Friday, October 31, 2014

At The Crossroads: The Rise Of Hepatitis C And The Fight To Stop It

A new series from Rhode Island Public Radio
At The Crossroads: The Rise Of Hepatitis C And The Fight To Stop It

Program Update Oct 29
Providing medical assistance to low income Rhode Islanders will cost the state more than projected. One of the major factors behind the increase is the cost of two new drugs.                   
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Addiction usually leaves a wake of chaos, and all kinds of casualties - marriages, jobs, health. Most tragically, the current crisis of opioid addiction (to prescription painkillers and heroin) in Rhode Island has cost too many lives. Well over 160 Rhode Islanders have died from accidental opioid overdoses so far this year. Hundreds more might have joined them had it not been for the rescue drug naloxone.
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About the series:
Hepatitis C infects an estimated five million Americans, though most of them don’t know it. But deaths from hepatitis C are on the rise in baby boomers. And throughout New England, new infections are creeping up among a younger generation. Less than a year ago, their only options for treatment were complicated regimens of injections that didn’t always lead to a cure. But brand new drugs could change everything. That is, if the cost doesn’t break us.

This series was produced by Kristin Gourlay, and edited by Catherine Welch, as a project for The California Endowment Health Journalism Fellowships, a program of the USC Annenberg School for Communication and Journalism.

Support for health care reporting on Rhode Island Public Radio also comes from the Rhode Island Foundation, Rhode Island's only community foundation.

Jake Harper produced the infographics for "At the Crossroads."

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Thursday, October 30, 2014

Express Scripts Says AbbVie (ABBV)'s Drug Could Displace Gilead Sciences, Inc. (GILD)'s Sovaldi On Formulary

Express Scripts Says AbbVie (ABBV)'s Drug Could Displace Gilead Sciences, Inc. (GILD)'s Sovaldi On Formulary

By Riley McDermid, Breaking News Staff 

The price war between dueling hepatitis C drugs added another skirmish Thursday, after pharmacy benefit manager Express Scripts Holding Co said it will likely change its standard formula to a new, cheaper unnamed AbbVie (ABBV) product instead of choosing Gilead Science (GILD)’s pricey Harvoni or Sovaldi treatments. "The cost of [Sovaldi] is unsustainable for many of our plans," Steve Miller, chief medical officer of Express Scripts, told analysts late Wednesday. The company is the largest U.S. pharmacy benefit manager and also runs large mail order pharmacies. AbbVie is hoping to have its new treatment approved by American drug regulators later this year.

Express Scripts pointed out that many public health programs like Medicaid and state prison systems currently foot the bill for the $94,500 price tag of Sovaldi, which has a cure rate of around 90 percent. Because the poor and incarcerated are more likely to suffer from the debilitating liver disease, that high cost can affect them disproportionately, said Miller. 

"(We) are hoping [AbbVie will] take a different approach when it comes to pricing," Miller said.

In addition, AbbVie’s new product is also considered more convenient, because it combines three drugs into a single, once-a-day pill. In contrast, Sovaldi and Harvoni sometimes have multiple stages of treatment, and cost $94,500 and $84,000 per course—or around $1,000 per pill.

Chicago-based AbbVie’s new pill would also not need to be combined with the sometimes-toxic drug interferon.

Express Scripts spokesman Brian Henry told Reuters that the Gilead drugs could be removed entirely from its formulary if the AbbVie drug can be shown to be as effective at treating hepatitis C.
- See more 

Wednesday, October 29, 2014

117,000 hepatitis C patients receive Sovaldi so far

117,000 hepatitis C patients receive Sovaldi so far

Breakthrough drug has made $8.5bn for Gilead this year

Gilead Sciences' blockbuster hepatitis C drug Sovaldi has been used in around 117,000 people since its launch at the end of last year, said the company in its latest financial report.

Sovaldi (sofosbuvir), which allows patients to be treated without the need for weekly injectable interferon, has been the most lucrative pharma launch of all time, and has recorded revenues of $8.5bn in the first nine months of 2014 and $2.8bn for the three-month period between July and September.

This uptake has been despite criticism from some corners of the US unhappy with the drug's high price – around $84,000 per standard course of treatment – with senators asking Gilead to justify the cost of Sovaldi.

Around 70% of US state Medicaid programmes have implemented controls on Sovaldi prescribing - including prior authorisation requirements based on disease severity - amid warnings that some healthcare systems may buckle under the strain of providing the drug.

