infection rose dramatically through the 1970s and 1980s reaching more than 200 000 new infections per year through the mid- to late-1980s.[1] This high incidence resulted in a disproportionately high burden of HCV infection among Americans who were born between the mid-1940s and the mid-1960s, a birth cohort popularly referred to as the baby boom generation.[2] Alter et al. first documented the relatively high prevalence of HCV infection among this cohort in their analysis of1988–1994 National Health and Nutrition Examination Survey (NHANES) data, reporting that 65% of persons with HCV infection were aged 30 to 49 years during the survey period.[3] In an analysis of NHANES data from 1999 to 2002, a similarly high proportion of all persons with HCV antibody had been born from 1945 through 1964.[1] This cohort effect on the high prevalence of HCV infection in the baby boom generation has been attributed largely to exposures (principally injection drug use [IDU] and blood transfusion before 1992) that occurred many years before the survey periods.[1,3] However, a significant proportion of HCV-infected persons do not report any risk factors,[4–6] perhaps because of fear of being stigmatized,[7] or simply lack of recall or knowledge of exposures such as those that may occur in health care settings.[8,9]

A validated Markov model forecasting lifetime morbidity and mortality attributable to HCV infection projected that of 2.9 million persons with untreated HCV infection who did not have cirrhosis of the liver in 2005, 1 071 000 (36.8%) will die from complications of HCV.[10] In the United States, HCV-associated disease is the leading indication for liver transplantation and HCV infection is a leading cause of hepatocellular carcinoma.[11–14] Approximately 73.9% of HCV-associated mortality occurs among persons born from1945 to 1965.[15]

In 1998, the Centers for Disease Control and Prevention recommended[16] that persons with certain risk factors (e.g., any history of IDU) or medical conditions (e.g., persistently elevated alanine aminotransferase [ALT] levels) be tested for HCV infection. Despite these recommendations, testing practices over the past decade have had limited success in identification of HCV infection in the United States as estimates of the proportion of persons who are unaware of their infection range from 40% to 85%.[17–20] Contributing to the limited success of the recommendations is the difficulty in obtaining risk behavior history that occurred in the distant past, the primarily asymptomatic nature of the infection, and a less than optimal level of physician knowledge regarding the natural history and prevalence of infection, the current recommendations for testing, and interpretation of test results.[21–24]

In 2011, the prospects for successful medical treatment of HCV infection were significantly improved with the US Food and Drug Administration licensure of 2 direct-acting antiviral medications, both in the protease inhibitor class. In clinical trials, the rates of sustained viral response—equivalent to a "virological cure"—increased from 44% with use of the current standard regimen, to 75% when a direct-acting antiviral medication was added to that regimen in treatment of persons infected with HCV genotype 1, the genotype that is most common in the United States.[25] Since this article was accepted for publication, the US Food and Drug Administration has approved new HCV medications[26,27] that have further increased cure rates to as high as 90% in clinical trials.

Persons who achieve a sustained viral response after treatment experience significantly less liver-related morbidity (including hepatocellular carcinoma),[28] less liver-related mortality,[29] and reductions in all-cause mortality.[30] However, the potential population benefits from these improvements in treatment effectiveness will be limited unless there are concurrent increases in the rate of identification and treatment of HCV-infected persons.[31]

Because of the limited effectiveness of risk based testing strategies to date and the high prevalence of HCV infection and projected disease burden, the Centers for Disease Control and Prevention recently issued the Recommendations for the Identification and Initial Care of Chronic Hepatitis C Virus Infection Among Persons Born During 1945–1965[32] with the goal of identifying persons with HCV infection who are undiagnosed. The recommendation was subsequently made by the US Preventive Services Task Force.[33] The purpose of the current study was to determine the proportion of persons in the birth cohort who were positive for antibody to HCV (anti-HCV), and to examine the sociodemographic and behavioral risk factors associated with anti-HCV prevalence.

Methods
We analyzed NHANES data collected from 1999 to 2008. NHANES is an annual nationally representative multistage, stratified probability cluster survey of the US civilian, noninstitutionalized population. Information on the survey design and implementation, including institutional review board approval and consent, is detailed in the survey documentation.[34,35]
Anti-HCV testing is administered to NHANES participants aged 6 years or older. We restricted our analysis to adult participants born from 1945 to 1965 who were interviewed and provided serum samples for anti-HCV testing. Birth year was estimated by subtracting participant age at time of survey from estimated year in which participant was surveyed. Because NHANES does not release data on participant birth year or the actual year in which a participant was interviewed or examined, we estimated the earliest survey year for each participant according to the variable, "six month time period when the examination was performed: November 1 through April 30, May 1 through October 31." As an example, for the 1999–2000 survey cycle, participants examined from November 1 to April 30 were assigned an earliest survey year of 1999 and those examined from May 1 through October 30 were assigned to the 2000 survey year. We excluded participants without specimens for testing and those with indeterminate anti-HCV results from the final analytic sample.

