July 10, 2013

The threat of a new epidemic

by John Coulter | Coulter is vice president, Molecular Diagnostics, at Abbott.

Tuesday, July 9, 2013

A public health problem decades in the making, hepatitis C (HCV) has become a leading viral killer in the U.S., slyly growing in prevalence under the radar of both patients and the American public.

A disease that once may have been scarcely thought of, HCV is now commonplace and costs the U.S. more than 15,000 lives and nearly $11 billion each year. In recent years, government agencies such as the Centers for Disease Control and Prevention and nonprofit groups have been working overtime to alert the public through events such as World Hepatitis Day, which is held annually on July 28.

In Roanoke, the New River Valley and throughout Southwest Virginia, demographic trends reflecting an aging population put residents of the state at risk. With as many as one in 30 U.S. baby boomers (adults born 1945-1965) infected with HCV and at least 800,000 of these unaware they’ve contracted the virus, it’s no surprise the CDC now recommends HCV screening for baby boomers.

More recently, the U.S. Preventive Services Task Force recommended all baby boomers get tested for HCV, sending a clear signal to health care professionals, policy makers and the public that screening for HCV is beneficial for both patients and the public health.

Increasingly, conversations about a variety of medical concerns — cancer, diabetes and mental health, for example — are driven by deeper understandings of the genetic structures of illnesses.

Less frequently talked about among stories of amazing science and revolutionary care, however, is how molecular testing is helping the U.S. face one of its biggest infectious disease challenges.

As our nation battles a burgeoning HCV epidemic, it’s important to recognize the everyday significance molecular testing plays in battling this long-silent killer. Molecular testing enables a more clearly mapped battleground on an individualized basis, and that’s just a part of how diagnostics is reshaping the health community’s approach to HCV.

Health experts fighting HCV have identified six major genetic variations, or genotypes, and more than 50 subtypes of HCV.

The genetic spectrum of HCV is as diverse as the boomer generation itself, but make no mistake about it, anyone of any age, race or gender can contract any genotype or subtype of HCV. With the same DNA sequencing principles used to determine hereditary predisposition for some types of cancers, companies like mine have pioneered systems that provide physicians with HCV genotype identification for each patient.

This information is vital in determining how to treat each patient individually, since each genotype of the virus responds to treatment differently. A recent article in the New England Journal of Medicine illuminated this fact by mapping genotype-specific responses to current and developing therapies. Armed with genotyping data for each patient, doctors can prescribe the treatment that is most likely to be successful and help avoid side effects from less targeted, less effective treatments.

From the early 1990s, when we introduced a pioneering assay to protect our nation’s blood supply from hepatitis, to today’s technology that helps identify genotypes faster, diagnostics have helped offset the global HCV burden and create early warning systems for both patients and doctors. Getting tested for HCV is critical for adults, especially those who fall within the CDC’s recommended guidelines.

However, the journey to wellness in battling HCV goes beyond just getting tested. Our ability to understand the genetic makeup of the virus — thanks to advanced diagnostics — and to respond with appropriate treatment options brings new empowerment to the fight against the HCV epidemic. Molecular diagnostics allow us to zoom in on HCV and, in doing so, make this public health challenge an increasingly personal one.


Half a Diagnosis: Gap in Confirming Infection among Hepatitis C Antibody-positive Patients

The American Journal of Medicine

Article in Press

Emily McGibbon, MPH, Katherine Bornschlegel, MPH, Sharon Balter, MD

New York City Department of Health and Mental Hygiene, Long Island City, NY

published online 19 June 2013.
Corrected Proof



Recent guidelines recommend testing all individuals born during 1945-1965 for hepatitis C virus (HCV) antibody. For antibody-positive patients, subsequent RNA testing is necessary to determine current infection status. This study aimed to assess whether clinicians order HCV RNA tests as recommended for antibody-positive patients and to identify barriers to such testing.


We sampled individuals newly reported to the New York City Department of Health and Mental Hygiene's HCV surveillance system and collected information from clinicians. For patients without RNA test results, we asked the reason an RNA test was not ordered and requested that the clinician order the test.


Of 245 antibody-positive patients, 67% were tested for HCV RNA (for 21% of these, the test was ordered only after our request); 33% had no RNA testing despite our request. Patients without RNA testing were seen in medical facilities (47%), detox facilities (30%), and jail/prison (15%). Reasons RNA testing was not done were that the patient did not return for follow-up (35%), the facility does not do RNA testing (22%), and the patient was tested in jail (15%).