Nevertheless the massive revenues so far put Sovaldi way ahead of Gilead's second biggest selling medicine Atripla, a combination of several HIV treatments. The drug made $2.5bn for the first nine months of the year and just under $900m over the third quarter, both slightly down on the same periods last year.

The huge boost from Sovaldi saw Gilead's total revenues rocket from $8.1bn for the first nine months of 2013 to $17.5bn for the same period in 2014.

Net income was also up, with Gilead taking $8.6bn for the first nine months of 2014 compared to $2.3bn a year previous.

Company revenues should continue to grow with the upcoming launch of Harvoni, a combination of Sovaldi and other hepatitis C treatment ledipasvir.

The drug was recommended for use in Europe at the end of September and approved in the US a couple of weeks later and expectations are high, with trial data demonstrating the drug can cure as many as 90% of patients within just eight weeks.

Tuesday, October 28, 2014

Insurers May Cover Costly Hepatitis C Drugs Only For The Very Ill

Insurers May Cover Costly Hepatitis C Drugs Only For The Very Ill

Tuesday, October 28, 2014

In the past year, hepatitis C drugs that promise higher cure rates and fewer side effects have given fresh hope to millions who are living with the chronic liver disease.

But many patients whose livers haven't been significantly scarred by the virus face a vexing reality: They're not sick enough to qualify for the drugs that could prevent them from getting sicker.

An estimated 3.2 million people are infected with hepatitis C virus. Many public and private insurers are restricting access to treatment to those who already have serious liver damage. The treatment cost per patient is roughly $95,000 or more for a 12-week course of treatment.

Other strategies that limit access include restricting who can prescribe the drugs or requiring early proof the drug is working before continuing with treatment. In addition, many state Medicaid programs require that patients be free of drugs and alcohol for a period of months before they can get the hepatitis C drugs.

"Everybody is trying to figure out how best to deliver needed treatments without blowing out resources because of the cost," says Brendan Buck, a spokesman for America's Health Insurance Plans, a trade group. AHIP has been an outspoken critic of high prices for specialty drugs, including those for hepatitis.

Gilead Sciences, maker of hepatitis C drugs Sovaldi and Harvoni, said no one was available to comment by deadline. But the company provided information about pricing and a policy brief that states, "The price of Gilead's hepatitis C treatments reflects the significant clinical, economic and public health value of these drugs, and is comparable to, or in many cases less than, the cost of older, less effective regimens."

Insurers base their coverage decisions in part on practice guidelines issued by clinical groups such as the American Association for the Study of Liver Disease,. which recommends giving patients with advanced liver disease priority in treatment. "Limitations of workforce and societal resources may limit the feasibility of treating all patients within a short period of time," the organization said in a statement when the recommendations were announced.

Paul Walker is one of the healthy ones. Diagnosed with hepatitis C in 1998, the 53-year-old Tyler, Texas, resident had a biopsy this year that showed only slight evidence of scar tissue that can cripple the liver, eventually resulting in cirrhosis or liver cancer.

Walker's doctor prescribed Sovaldi, a pill approved by the Food and Drug Administration in December that can cure the chronic infection in 12 weeks, significantly faster than the nearly year-long course of treatment often required under older drug regimens.

Sovaldi is taken with another hepatitis C drug such as interferon, which can cause flu-like symptoms, nausea and depression and which adds to the cost. Instead of interferon, Walker's physician prescribed Olysio, another recently approved hepatitis C drug that is popular among physicians. But its use in combination with Sovaldi for cases like Walker's hasn't been approved by the Food and Drug Administration.

Walker's insurer, Blue Cross Blue Shield of Texas, denied his physician's request for the drug. The insurer cited the off-label use of Olysio in its denial.

"We are committed to providing our members access to quality, cost-effective medications," Dan McCoy, chief medical officer for Blue Cross Blue Shield of Texas, said in a statement. "Our coverage criteria is based on clinical trial data, published literature and recommendations from a wide variety of medical specialty societies." The insurer didn't respond to a request for specific coverage criteria.

In October, the FDA approved Gilead's Harvoni, a daily pill that doesn't have to be taken with another drug. A typical 12-week course of treatment will generally cost about the same as for Sovaldi used with another drug (unless it's Olysio, which can push the total treatment cost to $150,000 or more). Patients like Walker might be cured in as little as eight weeks using Harvoni, however, slashing the cost by a third.