Outcome Variable
The outcome measure was anti-HCV prevalence as determined by serologic testing. We chose anti-HCV status as an endpoint because HCV RNA testing was not performed for the 2003–2004 NHANES cycle, and we determined that combining data from all 10 years (1999–2008) was necessary to achieve sufficient subdomain sample sizes for improved precision and reliability of point estimates.

Specimens were tested for antibodies to HCV by repeated enzyme-linked immunosorbent assay (ELISA version 3.0, Ortho Diagnostic Systems Inc, Raritan, NJ). Reactive specimens were confirmed by recombinant immunoblot assay (RIBA version 3.0, Chiron Corporation, Emeryville, CA). Participants who tested positive by both ELISA and RIBA were categorized as anti-HCV–positive.

Independent Variables
We examined the following independent variables as potential predictors or confounders of anti-HCV prevalence within the birth cohort: race/ethnicity, gender, country of birth, veteran status, marital status, educational attainment, family income, health insurance status, daily alcohol consumption within the past 12 months, age at first sexual intercourse, number of lifetime sexual partners, lifetime IDU (cocaine, heroin, and methamphetamine), history of blood transfusion before 1992, and ALT level.[1,3] We categorized race/ethnicity as non-Hispanic White, non-Hispanic Black, Mexican American, and other. We categorized educational attainment as completed less than high school and completed high school or more; marital status as married or living with partner, divorced or separated or widowed, and never married; and family income as greater than 2 times federal poverty threshold, 1 to 2 times federal poverty threshold, and less than the federal poverty threshold. We defined elevated ALT as 40 or more international units per liter. For independent variables with 10% or more of observations with missing values, we created an "unknown" category to include those missing values as valid for analysis. Accordingly, we categorized alcohol consumption as 0 or 1, 2 or more, and unknown number of drinks per day within the past year; age at first sexual intercourse as 17 years or younger, 18 years or older, and unknown; number of lifetime sexual partners as 0 to 9, 10 to 19, 20 or more, and unknown; lifetime drug use as never, non–injection drug use, IDU, and unknown.
NHANES questions related to sexual behavior and history of IDU are restricted to adult participants younger than 60 years. Thus, all analyses involving these variables in the current study were similarly restricted.

Statistical Analysis
We generated proportions and 95% confidence intervals (CIs) to describe the characteristics of the 1945–1965 birth cohort. We also produced estimates of anti-HCV prevalence in the birth cohort and by subgroups. We specified linear contrasts of estimates to test for statistical differences in characteristics between anti-HCV–positive participants and all participants, and to test for differences in anti-HCV prevalence between subgroups. We assessed statistical reliability of estimated proportions by evaluating relative standard errors (< 30%) and by ensuring that subdomains met NHANES minimum sample size requirements. We generated unadjusted odds ratios from univariate logistic regression models. We defined statistical significance as P value less than .05.

We developed a multivariate logistic regression model to identify independent risk factors associated with anti-HCV positivity within the birth cohort after we controlled for covariates. We specified an estimated full model by including all independent variables with a P value of less than .1 from the univariate analyses. Using a backward elimination procedure, we removed variables with the lowest observed partial F-statistic at a predetermined P value of less than .1. We simultaneously tested for 2-way interaction effects between race and IDU or gender and IDU, by using multiple partial F-tests. We assessed multicollinearity among covariates by review of diagnostic statistics including variance inflation factors (> 2.5), condition indices (> 15), and variance proportions (> 0.5; SAS version 9.3, SAS Institute, Cary, NC). In deciding whether to exclude a covariate because of collinearity, we also considered the relative importance of the covariate, its relationship with key variables such as IDU, and its contribution to the overall model fit.