In our study, one third of patients did not get complete testing for accurate diagnosis of HCV, which is essential for medical management. Additional education for clinicians about the importance of RNA testing may help. However, with improved antiviral treatments now available for HCV, it is time for reflex HCV RNA testing for positive antibody tests to become routine, just as reflex Western blot testing is standard for human immunodeficiency virus.

Keywords: Hepatitis C, Surveillance, Testing


Patients in Transition

Avoiding Detours on the Road to HIV Treatment Success

Baligh R. Yehia, Shreya Kangovi, Ian Frank

AIDS. 2013;27(10):1529-1533.


To fully benefit from antiretroviral therapy (ART), people living with HIV (PLWH) need to be aware of their HIV infection, linked to and engaged in regular HIV care, and must receive and adhere to ART.[1,2] Completion of all these steps is often unsuccessful, with only 28% of all PLWH in United States achieving viral suppression.[3] Our current understanding for improving health behaviors (linkage to care, retention in care, ART receipt and adherence) and outcomes (viral suppression, prevention of AIDS-defining conditions, transmission of HIV, and survival) relies on modifying patient and environmental factors.[1] (Fig. 1) However, this framework is static and does not account for patients in transition.


Figure 1.

Revised behavioral model for people living with HIV. Adapted from [1].

Helping patients negotiate transitions is essential for HIV treatment success. Transitions of care are defined as the movement of patients between different levels of care, healthcare locations, or providers. They can occur within the same setting (e.g. hospital) or between settings (e.g. hospital to outpatient care), and usually represent changes in health status or social state.[4–6] Transitions are inherently difficult for patients, but are particularly challenging for PLWH who face high rates of poverty, mental illness, and confront HIV-related stigma and discrimination.[7] Emerging data suggests that transitions of care are important determinants of patient behaviors and outcomes.[8–12]

Transitions of Care Impact Health Behaviors and Outcomes

For PLWH, commonly encountered transitions include transfers from inpatient to outpatient care, correctional institution to community-based care, and pediatric/adolescent to adult clinic. HIV-infected patients are at increased risk of medication errors when transitioning from inpatient to outpatient care given their complex medication regimens, multiple comorbidities, and interactions with inpatient providers who may lack experience with HIV infection and ART.[13] Direct communication between hospital physicians and primary care providers occur in only 3–30% of all hospital discharges, and discharge summaries are infrequently available at the time of first postdischarge visit.[14] This lack of communication may lead to ART medication errors and unrecognized drug–drug interactions, resulting in harmful side effects, development of drug resistance, and treatment discontinuation.[13]

In transitioning from correctional institution to community-based care, released inmates must contend with a variety of new concerns, including reconnecting with family, securing housing and employment, obtaining health insurance, and establishing outpatient HIV care.[15] These sudden shifts in socioeconomic and healthcare factors compromise health outcomes for many PLWH transitioning from prison back to the community.[8,9] Among 2115 HIV-infected inmates on therapy, only 18% fill an initial prescription for ART within 30 days of release, and 30% within 60 days.[8] Reincarcerated PLWH who were on ART prior to release experienced a decrease in CD4 cell count by 80 cell/μl and an increase in HIV viral load by 1.14 log10 copies/ml compared to their last recorded prison measure.[9]

Adolescents and young adults transitioning from pediatric/adolescent to adult HIV care face changes in delivery of care, health information, and developmental stage. Youth living with HIV are accustomed to an interdisciplinary approach to care.[5] This contrasts with the adult care model, where medical, mental health, and social services are often fragmented, requiring more independent navigation of the healthcare system. Youth in transition must also confront the discrimination, stigma, and fear associated with disclosing their HIV status to new providers and other patients.[16] Among a cohort of young adults transitioning from pediatric/adolescent to adult care, immune function trended downward, 45% of patients reported that the transition was more difficult than expected, and 32% could not find emotional support services.[10] Lastly, adult care necessitates more autonomous, self-directed management of HIV infection compared with pediatric/adolescent care. Many pediatric programs utilize unique adherence tools such as mobile phone short message service (text messaging) to encourage compliance with HIV care and treatment.[17] Loss of this, and other support, may compromise retention in care and adherence to therapy for patients with differing levels of developmental readiness to transition.