Walker says he hopes he'll be approved for Harvoni.

"Until I actually get the medication and am cured there's going to be a lot of anxiety," says Walker.

Copyright 2014 Kaiser Health News. To see more, visit

UPDATE 3-Aetna sees higher medical cost spending than expected

UPDATE 3-Aetna sees higher medical cost spending than expected
(Recasts to focus on medical costs)

By Caroline Humer

Oct 28 (Reuters) - Aetna Inc, the third-largest U.S. health insurer, said on Tuesday it expects 2014 medical costs to increase at the high end of its forecasts, underpinning investor concerns that years of stabilized medical use could be ending.

Shares in Aetna fell 2.2 percent and others insurers including UnitedHealth Group Inc and WellPoint Inc also fell.

Aetna said that in the third quarter, it experienced an unexpected rise in its medical cost ratio due to more spending on claims at companies with 50 to 300 employees, the price of new hepatitis C treatments, and the performance of the individual business.

The company said it expects spending to pick up during the fourth quarter, a typical seasonal trend that occurs as people reach their insurance deductibles.

Its 2014 medical spending trend forecast is now for an increase at the high end of the 6 to 7 percent range. For 2015, it said it is pricing premiums based on an expectation that spending will accelerate by another 50 to 100 basis points.

Investors have been watching medical cost trends closely for any reversal of the low use of medical services in recent years.

Some hospitals have reported an uptick in use driven by a rebound in the economy. Others have said medical services use is up because of implementation of the national healthcare reform law.

So far, Aetna said unexpected increases have been largely in areas like pharmaceutical cost and hospital outpatient use.

"I wouldn't say we have gotten to the point where we are drawing a conclusion that there is a widespread move upwards in medical cost trends," Aetna Chief Financial Officer Shawn Guertin said.

Aetna said third-quarter profit rose as the benefits of its Coventry government healthcare acquisition offset these higher medical costs.

Aetna said the percentage of premiums collected that it spent on covering medical services increased 0.5 percentage points to 81 percent in its commercial business, which includes new individual health plans. For commercial and government businesses combined, the ratio fell to 82.3 percent from 83.1 percent.

In 2014, Aetna began selling health insurance to individuals on the new healthcare exchanges created under the Affordable Care Act.

Aetna said it has almost 600,000 new insurance exchange customers and that they have higher costs per patient than expected. But it said it began making a slight profit on the business during the third quarter as high volume helped defray fixed costs.

Aetna reported net income of $594.5 million, or $1.67 per share, up from $518.6 million, or $1.38 per share, a year earlier. Revenue rose 13 percent to $14.7 billion, slightly above analysts' expectations.

Aetna said operating earnings were $1.79 per share excluding transaction costs, beating analysts' expectations of $1.58.

Aetna raised its 2014 earnings forecast to $6.60 to $6.70 per share from $6.45 to $6.60. (Reporting by Caroline Humer Editing by W Simon, Lisa Von Ahn and David Gregorio)

Regulatory News

Sunday, October 26, 2014

3 die after being administered SOVRIAD™ (simeprevir sodium) Hepatitis C drug

3 die after being administered hepatitis C drug

The health ministry said Friday three people have died after taking the hepatitis C drug Sovriad, and it has ordered the distributor to revise the drug packaging to say usage should stop when indicated by a patient blood test.

The ministry also ordered the maker and distributor, Janssen Pharmaceutical K.K., to notify doctors and hospitals in writing of the change.

The package insert already warns of possible deterioration of liver function from use of the drug, known generically as Simeprevir Sodium. The ministry directed the packaging also say usage should be discontinued if a blood test indicates certain abnormalities.

According to the Ministry of Health, Labor and Welfare, taking the drug will increase "bilirubin" by decomposing hemoglobin in the blood and may aggravate dysfunction of the liver and kidney.

Three patients in their 40s to 60s who were taking the drug died in connection with such symptoms, it said.

Since the drug was put on sale last December, about 19,000 people in Japan had used it by the end of September.

Friday, October 24, 2014

Hepatitis C Weekend Reading: "Not without a fight Kim!" A Mothers Story

Good day everyone, hope you all have a safe and enjoyable weekend. Tomorrow I begin a new chapter in my life, I'm moving across the state, only five minutes from my children and grandchildren. Here comes trouble!