We used the Hosmer–Lemeshow goodness-of-fit test to evaluate the overall fit of the final model. Except as otherwise specified, we analyzed all data with SAS-callable SUDAAN to account for the complex survey design (version 10.0.1, Research Triangle Institute, Research Triangle Park, NC). We rescaled sample weights after combining data across multiple survey years. We estimated variance and standard errors by using the Taylor series (linearization) method

Results
We identified a total of 8167 participants estimated to be born from 1945 to 1965 who were both interviewed and examined. After we excluded participants without specimens (n = 411) and those with indeterminate anti-HCV results (n = 33), the final analytic sample for the birth cohort was 7723 (95% of those examined). Table 1 shows the demographic, behavioral, and clinical characteristics of the birth cohort population and those in the cohort who were anti-HCV–positive. Relative to the total birth cohort population, a greater proportion of anti-HCV–positive participants were male, non-Hispanic Black, had a family income below the poverty threshold, and had no health insurance coverage. Among anti-HCV–positive participants, 41.9% reported a history of IDU, 16.2% received a blood transfusion before 1992, 57.8% consumed 2 or more alcoholic drinks per day, and 51.3% had elevated ALT levels. Combined, persons with a history of IDU or blood transfusion accounted for 51.7% of anti-HCV–positive participants; 48.3% reported no known exposure risks.

Prevalence of Anti-HCV in the Birth Cohort
Prevalence estimates for the birth cohort and subgroups are presented in Table 2. The overall prevalence of anti-HCV in the birth cohort was estimated at 3.2% (95% CI = 2.8%, 3.8%) or approximately 2.8 million (2.4 million to 3.2 million) persons with anti-HCV. Anti-HCV prevalence was higher among men (4.3%; 95% CI = 3.6%, 5.2%), non-Hispanic Blacks (6.4%; 95% CI = 5.3%, 7.7%), and persons with a family income below the poverty threshold (7.8%; 95% CI = 6.3%, 10.0%), respectively, compared with women, non-Hispanic Whites, and persons with a family income of more than 2 times the poverty threshold.

Table 2.  Characteristics and Risk Factors Associated With HCV Antibody Prevalence Among Adults Born From 1945 to 1965: National Health and Nutrition Examination Survey, 1999–2008
CharacteristicParticipants Tested, No.Prevalence of Anti-HCVUnadjusted Odds Ratios
% (95% CI)P a Unadjusted OR (95% CI)P
Overall77233.2 (2.8, 3.8)
Gender
   Female (Ref)39112.2 (1.7, 2.9)1.0
   Male38124.3 (3.6, 5.2)< .0012.0 (1.4, 2.8)< .001
Race/ethnicity
   Non-Hispanic White (Ref)36482.9 (2.3, 3.6)1.0
   Non-Hispanic Black17006.4 (5.3, 7.7)< .0012.3 (1.7, 3.0)< .001
   Mexican American15643.3 (2.4, 4.4).511.1 (0.8, 1.6).5
Marital status
   Married or living with partner (Ref)51702.7 (2.2, 3.4)1.0
   Divorced, separated, or widowed16404.3 (3.3, 5.5).241.6 (1.1, 2.3).02
   Never married7475.7 (4.0 8.0).0042.2 (1.4, 3.3)< .001
Country of birth
   United States58363.6 (3.1, 4.2)< .0013.3 (1.9, 5.6)< .001
   Other (Ref)18841.1 (0.7, 1.8)1.0
Education level
   £ high school38384.8 (4.0, 5.9)< .0012.3 (1.7, 3.1)< .001
   > high school (Ref)38792.2 (1.8, 2.7)1.0
Family income to poverty threshold
   > 2 times (Ref)44642.1 (1.7, 2.7)1.0
   1–2 times15245.6 (4.2, 7.5)< .0012.8 (1.9, 4.1)< .001
   Below11837.8 (6.3, 9.6)< .0013.9 (2.9, 5.3)< .001
Health insurance coverage
   Yes (Ref)59192.7 (2.3, 3.1)1.0
   No17576.2 (4.8, 8.0)< .0012.4 (1.8, 3.3)< .001
Served in the US armed forces
   No (Ref)67653.0 (2.5, 3.5)1.0
   Yes9555.1 (3.7, 6.9).011.7 (1.2, 2.5).004
Average no. of alcoholic drinks/d, last y
   0–1 (Ref)24921.2 (0.8, 1.8)1.0
   ‡ 232724.3 (3.6, 5.3)< .0013.7 (2.3, 5.9)< .001
   Unknown19594.2 (3.3, 5.2)< .0013.6 (2.3, 5.6)< .001
Age at first sexual intercourse (up to 59b y; n = 7210), y
   £ 1732585.0 (4.3, 5.9)< .0013.7 (2.5, 5.5)< .001
   ‡ 18 (Ref)28711.4 (1.0, 2.1)1.0
   Unknown10813.5 (2.5, 5.0).0042.5 (1.5, 4.4)< .001
No. of lifetime sexual partners (up to 59b y; n = 7210)
   0–9 (Ref)45071.4 (1.0, 2.0)1.0
   10–199163.9 (2.6, 5.7).0012.9 (1.8, 4.6)< .001
   ‡ 2011339.9 (8.2, 11.9)< .0017.8 (5.2, 11.8)< .001
   Unknown6544.5 (3.1, 6.5).0013.3 (1.9, 5.7)< .001
Lifetime drug use (up to 59b y; n = 7210)
   Never (Ref)51011.2 (0.9, 1.6)1.0
   Non-IDU12803.7 (2.8, 4.8)< .0013.1 (2.1, 4.5)< .001
   IDU18756.8 (48.4, 64.8)< .001107.0 (69.3, 165.1)< .001
   Unknown6424.7 (3.3, 6.8)< .0014.0 (2.5, 6.6)< .001
Blood transfusion before 1992
   No (Ref)70302.9 (2.5, 3.5)1.0
   Yes5816.7 (4.8, 9.4).0022.4 (1.6, 3.5)< .001
Serum alanine aminotransferase level, U/L
   < 40 (Ref)65991.8 (1.5, 2.2)1.0
   ‡ 40105612.7 (10.7, 15.1)< .0018.0 (6.0, 10.5)< .001
Note. Anti-HCV = HCV antibody; CI = confidence interval; IDU = injection drug use; OR = odds ratio.