The Dynamic Behavioral Model

To account for the effects of care transitions on health behaviors and outcomes, we introduce the Dynamic Behavioral Model. (Fig. 2) This new framework differs from prior models in several ways. First, it illustrates the interconnected relationship between patient and environmental factors. Many factors (e.g. transportation issues, availability and use of mental health services, and patient-provider concordance) do not belong in one domain, but rather involve both the patient and their environment. Second, this model highlights key factors which change as patients move from one care setting to another, namely socioeconomic status, access to care, developmental stage, health information, and delivery of care. Capturing this change is critical, because the relative difference between factors may be as important as the absolute state. For example, among 159 934 adult respondents to the 2004–2009 National Health Interview Survey, newly uninsured individuals were almost twice as likely to use emergency care services compared with continuously uninsured adults.[18] This change in access to care (i.e. losing insurance) had a greater impact on patient behavior than no change at all. Lastly, the Dynamic Behavioral Model provides a framework for understanding the movement of PLWH between differing healthcare settings and can be used as a tool to help manage transitions in care.


Figure 2.

Dynamic behavioral model for people living with HIV.

Managing Healthcare Transitions for People Living With HIV

Successful transitions require all stakeholders – patients, providers, and caregivers – to anticipate future challenges and develop feasible solutions (). Changes in socioeconomic status (e.g. loss of housing, employment, or financial resources) and access to care (e.g. loss of insurance or primary provider) are commonly encountered by patients transitioning from one setting to another. Case management and patient navigation, employing community health workers to support and guide patients through the healthcare system, are effective at decreasing some of these obstacles to care.[19] Among 437 HIV-infected patients with housing, insurance, and structural barriers to care, patient navigation increased the proportion of patients with an undetectable viral load by 50% and the proportion of patients retained in care by 15%.[19] Utilizing social support services during transitions may help patients address changes in socioeconomic status or access to care.

Table 1.  Challenges and potential solutions for HIV-infected patients in transition.

Transition domain Changes between care settings Examples Potential solutions
Socioeconomic status Housing Employment Prisoner needs to find housing upon release. Address any competing needs (lack of housing, insurance, or social support) in conjunction with social workers and case managers.
Development Developmental stage Adolescent transitioning from pediatric/adolescent to adult care must manage HIV infection alone. Provide developmentally appropriate coaching for self-care prior to transitions.
Arrange a pretransfer visit where a receiving team member meets with the patient and the sending team prior to transfer and explains care delivery in the new setting.
Access to care Health insurance

HIV provider

HIV medications
Prisoner needs to obtain insurance for antiretroviral therapy and to reestablish primary care. Utilize social workers to help obtain health insurance.
Employ patient navigators to assist in arranging outpatient appointments and to ensure adherence to care.
Health information Medications

Treatment plan

Disclosure of HIV status to new individuals/providers
Inpatient providers need to communicate changes in antiretroviral and prophylaxis medications to outpatient providers. Sending team includes relevant data elements in transfer summary, such as changes to medications.
Delivery of care Level of patient autonomy

Integration of services

Support services
Community-based healthcare is more fragmented than institutional-based healthcare, necessitating independent navigation of the healthcare system. Use pretransfer visits and patient navigators to help individuals adjust to and navigate the new healthcare environment

Assessing patient readiness, promoting medical independence, and engaging caregivers are considered critical elements to successfully transitioning youth from pediatric/adolescent to adult HIV care.[5,10,16,20] New tools are needed to help providers manage the developmental aspects of care transitions. Specifically, programs aimed at assisting adolescent patients in developing the necessary skills for independently managing their own healthcare.

Effective transfer of health information is necessary for a successful care transition. The sending team must communicate relevant, accurate, timely, and patient-centered information, whereas the receiving team is responsible for assimilating this information and continuing the plan of care.[4] When transferring patients with HIV infection, providers should remember to include: current medications and drug allergies, the most recent CD4 cell count and HIV viral load, history of opportunistic infections, documentation of resistance viruses, hepatitis coinfection status, and an assessment of the social situation, as these are important for receiving team providers starting or altering ART. Disclosure of HIV status is a unique and dynamic piece of health information that concerns both patients and providers. During a transition, many patients are anxious or fearful of disclosing their HIV status to new providers and other patients.[16] Information on individuals who are aware or unaware of a patient's HIV infection should be communicated to prevent unwanted disclosure of HIV status. Healthcare organizations and providers should standardize the information necessary for transfer and leverage health information technology to optimize secure information exchange.

As patients move between healthcare settings, the delivery of care often changes. This may take the form of decreased support services and care integration, change in provider type and practice style, and the necessity of increased patient autonomy. Providers must be aware of these changes and prepare patients for the transition. This may involve incorporating a 'pretransfer visit,' where a receiving team member meets with the patient and the sending team prior to transfer; employing transitional care managers, advanced care nurses who care for the patient with the primary provider for a period of time posttransfer; or utilizing patient navigators.[6]


HIV-infected individuals are particularly vulnerable during periods of transition. The Dynamic Behavioral Model provides a framework for understating how changes in socioeconomic status, development stage, access to care, health information, and delivery of care influence health behaviors and outcomes. Providers, healthcare organizations, and payers should no longer view patients as static individuals confined to a particular health setting, but rather consider them as part a care continuum transferring between settings and providers with continuous management. Focusing on healthcare transitions may provide additional strategies for improving engagement in care and clinical outcomes.