I am so grateful to be healthy, after watching Kim Bossley share her story today on Second Opinion, I was reminded this morning of just how fortunate I am.

* I successfully treated HCV soon after being diagnosed in 2000 

Kim's Story and The Bonnie Morgan Foundation
Kim's story begins with her mother, Bonnie Morgan, who suffered with kidney disease since birth. Later in life when she needed a kidney transplant, Bonnie's mother Ruth proved to be a suitable match, the transplant was a success. Against all odds, three years after Bonnie's transplant, she gave birth to Kim, a mothers dream came true. Tragically, sometime later Bonnie found out both she and her child contracted hepatitis C through an earlier blood transfusion. The story continues, but should be read firsthand at The Bonnie Morgan Foundation, Co-Founded by Kim Morgan Bossley, in honor of her mother.

Full Episode 
PBS Program - Second Opinion
Kim Bossley on New York City's PBS show, Second Opinion. In addition Kim has published many wonderful articles online at

Thank you Kim for being such a strong voice for everyone living with and battling hepatitis C.

Hepatitis C Virus Infection as a Traumatic Experience

Hepatitis C Virus Infection as a Traumatic Experience

Mychelle Morais-de-Jesus, Renato Daltro-Oliveira, Karine Miranda Pettersen, Adriana Dantas-Duarte, Luciana Di-Domizio Amaral, Patrícia Cavalcanti-Ribeiro, Carlos Teles Santos, Maria Isabel Schinoni, Liana R. Netto, Lucas Araújo-de-Freitas, Raymundo Paraná, Ângela Miranda-Scippa, Karestan C. Koenen, Lucas C. Quarantini mail Published: October 23, 2014 •

DOI: 10.1371/journal.pone.0110529

The purpose of this study was to evaluate whether individuals consider their HCV infection to be a potentially traumatic experience. Additionally, we investigated its association with Post-Traumatic Stress Disorder (PTSD) and the impact of PTSD diagnosis on health-related quality of life (HRQoL) in HCV infected subjects.

We conducted a cross-sectional survey of 127 HCV-infected outpatients recruited at a University Hospital in Salvador, Brazil. All subjects answered an orally-administered questionnaire to gather clinical and socio-demographic data. We investigated traumatic experiences and the subject's perception of the disease using the Trauma History Questionnaire. PTSD and other psychiatric diagnoses were assessed through the Mini International Neuropsychiatric Interview-Brazilian Version 5.0.0 (M.I.N.I. PLUS). HRQoL was assessed using Short-Form 36 (SF-36).

Approximately 38.6% of the patients considered hepatitis C to be a traumatic experience. Of these, 60.7% had a PTSD diagnosis. PTSD was associated with significant impairment in quality of life for individuals in seven SF-36 domains as shown bymultivariate analysis: Role-Physical (β: −24.85; 95% CI: −42.08; −7.61), Bodily Pain (β: −19.36; 95% CI: −31.28; −7.45), General Health (β: −20.79; 95% CI: −29.65; −11.92), Vitality (β: −11.92; 95% CI: −20.74; −3.1), Social Functioning (β: −34.73; 95% CI: −46.79; −22.68), Role-Emotional (β: −26.07; 95% CI: −44.61; −7.53), Mental Health (β: −17.46; 95% CI: −24.38; −10.54).

HCV is frequently a traumatic experience and it is strongly associated with PTSD diagnosis. PTSD significantly impaired HRQoL.

Citation: Morais-de-Jesus M, Daltro-Oliveira R, Pettersen KM, Dantas-Duarte A, Amaral LD-D, et al. (2014) Hepatitis C Virus Infection as a Traumatic Experience. PLoS ONE 9(10): e110529. doi:10.1371/journal.pone.0110529
Infection with hepatitis C virus (HCV) is common throughout the world and can result in severe liver damage and failure. Worldwide, the most common route of HCV transmission is intravenous drug use. The main risk factors in Brazil are blood transfusions from non-tested blood donors, intravenous drug use, and invasive therapies with contaminated equipment [1]. Additional risk factors of HCV infection include perinatal infection, sexual transmission and activities with potential exposure to blood, such as tattoo and piercing. The disease can manifest in a wide spectrum of effects, ranging from various degrees of liver damage, syndromes of immunological origin — such as rheumatoid symptoms and cryoglobulinemia [2][4] — and neuropsychiatric disorders such as depression and cognitive deficits [5][12].