aObtained by specifying linear contrasts of proportions among the levels of the subgroups.


bNational Health and Nutrition Examination Survey data collection on certain risk factors was limited to participants aged 20–59 years at time of survey; accordingly the 2005–2006 and 2007–2008 National Health and Nutrition Examination Survey cycles do not contain data risk factor for participants born in 1945–1946 and 1945–1948, respectively.

Among participants reporting a history of IDU, 56.8% (95% CI = 48.4%, 64.8%) were anti-HCV–positive compared with 1.2% (95% CI = 0.9%, 1.6%) for those who had never used any illicit drugs. Persons who received a blood transfusion before 1992 had a higher prevalence of anti-HCV (6.7%; 95%CI = 4.8%, 9.4%) than did those without this history (2.9%; 95% CI = 2.5%, 3.5%). Among persons with elevated ALT levels, 12.7% (95% CI = 10.7%, 15.1%) were anti-HCV–positive relative to 1.8% (95% CI = 1.5%, 2.2%) for those with normal ALT levels.

Factors Associated With Anti-HCV Prevalence Within the Birth Cohort
Unadjusted odds ratios (ORs) and 95% CIs for characteristics associated with anti-HCV prevalence are displayed in Table 2. Men, non-Hispanic Blacks, and persons with a family income below the poverty threshold, respectively, were more likely to be anti-HCV–positive compared with women, non-Hispanic Whites, and persons with family income of more than 2 times the poverty level. Injection drug use was the strongest predictor of anti-HCV prevalence among the birth cohort. Other characteristics significantly associated with anti-HCV prevalence were elevated ALT level, consumption of 2 or more alcoholic drinks per day, sexual intercourse before age 18 years, 20 or more lifetime sexual partners, and blood transfusion before 1992.

After we controlled for covariates in a multivariate logistic regression model (Table 3), IDU (adjusted OR = 98.4; 95% CI = 58.8, 164.5) remained the strongest predictor of anti-HCV prevalence. We also identified the following variables as significant risk factors for anti-HCV prevalence in the multivariate model: elevated ALT level (9.0; 95% CI = 6.0, 13.7), a family income below the poverty threshold (4.7; 95% CI = 3.0, 7.4), US-born (3.2; 95% CI = 1.7, 6.1), non-Hispanic Black race (2.3; 95% CI = 1.7, 3.2), and blood transfusion before 1992 (2.3; 95% CI = 1.3, 4.0). We removed number of sexual partners and age at first sexual intercourse from the multivariate model because of collinear relationships with IDU. No interaction terms were significant.