  1. Ulett KB, Willig JH, Lin HY, Routman JS, Abroms S, Allison J, et al. The therapeutic implications of timely linkage and early retention in HIV care. AIDS Patient Care STDS 2009; 23:41–49.

  2. Gardner EM, McLees MP, Steiner JF, Del Rio C, Burman WJ. The spectrum of engagement in HIV care and its relevance to test-and-treat strateges for prevention of HIV infection. Clin Infect Dis 2011; 52:793–800.

  3. Centers for Disease Control and Prevention. Vital signs: HIV Prevention Through Care and Treatment - United States. MorbMortal Wkly Rep 2011; 60:1618–1623.

  4. Coleman EA, Fox PD, Workgroup obotHCM. One patient, many places: managing healthcare transitions, Part I: introduction, accountability, information for patients in transition. Ann Longterm Care 2004; 12:25–32.

  5. Reiss JG, Gibson RW, Walker LR. Healthcare transition: youth, family, and provider perspectives. Pediatrics 2005; 115:112–120.

  6. Coleman EA, Fox PD, Workgroup obotHCM. One patient, many places: managing healthcare transitions, Part I: introduction, accountability, information for patients in transition. Ann Longterm Care 2004; 12:14–16.

  7. Denning P, DiNenno E. Communities in crisis: is there a generalized HIV epidemic in impoverished urban areas of the United States? In: XVIII Interntional AIDS Conference Vienna, Austria; 2010.

  8. Baillargeon J, Giordano TP, Rich JD, Wu ZH, Wells K, Pollock BH, et al. Accessing antiretroviral therapy following release from prison. JAMA 2009; 301:848–857.

  9. Springer SA, Pesanti E, Hodges J, Macura T, Doros G, Altice FL. Effectiveness of antiretroviral therapy among HIV-infected prisoners: reincarceration and the lack of sustained benefit after release to the community. Clin Infect Dis 2004; 38:1754–1760.

  10. Wiener LS, Kohrt BA, Battles HB, Pao M. The HIV experience: youth identified barriers for transitioning from pediatric to adult care. J Pediatr Psychol 2011; 36:141–154.

  11. Yehia BR, Long JA, Stearns CR, French B, Tebas P, Frank I. Impact of transitioning from HIV clinical trials to routine medical care on clinical outcomes and patient perceptions. AIDS Care 2012; 24:769–777.

  12. Bodenheimer T. Coordinating care: a perilous journey through the healthcare system. N Engl J Med 2008; 358:1064–1071.

  13. Yehia BR, Mehta JM, Ciuffetelli D, Moore RD, Pham PA, Metlay JP, et al. Antiretroviral medication errors remain high but are quickly corrected among hospitalized HIV-infected adults. Clin Infect Dis 2012; 55:593–599.

  14. Kripalani S, LeFevre F, Phillips CO, Williams MV, Basaviah P,

  15. Baker DW. Deficits in communication and information transfer between hospital-based and primary care physicians: implications for patient safety and continuity of care. JAMA 2007; 297:831–841.

  16. Baillargeon J, Binswanger IA, Penn JV, Williams BA, Murray OJ. Psychiatric disorders and repeat incarcerations: the revolving prison door. Am J Psychiatry 2009; 166:103–109.

  17. Dowshen N, D'Angelo L. Healthcare transition for youth living with HIV/AIDS. Pediatrics 2011; 128:762–771.

  18. Dowshen N, Kuhns LM, Johnson A, Holoyda BJ, Garofalo R. Improving adherence to antiretroviral therapy for youth living with HIV/AIDS: a pilot study using personalized, interactive, daily text message reminders. J Med Internet Res 2012; 14:e51.

  19. Ginde AA, Lowe RA, Wiler JL. Health insurance status change and emergency department use among US adults. Arch Int Med 2012; 172:642–647.

  20. Bradford JB, Coleman S, Cunningham W. HIV System Navigation: an emerging model to improve HIV care access. AIDS Patient Care STDs 2007; 21 (Suppl 1):S49–S58.

  21. Fair CD, Sullivan K, Gatto A. Best practices in transitioning youth with HIV: perspectives of pediatric and adult infectious disease care providers. Psychol Health Med 2010; 15:515–527.