Psychiatric disorders are highly prevalent among HCV-infected patients, and have a well established effect on their well-being. PTSD is a common, debilitating, complex syndrome which occurs in some persons after personal exposure to a traumatic stressor or experienced by a family member or another close associate. Some of the main symptoms are intense fear, helplessness, persistent avoidance of stimulus associated with the trauma, increased arousal. [13]. “The full symptom picture must be present for over 1 month (Criterion E), and the disturbance must cause clinically significant distress or impairment in social, occupational, or other important areas of functioning” (DSM-IV). Populational studies show the disorder's prevalence to be around 6.8% in a study carried out in the United States [14] and 14% in another one carried out in Brazil [15]. PTSD is highly comorbid with many different medical and psychiatric illnesses and can be underestimated in non-clinical populations [15][17]. It is also associated with significantly low rates of HRQoL [18], [19]. PTSD has already been cited in HCV populations in a small number of studies, most of which were primarily focused on other specific populations, such as veterans, HIV co-infected persons, and persons on dialysis [20][25].

Patients carrying the virus usually have a lower health-related quality of life (HRQoL) when compared with a reference population [26][28], even in the absence of severe hepatic disease [29], [30]. HRQoL is a multidimensional concept embracing an individual's perception of their own well-being in terms of: physical functioning; role-physical; bodily pain; general health; vitality; social functioning; role-emotional; and mental. This concept is based on the World Health Organization's definition of health as “A state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity” [31].

The cause of the reduced HRQoL in asymptomatic HCV-infected patients is not well understood and may have a multifactorial origin. Fatigue and other symptoms of a neuropsychiatric nature, like forgetfulness, depression and difficulty concentrating, are common complaints of HCV-infected patients [5], [29]. These patients also perform more poorly on neuropsychiatric tests [5], [32], [33], suggesting the virus may act on the nervous system. Evidence of HCV replication in the central nervous system [34], [35] supports this hypothesis. HRQoL is also improved in patients who achieve sustained virological response after antiviral therapy [36][38].

Another line of research considers that personal background may affect HRQoL due to low household income, intravenous drug use, coexistent co-morbidities, knowledge of diagnosis, and other factors associated with acquiring the infection [39], [40].

Patients with a comorbid psychiatric disorder and HCV-infection are well documented to have reduced HRQoL [41], [42]. The impact of depression on HRQoL in these patients is well-investigated [43], [44]. However, the relationship between post-traumatic stress disorder (PTSD) and HCV infection, and their combined consequence on HRQoL, is not well studied.

Accordingly, this study aimed to evaluate whether HCV-infected individuals consider their HCV infection to be a potentially traumatic event, and its association with PTSD diagnoses. The secondary objective is to investigate the relationship between PTSD diagnosis and HRQoL in HCV-infected patients. We hypothesized that, among hepatitis C patients, there is a perception of hepatitis C disease as a potentially traumatic experience, as well as an association between PTSD diagnosis and poorer HRQoL.

Materials and Methods
Ethics statement
Ethical approval for this study was obtained from the local MCO – UFBA, Institutional Review Board (IRB) (protocol 14/2002) and it is in accordance with the Helsinki Declaration of 1975. Prior to any data collection and after a complete description of the research, written informed consent was obtained from the patients who agreed to participate. All subjects answered an orally-administered questionnaire to gather clinical and socio-demographic data.

Subjects and data collection
We conducted a cross-sectional survey with chronic hepatitis C outpatients from the University Hospital (Com-HUPES) – Federal University of Bahia (UFBA) between June 2009 and July 2012. We included all patients older than 18 years of age in consecutive order. A total of 127 patients diagnosed with chronic hepatitis C were enrolled in the study (men = 82, women = 45). The samples were divided into ninety-nine HCV-control subjects (78%) and twenty-eight HCV-PTSD subjects (22%).