Discussion
These findings highlight the relatively high prevalence of anti-HCV (3.2%) among persons in the 1945–1965 birth cohort compared with the prevalence among adults aged 20 to 70 years during the 1999–2008 survey period, but born before 1945 or after 1965 (0.9%; unpublished Centers for Disease Control and Prevention data); persons in the birth cohort were 4 times more likely to be anti-HCV–positive than adults outside the cohort. Our finding that history of IDU, blood transfusion, elevated ALT, Black race, and poverty were associated with HCV infection within the birth cohort is consistent with previous findings based on the general US adult population.[1,3] However, IDU and blood transfusions before 1992, the most common exposure risks reported by persons infected with HCV, account for only 52% of infections and the remaining 48% report no known exposure risk and may not be identified through risk-based testing approaches. Testing for HCV infection on the basis of the birth cohort presents an opportunity to identify a significant proportion of cases that may otherwise go undetected in a subpopulation that accounts for approximately 75% of the burden of HCV infection in the adult US population.[5] The 1945–1965 birth cohort has the highest incidence of HCV-related liver disease and death, which is projected to increase sharply over the next 2 decades.[10,36,37]

Most persons in the birth cohort are likely to have been infected for 20 to 40 years or more, and multiple models have indicated that there will be dramatic increases in the numbers of HCV-infected persons with significant liver disease over the next 10 to 20 years[31,38] without effective public health interventions. Even with declining prevalence in the overall US population, HCV disease burden is expected to increase significantly because of the aging of the infected population.[10,36] Identification of HCV-infected persons and planning for care and therapy now, however, will improve efforts for long-term care and management of the infected population.[39] Although treatment response is better among persons younger than 40 years than those aged 40 years or older, persons older than 65 years have been shown to respond as well to therapy as those between the ages of 40 and 65 years, a fact that will become increasingly important as the birth cohort ages into retirement.[40]

For HCV-infected persons for whom antiviral treatment is indicated,[41] there have been recent medical advances that significantly improve the efficacy of therapy. Unfortunately, HCV treatment rates are low.[42] We found that almost one third of anti-HCV–positive persons in this cohort report being uninsured, a problem that certainly contributes to low treatment rates and difficulty accessing care. Expansion of coverage for medical care could increase access to care and treatment.
Even for those infected persons who do not receive antiviral medication, because of treatment contraindications or for other reasons, interventions are available that may limit disease progression and decrease HCV transmission to other persons. Reducing alcohol use can prevent exacerbation of liver disease. In our analysis, however, we found that nearly 58% of anti-HCV–positive persons in the birth cohort reported drinking 2 or more alcoholic drinks per day on average. Alcohol use is associated with development and progression of fibrosis and significant increase in liver-related and overallmortality.[41,43,44] Among HCV-infected persons, history of and current moderate alcohol use (approximately 2 drinks/day or less) have been found to be associated with a 2-fold increase in all-cause mortality and 7-fold increase for those who report drinking 2 or 3 drinks per day.[43] The prevalence of alcohol use among anti-HCV–positive birth cohort members suggests that use of Screening and Brief Interventions for Referral for Treatment of the Reduction of Alcohol Use as recommended by the US Preventive Services Task Force may be beneficial.[45] It has furthermore been suggested that, among heavy drinkers, knowledge of HCV-positive status and brief counseling received from health care providers upon diagnosis may be important factors in the reduction of alcohol use.[46,47]

Limitations
There are limitations in this study. First, NHANES samples include only the US civilian, noninstitutionalized population. A large number of high-risk persons who are incarcerated, institutionalized, or homeless are excluded; thus, these analyses are likely to result in an underestimate of anti-HCV prevalence. Second, behavioral risk-factor data were limited to participants aged 60 years or younger. As a consequence, for the 2005–2006 NHANES cycle, no risk-factor information was available for participants born during 1945–1946 (who would have been aged 60–61 years during the 2005–2006 cycle). Likewise, there were no risk factor data for participants born during 1945– 1948 in the 2007–2008 cycle. Third, nearly all risk-factor data used in this analysis were self-reported. Participants may overreport or underreport behaviors in response to questions such as IDU or number of lifetime sexual partners, which might bias our results. Fourth, participant birth year was approximated from estimated year of interview and age at survey.
Finally, we did not examine differences by sociodemographic and risk characteristics between persons who knew and those who did not know their HCV-infection status (positive or negative) before testing because prior knowledge of HCV-infection status is not assessed for NHANES participants. However, among participants who test positive for anti-HCV or those with an indeterminate test result for anti-HCV plus a positive HCV-RNA, NHANES conducts a separate follow-up survey to ascertain knowledge of HCV infection status before receiving notification of results from NHANES. Although analyses[31,48] of the follow-up survey data have suggested differences— by age, access to health care, knowledge of risk factors—between HCV-positive persons who were aware of their status versus those who were unaware, those findings are by themselves limited by small sample sizes, low survey response rates, and their lack of generalizability to all persons, HCV-positive or -negative.