B.R.Y. developed the concept and drafted the manuscript. S.K. drafted the manuscript and provided critical revisions. I.F. provided critical revisions, administrative support, and study supervision.
This work was support, in part, by the Penn Center for AIDS Research, P30 AI 045008. B.R.Y. was supported by the National Institutes of Health (K23-MH097647-01A1).

AIDS. 2013;27(10):1529-1533. © 2013 Lippincott Williams & Wilkins


Black Market for HIV Antiretroviral Drugs Booming

Medscape Medical News > Conference News

Neil Canavan

Jul 10, 2013

KUALA LUMPUR, Malaysia — A disturbing number of men with legal access to antiretroviral medications are selling their prescriptions on the black market, according to new research.

These diverted medications mean an increase in the ongoing risk for HIV transmission and treatment failure because of resistance to therapy in those who become infected.

"We started receiving law enforcement reports about drug diversions around 5 years ago from major cities in the United States," said Steven Kurtz, PhD, from the Center for Applied Research on Substance Use and Health Disparities in Coral Gables, Florida. "It quickly became clear that street markets had developed for antiretroviral medications."

A previous study looking at this problem in impoverished men found a diversion rate as high as 20%. What Dr. Kurtz and his team set out to establish in their investigation was the extent of diversion practices in men who have sex with men.

Dr. Kurtz presented the research here at the 7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention.

The teams used the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) drug database to establish the prevalence of diversion. The system collects information from 300 law enforcement jurisdictions in the United States on sources of diversion such as undercover street purchases, arrests for distribution, and hospital and pharmacy theft.

It quickly became clear that street markets had developed for antiretroviral medications.

The RADARS data showed that 1518 cases of diversion had been investigated in 7 geographically diverse jurisdictions over 39 calendar quarters.

Dr. Kurtz and his team used this information to develop a survey about medical care, treatment, and adherence and diversion. It was completed by 515 men.

Of the 46.4% of respondents who were infected with HIV, 91.6% were receiving medical care. Nearly 80% of these men were prescribed much-needed antiretrovirals, yet 27.5% reported selling or trading their medications at some point, and 19.0% reported doing so in the previous year.

The respondents reported diverting their medications to share or trade with friends, to acquire money or illicit drugs, or to get rid of unused medications. Not surprisingly, antiretroviral diverters were more likely to be dependent on substances than nondiverters (74.5% vs 58.7%; P = .046), and more diverters reported recently trading sex for money or drugs (60.8% vs 32.6%).

Who is buying these drugs?

The demand for antiretrovirals increased with their recent approval for pre-exposure prophylaxis.

Party Packs Called MTV

"We've known from the literature and anecdotally that tenofovir, specifically, has been used for pre-exposure prophylaxis since at least 2009," Dr. Kurtz explained. It was even being distributed in clubs in Miami and other cities as a party pack called MTV, which consists of methamphetamine, emtricitabine plus tenofovir (Truvada), and sildenafil (Viagra). "That was a strong signal about what was going on."

"Frankly, we don't know who the purchasers are. Pill brokers are likely a big part of it, going in the back door of pharmacies, and recirculation. We need studies now to look at the demand side," he said.

"There's been a big black market in South Florida for many years," said Michael Weinstein, president of the AIDS Healthcare Foundation. "First off, Miami is the capital of Latin America. If the drugs are not available back home, you go to Miami. However, that's changed over time as treatment has become more common in poorer countries, so the incentive is now somewhat less."

Another market is individuals who are undocumented, explained Weinstein. "Usually, if you need to reduce the expense of your medications, you go to a government-sponsored clinic, but that requires providing some kind of information about yourself. Even though places like the Ryan White Program do cover undocumented patients, there are many who fear engagement with a government-run or any other type of formal facility."

Weinstein said that Gilead, the maker of Truvada, is somewhat complicit in the creation of the black market by aggressively promoting a product that, he believes, should not have been approved as a preventive measure in the first place.

"The whole premise of pre-exposure prophylaxis is dangerous and unwarranted based on study results. In the real world, pre-exposure prophylaxis relies on adherence, which in my opinion cannot be accomplished. People who already have the virus are often noncompliant. What you're going to wind up with is more infections and more resistance."

Dr. Kurtz and Mr. Weinstein have disclosed no relevant financial relationships.

The 7th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention: Abstract MOPE133. Presented July 1, 2013.