Measurement Instruments
We used the Trauma History Questionnaire (THQ), a 24-item self-report measurement, to assess subjects' history of traumatic life events. The adaptation of the scale for Portuguese met the criteria of semantic and operational equivalences [45]. The THQ is suitable for clinical and research environments. Traumatic experiences were classified into the following categories: “crime-related events”, “general disaster and trauma”, “physical and sexual experiences”, and “other events”.
The subjects were also asked about the frequency of the event and their ages when it occurred.
In addition to the analysis of these four types of traumatic experience, subjects who answered “Yes” to question fifteen were analyzed separately: “Have you ever had a serious or life-threatening illness? If yes, please specify.” This question investigated whether the patient considered hepatitis C to be a stressful, life-threatening experience that was experienced as a potentially traumatic event, and may be associated with PTSD.

Axis I clinical syndromes were diagnosed using the Mini International Neuropsychiatric Interview-Brazilian Version 5.0.0 (M.I.N.I. PLUS), a short, structured diagnostic interview compatible with DSM-IV and ICD-10 criteria [46].

Quality of life was assessed using Short-Form 36 (SF-36) [47]. SF-36 has been used for numerous studies all over the world in order to assess quality of life, and has been translated and validated in Brazil. The scale was translated and made suitable for the socio-economic and cultural Brazilian conditions, where validity and reproducibility were demonstrated [48]. The HRQoL was measured by eight domains: physical functioning; role-physical; bodily pain; general health; vitality; social functioning; role-emotional; and mental health. The final scores in each domain were adjusted linearly from 0 to 100 via the formulas found in SF-36; a score of “0” indicates the worst health status, a score of “100” indicates the most favorable health status.

All interviews were conducted face-to-face by trained mental health professionals. Kappa index (proportion of agreement beyond probability divided by the agreement potential) was used to obtain reliability. Every patients' disorder was recorded and fulfilled the criteria, according to this tool. The Kappa index analysis among observers in the M.I.N.I. was 0.9.

Data Analysis
Statistical analysis was conducted with STATA 9.0 software. The subjects were divided into two groups according to diagnosis for post-traumatic stress disorder: HCV without PTSD symptoms (HCV-control) and HCV with a diagnosis of PTSD (HCV-PTSD). The following independent variables were selected with the objective of performing descriptive analyses between these groups: gender, age, civil state, occupation, transplant eligibility, presence of medical comorbidity, number of medical comorbidities, presence of psychiatric comorbidity and number of psychiatric comorbidities. Chi-Square and Kruskall-Wallis tests were used to compare categorical and continuous variables, respectively, between HCV-control and HCV-PTSD groups.

To evaluate whether any THQ categories or a positive response to question fifteen of THQ were independently associated with the severity of disease (determined by transplant eligibility) or a diagnosis of PTSD, the Pearson test was used.

Bivariate analyses were carried out to verify the possible differences between PTSD diagnosis and HRQoL scores through the non-parametric Pearson test. In order to control for potential confounding factors, a multivariate analysis was performed by a robust linear regression model that allowed us to estimate the increment (or decrement) yield (β) when patients with PTSD were compared with the reference group, patients with a negative PTSD diagnosis.

All tests were performed using the significance level of 5% (p≤0.05).

The HCV-control group was predominantly male (68.7%), ranging in age from 23 to 68 years (mean = 53±8.8); most subjects had a stable partner (64.65%); over 69% had a paid occupation; 49% were eligible for a liver transplant; 44.1% had some decompensated or systemic medical comorbidity; and 50% had a psychiatric comorbidity (Table 1). On the other hand, the HCV-PTSD group had a balanced gender variable (14 male and 14 female), and ranged in age from 28 to 65 years (mean = 52±9.27); 53.57% were in a civil partnership; most had a paid occupation (75%); 78.57% were not eligible for a transplant; 42.86% had a decompensated or systemic medical comorbidity; and 71.43% had another psychiatric comorbidity. Significant differences between groups were found through bivariate analysis on the variables: civil state (p = 0.03) and number of psychiatric comorbidities (p = 0.002) (Table 1).

Table 1. Socio-demographic and clinical characteristics.

The experiences of: “crime-related events,” “general disaster and trauma,” and “other events” showed no significant association with the development of PTSD diagnosis, unlike “physical and sexual experiences,” which showed a significant association (p = 0.019). Of all subjects, 38.6% considered hepatitis C to be a traumatic experience. Of these, 60.7% had a PTSD diagnosis. The perception of hepatitis C as a traumatic experience was not associated with disease severity (needing a transplant), however it showed a significant association with diagnosis of PTSD (p = 0.003).