Conclusions
This study provides additional evidence of the high prevalence of anti-HCV among persons in the 1945–1965 birth cohort consistent with earlier studies of infection prevalence. Considerable racial and socioeconomic disparities by anti-HCV positivity status also are apparent within the cohort. High rates of alcohol use reported by anti-HCV–positive respondents suggest the importance of diagnosing infection and providing effective interventions to decrease alcohol consumption and slow the progression of liver disease. In light of the high prevalence of HCV infection among persons born during 1945–1965, the increasing morbidity and mortality associated with HCV infection, and reductions in liver cancer and HCV-related mortality when HCV infection is eliminated, it is critically important to identify those persons living with hepatitis C and link them to appropriate care and treatment.

References

UnitedHealth: New hepatitis C drug costs far more than forecast

Recasts to focus on hepatitis C spending

By Caroline Humer

April 17 (Reuters) - UnitedHealth Group Inc, the largest U.S. health insurer, said on Thursday it has spent more than $100 million to cover a pricey new hepatitis C drug from Gilead Sciences Inc, a higher cost than it expected by "multiples," sending shares in the sector lower.

UnitedHealth is the first insurer to put a number to what the industry may pay to cover patients using Gilead's new Sovaldi treatment, whose $84,000 price tag has spurred a national outcry over the rising costs of specialty medicines. . UnitedHealth did not disclose what it had expected to spend on the hepatitis C drug.

UnitedHealth shares fell nearly 4 percent. Rivals WellPoint Inc and Aetna Inc fell 3.8 percent and 3.4 percent, respectively.

Daniel Schumacher, chief financial officer of the group's UnitedHealthcare division, said the spending on Sovaldi could begin to moderate after the first big wave of patients are treated with the drug.

Sovaldi is widely viewed as a breakthrough in treating the liver-wasting virus, since it has been shown to cure most patients after a 12-week course of therapy.

Many doctors had waited for drug, which was approved for use in the United States in December, before prescribing treatment for their patients.

"What we're seeing is consistent with what folks are seeing across the industry, which is higher pent-up demand as there were more patients that were warehoused leading up to the launch," Schumacher said.

UnitedHealth saw increased spending levels due to Sovaldi in its Medicaid, Medicare and commercial businesses during the first quarter of 2014, he said.

The disclosure came as UnitedHealth said its quarterly profit fell due to costs and taxes related to President Barack Obama's healthcare law as well as government cuts to private Medicare funding.

The company said the costs related to the Affordable Care Act and the effects of budget sequestration last year on payments from the government negatively affected earnings by about 35 cents per share. Its Optum technology-related division, which has worked on the online insurance exchanges created by that reform law, continued to grow.

The company's quarterly results slightly beat analyst expectations. UnitedHealth said net profit was $1.1 billion, or about $1.10 per share, compared with $1.2 billion, or $1.16 per share a year earlier. Analysts had expected first quarter profit of $1.09 per share, according to Thomson Reuters I/B/E/S.

UnitedHealth stuck by its previous forecast for 2014 earnings of $5.40 to $5.60 per share and said it sees revenue growth of about 5 percent to $128 billion to $129 billion.

Government healthcare has been a fast-growing business for these companies, and in particular private Medicare, called Medicare Advantage, for older people and the disabled.

UnitedHealth provides private Medicare, Medicaid, and military health plans as well as commercial healthcare plans such as employer-based insurance. It had 44.67 million medical members at the end of the quarter, down from 45.45 million at the end of 2013, due to declines in the commercial business.

Obama signed the Affordable Care Act into law in 2010 and many of its key elements went into effect on Jan. 1, 2014, including new insurance coverage for individuals subsidized based on income and the expansion of Medicaid to people with higher income levels than was previously available.

The Obamacare exchanges were riddled with technology issues that affected the roll-out and created new business for UnitedHealth's QSSI unit, which helped fix the federal enrollment website HealthCare.gov and was also hired by some states that run their own exchanges.