Quest Diagnostics Partners with CDC to Improve Hepatitis C Public Health Research to Promote Early Detection and Medical Intervention


Collaboration aims to improve health outcomes for the estimated 3.2 million Americans infected with hepatitis C

Jul 10, 2013

MADISON, N.J., July 10, 2013 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, today announced a collaboration with the U.S. Centers for Disease Control and Prevention (CDC) to improve public health analysis of hepatitis C screening, diagnosis and treatment, based on analysis of the company's national hepatitis C virus diagnostic information.

The collaboration aims to enhance screening, diagnosis and medical intervention for the approximately 3.2 million Americans infected with hepatitis C, promoting favorable health outcomes. The organizations will primarily focus on individuals born during 1945 through 1965. Individuals in this "baby boomer" generation are five times more likely than other adults to be infected, and one-time testing, as recommended by the CDC in 2012, could prevent more than 120,000 deaths in this age group.

In June 2013, the U.S. Preventive Services Task Force recommended one-time hepatitis C screening for all adults born between 1945 and 1965.

"Deaths from hepatitis C infection have nearly doubled over the past decade to now more than 15,000 a year.  Early detection and treatment of hepatitis C saves lives, but most people who are infected don't know it or are not being effectively treated," said Jay Wohlgemuth, M.D., senior vice president, science and innovation, Quest Diagnostics. "Our collaboration with the CDC underscores the importance of using diagnostic information to derive useful insights enabling effective prevention, detection and management programs for diseases with a significant impact on public health."

Under an agreement, medical experts, scientists and health informatics experts from Quest Diagnostics and the CDC's Division of Viral Hepatitis will share access to de-identified hepatitis C test results, in a HIPAA compliant manner, from the Quest Diagnostics Health Trends™ national clinical laboratory database, which represents every state and the District of Columbia. The de-identified data, with names and personally identifying information removed, will include results of screening and confirmatory diagnostic tests as well as genotyping and viral load tests used by clinicians to manage treatment. 

Data will be evaluated to identify and track epidemiological trends in hepatitis C virus infection, testing and treatment, and evaluate how those trends differ based on gender, age, geography and clinical management.  The organizations may jointly publish results of their research, such as in peer reviewed publications and scientific conferences.

"With 3 million Americans living with hepatitis C and up to 3 out of 4 who don't know they are infected, increased testing is critical to ensure that those who are infected receive life-saving care and treatment," said John W. Ward, M.D., director of CDC's Division of Viral Hepatitis. "Because these individuals are at serious risk for liver cancer, disease and death, I am excited about this innovative collaboration with Quest Diagnostics and believe it will help improve our understanding of how people access hepatitis C testing and care across the nation."

"This collaboration is an important step forward to producing actionable insights to aid public and clinical disease detection and management of hepatitis C," said Rick Pesano, M.D., Ph.D., medical director, infectious diseases. "Working with the CDC, Quest Diagnostics will lead the way for other providers to improve diagnosis and management of this disease, which in turn will help more people lead healthier lives."

Hepatitis C virus infection is the most common chronic bloodborne infection in the United States. The disease can cause liver damage and cancer and is a leading cause of liver transplants. Hepatitis C often does not manifest symptoms for decades. Early diagnosis, through laboratory blood tests, and treatment can help prevent liver damage, cirrhosis, liver cancer and death.

Quest Diagnostics provides comprehensive diagnostic information services for hepatitis C, including genotyping, risk stratifying and viral load testing, to aid the diagnosis, treatment, and monitoring of hepatitis C virus infection and disease.

About Quest Diagnostics Health Trends™ Reports
Quest Diagnostics Health Trends™ Reports provide insights into critical health issues, based on diagnostics data, affecting large numbers of Americans. The reports identify trends in disease and wellness based on analysis of de-identified test data from Quest Diagnostics, which maintains the largest private clinical laboratory database in the United States. Quest Diagnostics Health Trends™ Reports are published in peer-reviewed medical journals, at medical conferences and by the company as a public service. Previous reports have focused on prescription medication misuse, allergies and asthma, cardiovascular disease, chronic kidney disease, diabetes, heart disease, influenza, pregnancy, rotavirus, sexually transmitted infections and wellness. Visit QuestDiagnostics.com/HealthTrends.

About Quest Diagnostics
Quest Diagnostics is the world's leading provider of diagnostic information services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic information services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at QuestDiagnostics.com. Follow us at Facebook.com/QuestDiagnostics and Twitter.com/QuestDX.

Quest, Quest Diagnostics, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third-party marks are the property of their respective owners. 