Bivariate analysis revealed a negative impact of PTSD symptoms in the following SF-36 domains: role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Multivariate analysis reported a negative association in the following domains: role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health, that remained significant even after adjusting for confounding factors (Table 2).

Table 2. Bivariate and Multivariate Analysis of PTSD diagnosis and Quality of Life in Chronic Hepatitis C Patients.

DiscussionFor our knowledge, this is the first study demonstrating HCV as a traumatic experience strongly associated with PTSD. The prevalence of PTSD in this sample was 28%, which is extremely high compared to mean prevalence in the general world population, ranging from 0% to 10.4% [49]. A recent survey carried out in Brazil, in the two largest cities in the country, São Paulo and Rio de Janeiro, has estimated the prevalence of PTSD in one year to range between 1.2% and 7.8% [50].
Our finding that a high proportion of HCV patients considered the condition to be a potentially traumatic experience is consistent with previous studies investigating severe acute respiratory syndrome (SARS) [51] and myocardial infarction [52], which are both recognized as potentially traumatic events that may lead to post-traumatic stress syndrome. However, one limitation of the survey is that the trauma can be influenced by the fear of death or stress of living with an illness, since the question “Have you ever had a serious or life-threatening illness?” can be interpreted differently by each patient.

The disease severity was not significantly associated with either the perception of hepatitis C as a traumatic experience or PTSD diagnosis. Contrary to our expectations, disease severity showed a tendency of negative association with PSTD diagnosis. This unexpected result is possibly related to the small sample size, and requires further investigation.

Even after adjusting for psychiatric comorbidities, PTSD was associated with quality of life scores significantly lower in seven of the eight SF-36 domains, as shown by bivariate and multivariate analysis. Similar results were found in other studies that analyzed quality of life in individuals diagnosed with PTSD symptoms [53], [54], including individuals with a past diagnosis of non-recurring PTSD [55]. Therefore, PTSD is related to impaired mental and physical health as well as increased healthcare utilization [56].

Consistent with other studies [57], there was a higher prevalence of PTSD diagnosis in female subjects (45.16%) compared to males (20.58%). The prevalence of psychiatric disorders in both HCV-control and HCV-PTSD groups was high, especially the latter, which is in accordance with previous clinical studies regarding individuals infected with hepatitis C [10], [43]. The HCV-PTSD samples had a prevalence of psychiatric disorders 49% higher on average than the general Brazilian population, according to estimates from epidemiological studies of the general population [58]. Although the majority of the studies relating PTSD to HCV patients has been conducted with veterans and HIV co-infected patients, this study had only two HIV co-infected patients and no veterans.

The mode of HCV contraction is potentially an important variable to explain some of the trauma; therefore it is important to highlight that a previous study in the population of Bahia, Brazil, found that the most common route of HCV infection is through unscreened blood transfusions [42].
Furthermore, none of the patients cited it as a traumatic experience when they were asked about the history of potentially traumatic experiences through the Trauma History Questionnaire.

The findings of this study should be interpreted with consideration of the following methodological limitations: the cross-sectional design may cause bias for assessment of other psychiatric correlations with PTSD. Since stigmatization is an important phenomenon in the HCV-infected population [59][61], patients may, as an avoidance behavior, under-report their psychopathology. The study design also made it impossible to know whether the perception of HCV as a traumatic experience was impacted by pre-existing PTSD, or was the source of the PTSD itself. Finally, the small sample size of this study may limit the power to detect association factors with moderate strength.

This study contributes to HCV being perceived as a traumatic experience and, furthermore, reveals a high prevalence of PTSD among HCV-infected patients. Our findings show that considering a subject's perception of HCV as a traumatic experience may help to detect PTSD; a condition with significant HRQoL impairment.

The authors thank all the patients who agreed to be included in this study for their cooperation. We are also grateful to Clarissa Rocha Leite, Sofia Senna-Gonçalves and Rafaela A. Lima for their technical assistance. We thank Dr. Carmine Pariante who kindly reviewed this manuscript.

Author Contributions
Conceived and designed the experiments: MMJ RDO KMP ADD LDA PCR CTS MIS LRN LAF RP AMS KCK LCQ. Performed the experiments: MMJ RDO KMP ADD LDA CTS LCQ. Analyzed the data: MMJ RDO CTS KCK LCQ. Wrote the paper: MMJ RDO PCR LRN LAF RP AMS KCK LCQ.

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