Optum, which also includes other health technology related businesses, had revenue of $11.2 billion, up from $8.7 billion in the year-earlier quarter. Earnings from operations rose to $650 million from $541 million. (Reporting by Caroline Humer; Editing by Michele Gershberg and Chizu Nomiyiama)

NHS England agrees funding for life-saving hepatitis C drug

England agrees funding for Gilead hepatitis C drug
LONDON, April 17 (Reuters)

Health authorities in England have approved an 18.7 million pound ($31 million) investment to provide Gilead Sciences' controversial new hepatitis C pill Sovaldi for seriously ill patients.

Healthcare provider NHS England said the decision would benefit about 500 patients suffering from acute liver failure, many of whom are awaiting a liver transplant.

The recommendation means that while Sovaldi has not yet been approved by the National Institute for Health and Clinical Excellence (NICE), the country's cost-effectiveness watchdog, it will be funded for those patients at significant risk of dying.

NICE is due to publish its guidance on whether Sovaldi is worth using widely on the state-run National Health Service later this year.

Sovaldi is far more effective and better-tolerated than older treatments, but its high cost has provoked criticism from healthcare campaigners and insurers.

The current U.S. price for a 12-week course of treatment with Sovaldi is $84,000, or $1,000 for each once-daily pill, but Gilead has said the price in Britain will be about $57,000. ($1 = 0.5955 British Pounds) (Reporting by Ben Hirschler; Editing by David Goodman) 


NHS England agrees funding for life-saving hepatitis C drug
16 April 2014 - 17:37 

"The recommendation of NHS England’s Clinical Priorities Advisory Group (CPAG) means that whilst not yet NICE-approved, Sofosbuvir will be funded for those patients at significant risk of mortality or who require transplantation."

NHS England has approved an £18.7 million investment in a new drug for the treatment of hepatitis C.

Around 500 patients with acute liver failure, and/or awaiting liver transplantation, are expected to benefit from the decision to fund Sofosbuvir.

The hepatitis C virus causes inflammation of the liver, affecting its ability to function. Whilst many sufferers naturally clear their infections within six months, others develop chronic hepatitis which is usually life-long without therapy.

Current estimates indicate that around 30% of people infected with chronic hepatitis C will develop cirrhosis of the liver which, in some cases, may prove fatal without a liver transplant.

The recommendation of NHS England’s Clinical Priorities Advisory Group (CPAG) means that whilst not yet NICE-approved, Sofosbuvir will be funded for those patients at significant risk of mortality or who require transplantation.

View NHS England’s policy statement on the funding of Sofosbuvir. The drug, which will be available as an oral formulation, will be used in combination with another antiviral agent.

James Palmer, Clinical Director, Specialised Services, said:

“This is a major step forward for patients with this debilitating, and often life-threatening, disease and is evidence of NHS England’s commitment to widen access to cutting edge drugs, treatments and therapies where both clinically appropriate and cost effective.

“The majority of these patients will already be under the care of a specialist treatment centre, and we will ensure that clinicians are aware of this policy, so that all eligible patients have the opportunity to access this drug”.

Professor Graham Foster, Professor of Hepatology and co-Chair of the Hepatitis C Clinical Reference Group sub-group welcomed the news. He said:

“The recently licensed, new, direct-ac ting antiviral drugs for hepatitis C may be life-saving for infected patients with advanced cirrhosis. I am delighted that NHS England will make these drugs available for these patients and allow us to treat those in urgent need.

“The availability of these drugs will ensure that NHS patients are among the first in Europe to benefit from these revolutionary new drugs”.

NICE is currently developing Technology Appraisal Guidance relating to Sofosbuvir, which is due to be published later this year. The NHS England policy position will be reviewed once NICE has published this guidance.

Source - NHS

Nick Harvey: There’s now a cure for hepatitis C… but the poor can’t afford it

Nick Harvey: There’s now a cure for hepatitis C… but the poor can’t afford it
15 Apr, 14 | by BMJ

Picture the scenario: a disease is destroying your liver and there’s a chance you will die. There’s a cure, but you can’t have it as it costs more than you earn. There are tens of millions more of people like you. Hundreds of thousands of them die every year.
It sounds like some sci-fi dystopia, but this is the situation that the 150 million people who have hepatitis C virus (HCV) find themselves in today. HCV is spread through blood-to-blood contact, mostly through shared needles. Around 350,000 people die of HCV related liver complaints each year, but new drugs have been developed within the last six months with cure rates higher than 90 per cent.
Big pharmaceutical companies such as Gilead are pricing it up to $84,000 (£50,000)—that’s $1000 (£600) a pill.....
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ViewPoints: Competitor dynamics shift in hepatitis C market


ViewPoints: Competitor dynamics shift in hepatitis C market

(Ref: ViewPoints Desk)
FirstWord Pharma
April 15th, 2014
By: Simon King 

Continued rapid uptake of Gilead Sciences' hepatitis C treatment Sovaldi and questions surrounding the sustainability of pricing models in conjunction with demand for new therapies, provided the backdrop for this year's annual meeting of the European Association for the Study of the Liver (EASL) in London.