Quest Diagnostics Contacts:
Wendy Bost (Media): 973-520-2800
Dan Haemmerle (Investors): 973-520-2900

SOURCE Quest Diagnostics Incorporated


Randomized Controlled Trial of Danoprevir Plus Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients with HCV Genotype 1 Infection


Article in Press

P. Marcellin, C. Cooper, L. Balart, D. Larrey, T. Box. E. Yoshida, E. Lawitz, P. Buggisch, P. Ferenci, M. Weltman, E. Labriola,Tompkins, S. Le, Pogam, I. Nájera, D. Thomas, G. Hoope,N.S. Shulman, Y. Zhang, M.T. Navarro, C.Y. Lim, M. Brunda, N.A. Terrault, E.S. Yetzer

Received 3 January 2013; received in revised form 20 June 2013; accepted 20 June 2013. published online 28 June 2013.

Accepted Manuscript



& Aims: The combination of an HCV protease inhibitor, peginterferon, and ribavirin is the standard of care for patients with HCV genotype 1 infection. We report the efficacy and safety of response-guided therapy with danoprevir (a potent second-generation protease inhibitor), peginterferon alfa-2a (40 KD), and ribavirin in these patients.


Treatment-naive patients (n=237) were randomly assigned to groups given 12 wks of danoprevir (300 mg every 8 h; 600 mg every 12 h, and 900 mg every 12 h) or placebo plus peginterferon alfa-2a and ribavirin, followed by peginterferon alfa-2a and ribavirin. Patients given danoprevir who had an extended rapid virologic response (eRVR4–20: HCV RNA <15 IU/mL during wks 4–20) stopped therapy at wk 24; those without an eRVR4–20 continued therapy to 48 wks. Patients who were given placebo received 48 wks of peginterferon alfa-2a and ribavirin. The primary efficacy endpoint was sustained virologic response (SVR: HCV RNA <15 IU/mL after 24 wks without treatment).


Rates of SVR were higher among patients given danoprevir 300 mg (68%), 600 mg (85%), and 900 mg (76%) than placebo (42%) (95% confidence interval [CI], 26%–59%). Seventy-nine percent of patients given danoprevir 600 mg had an eRVR4–20; among these, 96% had an SVR. Serious adverse events were reported in 7%–8% of patients given danoprevir and 19% given placebo. Four patients given danoprevir (1 patient in the 600 mg group and 3 in the 900 mg group) had reversible, grade 4 increases in alanine aminotransferase (ALT); this led to early discontinuation of the 900 mg arm of the study.


The combination of danoprevir, peginterferon alfa-2a, and ribavirin leads to high rates of SVR in patients with HCV genotype 1 infection, but high doses of danoprevir can lead to grade 4 increases in ALT. Studies of lower doses of danoprevir with ritonavir, to reduce overall danoprevir exposure while maintaining potent antiviral activity, are underway. Clinicaltrials.gov number, NCT00963885.

Keywords: danoprevir (RG7227), hepatitis C virus, sustained virologic response, response-guided therapy


Marijuana not associated with liver disease progression in HIV/HCV coinfection

Provided by Healio

Brunet L. Clin Infect Dis. 2013;doi:10.1093/cid/cit378.

July 10, 2013

Smoking marijuana did not lead to liver disease progression among people coinfected with HIV and hepatitis C, researchers from McGill University have found.

“The literature regarding the effects of cannabis on liver diseases is conflicting,” the researchers wrote in Clinical Infectious Diseases. “Cell culture and animal model studies support that cannabinoids could have a therapeutic effect on liver injury and fibrosis progression. However, three cross-sectional studies in patients with chronic HCV suggest that daily cannabis use is associated with fibrosis and steatosis.”

The study included 690 patients who were positive for HCV but did not have significant fibrosis or end-stage liver disease (ESLD). The patients were part of the Canadian Coinfection Cohort and visited their providers every 6 months, contributing to 1,875.3 person-years of follow-up, with a median follow-up time of 2.7 years. At each visit, they reported their marijuana use, including how often they smoked and the amount they consumed.

At baseline, 53% of the patients reported smoking marijuana in the past 6 months. The median consumption was seven joints per week, and 40% of the patients smoked daily. Among the patients, 19.1% developed liver fibrosis and 14.8% developed cirrhosis, according to APRI score. Eleven patients developed ESLD and eight patients developed clinical cirrhosis.

Multivariate analysis showed that marijuana use was not associated with fibrosis or cirrhosis as measured by APRI score. Smoking marijuana did accelerate progression to clinical cirrhosis (HR=1.33 per 10 joints/week; 95% CI, 1.09-1.62). Marijuana smoking was also associated with an increased risk of clinical cirrhosis and ESLD combined (HR=1.13; 95% CI, 1.01-1.28). However, if the exposure lagged 6 to 12 months before diagnosis, they were no longer associated (HR=1.10; 95% CI, .95-1.26).