Clinical data presented at the conference showcased both the next generation of hepatitis C therapies – designed to further improve convenience and raise the standard of care for harder to treat patients – and the evolution of competitor dynamics, with Merck & Co. a notable winner in the eyes of analysts.

Insight, Analysis & Opinion

Presentation of Phase II data last week for Merck's combination of MK-5172 and MK-8742 prompted a flurry of revenue upgrades for the regimen among analysts. A widely held view is that should results hold up in larger Phase III studies, then Merck will not only emerge as a notable competitor to AbbVie as the market's 'second player' but could challenge the previously assumed 'monopolistic' status of Gilead, noted analysts at Goldman Sachs.

This stems primarily from MK-5172/MK-8742 being dosed as a single, once-daily tablet like Gilead's Sovaldi + ledipasvir fixed-dosed combination, which is expected to be approved on or before its October 2014 PDUFA date.

While AbbVie's product comprises an arguably less convenient regimen, the emergence of Merck's data threatens to minimise Gilead's differentiation versus competitors, particularly if MK-5172/MK-8742 demonstrates effectiveness across multiple genotypes. At this stage any 'uniqueness' of Gilead's offering will be based around a shorter eight-week duration of therapy (versus 12 weeks for the Merck regimen).

That said, while there are only "a few innovations left in hepatitis C," note analysts at JP Morgan, Gilead remains at the forefront of the two key opportunities – a true pan-genotypic all-oral regimen and a four- or six-week regimen. Gilead's combination of Sovaldi and GS-5816 (a pan-genotypic NS5a inhibitor) is targeting both opportunities and will move into Phase III testing later this year.

Despite being at the forefront of hepatitis C innovation, analysts at Goldman Sachs have reduced their long-term sales forecasts for the company on the assumption that Merck will assume greater market share than initially anticipated. However, for some the bull thesis surrounding Gilead's potential dominance of the market remains firmly intact, given its likely head-start over competitors, particularly Merck whose drug will reach the market in late 2015 at the earliest.

Given the way that Sovaldi revenues have developed since December, debate around diagnosis rates and whether payers will stratify the hepatitis C population to better manage costs, accurately predicting the size of the market towards the end of the decade – let alone market share at a product level – remains challenging. The key takeaway from EASL is that the race for market share has become more competitive, a trend that will be watched with interest by payers.

Related @ HCV New Drugs
(Sovaldi, formerly GS-7977) and NS5A inhibitor ledipasvir (formerly GS-5885) based combinations, including: Sovaldi and GS-5816 alone without ribavirin
Sofosbuvir/Ledipasvir
Sofosbuvir/Ledipasvir and GS-9669
Sofosbuvir/Ledipasvir and GS-9451
Sovaldi and GS-5816
alone without ribavirin


Related @ FirstWord Pharma
ViewPoints: Pharmacy benefit managers threaten to run with Congress' baton on Sovaldi pricing – Is Gilead Sciences a victim of its own success?

Spotlight On: The Sovaldi pricing debate – 5 key questions

Doctors, medical staff on drugs put patients at risk

Doctors, medical staff on drugs put patients at risk
By Peter Eisler 
A single addicted health care worker who resorts to “drug diversion,” the official term for stealing drugs, can endanger thousands. Nearly 8,000 people in eight states needed hepatitis tests after David Kwiatkowski, an itinerant hospital technician, was caught injecting himself with patients’ pain medicine and refilling the syringes with saline. He infected at least 46, mostly in New Hampshire.
It was the third hepatitis outbreak since 2009 linked to a health care worker using patients’ syringes (the others were in Denver and Jacksonville, Fla). And for each of those worst-case scenarios, there are countless more practitioners whose drug-related errors are more isolated — a botched surgery, an incorrect dose of medication, a worrisome vital sign missed.
Continue reading....