“A causal association is unlikely: hazard ratios were weak and most importantly were attenuated when accounting for temporality in the exposure-disease relationship and there was no dose-response relationship,” the researchers wrote. “It is likely that previous studies have been biased by reverse causality as patients use more marijuana to relieve symptoms as liver disease progresses.”

Disclosure: The researchers report no relevant financial disclosures.


Around 10m suffering from hepatitis in Pakistan: experts

Obaid Abrar Khan
Tuesday, July 09, 2013
From Print Edition

Rawalpindi: A table talk on ‘Importance of hepatitis awareness, prevention and treatment’ was organised by the Mir Khalil-ur-Rehman Memorial Society (MKRMS) with the collaboration of Roche Pharma here on Monday.

Minister of State for National Health Services, Regulations and Coordination Saira Afzal Tarar was the chief guest on the occasion. Khyber-Pakhtunkhwa Minister for Health Shoukat Ali Yousafzai attended the talk as guest of honour. Professor of Medicine at Rawalpindi Medical College Professor Dr. Shoaib Shafi and Professor Dr. Muzzaffar Lateef Gill attended the event as keynote speakers. Senior Editor and Mir Khalil-ur-Rehman Memorial Society Chairman Wasif Nagi was the host.

The participants of the talk said that around 10 million citizens of Pakistan were suffering from hepatitis. A large number of residents of Hafizabad and Mandi Bahauddin were suffering from this silent killer.

Minister of State for National Health Services, Regulations and Coordination Saira Afzal Tarar, in her address, said that the federal government has been working on the National Health Policy. She said that a meeting would be called in this regard by the end of this month. “We have constituted a task force on national level to make the National Health Policy,” she added.

She said that after taking charge she found corruption and mismanagement in all departments. She said that the list of corrupt and non-professional officials has been sent to Prime Minister’s Office. “I am searching for eligible candidates for key posts to make the health department active and effective,” she added.

Talking about hepatitis, Saira Afzal Tarar said that there was a need to spread awareness among the public about preventive measures and to fight against this silent killer. She said that it was the responsibility of qualified doctors to come forward and give suggestions to the government and fight against hepatitis.

Shoukat Ali Yousafzai said that around 480,000 patients were suffering from Hepatitis-B and around 1,680,000 were suffering from Hepatitis-C in Khyber-Pakhtunkhwa. “A survey has found that most patients of hepatitis are from Peshawar,” he added.

He said that the Khyber-Pakhtunkhwa government has been giving special attention to health and they have distributed equipment in all districts for free testing of hepatitis. He said that there was a need to create awareness among the public and to tell them to keep the environment clean and protect themselves from this silent killer.

Dr. Shoaib Shafi said: “We are fighting against terrorism. We have to fight against hepatitis which is more dangerous.” He said that around 10 million citizens of Pakistan were suffering from hepatitis. Most of the hepatitis patients were from Hafizabad and Mandi Bahauddin. As many as 8.3% of patients were from Rawalpindi Division and 13.5% of women were suffering from this disease, which was alarming situation for the government. “Around 1,100 patients are under treatment at the Liver Centre of Benazir Bhutto Hospital, Rawalpindi,” he added.

Talking about problems in treatment, Dr. Shoaib Shafi said that there was no facility for hepatitis test in government hospitals, whereas in private laboratories this test was expensive and out of the reach of poor people. The government should make arrangements to give this facility in government hospitals free of cost and it also set up liver transplant centres in public hospitals.

About the symptoms of hepatitis, Dr. Shoaib Shafi said that most patients were diagnosed at the last stage of the disease because of lack of awareness. “This disease spreads due to filthy water, used syringes and infected blood transfusion,” he said.

Professor Dr. Muzaffar Lateef Gill (Sitara-i-Imtiaz) said: “Unfortunately, we are not giving quality treatment to patients of hepatitis in government hospitals. We have made two standards of treatment — one is for the poor, which is not quality treatment, and the other one is for wealthy people, which is very effective.”

He said that although government was providing free treatment of hepatitis in government hospitals but the efficacy of injections used was not so good. “These injections treat only 60% of patients and 25% patients get the virus back.” “The government should give quality treatment at low cost,” he said and added that doctors should also play their role and think before giving medicines to the patients of hepatitis.

Dr. Muzaffar Lateef Gill said that different pharmaceutical companies were also taking advantage and marketing low quality injections from different countries. The government should take notice of such medicines, which are banned all over the world but still available in Pakistan, he concluded.