Tuesday, September 26, 2017

California Scrambles To Contain ‘Unprecedented’ Hepatitis A Outbreaks

California Scrambles To Contain ‘Unprecedented’ Hepatitis A Outbreaks
By Stephanie O'Neill September 26, 2017

Health officials in California are struggling to contain fierce outbreaks of hepatitis A among homeless people and drug abusers in three counties, including San Diego, where at least 17 people have died.

Hundreds more have become ill and been hospitalized, mostly in the San Diego area, often not far from tourist destinations. The disease also has cropped up farther north in Los Angeles and Santa Cruz counties. Poor access to restrooms and sinks in homeless encampments is largely to blame.

Public health officials say the crisis has caught them off guard because it’s rare for the disease to spread so rampantly when it isn’t tied to a common source, such as a tainted food product. Meanwhile, as cases mount with no end in sight, critics fault authorities’ response as lethargic.

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Three or more cups of coffee daily halves mortality risk in patients with both HIV and HCV

Of Interest
The latest scoop on the health benefits of coffee
September 25, 2017 Harvard Health Blog
Robert H. Shmerling, MD, Faculty Editor, Harvard Health Publications
Over the last several decades, coffee has been among the most heavily studied dietary components. And the news is mostly good. Moderate coffee consumption (three to four cups per day) has been linked with longer lifespan.
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Three or more cups of coffee daily halves mortality risk in patients with both HIV and HCV
September 25, 2017
Novel five-year study highlights importance of behaviors such as coffee drinking and not smoking on health and survival of HIV-infected patients, report investigators in the Journal of Hepatology

Amsterdam, The Netherlands, September 25, 2017 - Patients infected by both human immunodeficiency virus (HIV) and hepatitis C virus (HCV) are at specific risk of end-stage liver disease and greater risk of cardiovascular diseases and cancer. In addition, HIV infection accelerates the progression of chronic hepatitis C to fibrosis and development of cirrhosis and end-stage liver disease. In these HIV-HCV co-infected patients, drinking at least three cups of coffee each day halved the risk of all-cause mortality according to a new study published in the Journal of Hepatology.

This study is the first to investigate the relationship between coffee consumption and the risk of all-cause mortality in HIV-HCV co-infected patients. "This is a very exciting time for HCV research as a cure that can eradicate the virus is now available for all patients," explained lead investigator Dominique Salmon-Céron, MD, PhD, of the Service des Maladies Infectieuses et Tropicales, Hôpital Cochin, and Université Paris Descartes, Paris, France. "However, even when cured of HCV, patients co-infected with HIV have a higher risk of death with respect to the general population, due to an accelerated aging process that may result from cancer, complications related to diabetes and to liver disease, and from cardiovascular events."

Coffee is known to have anti-inflammatory and liver-protective properties. In the general population, drinking three or more cups of coffee a day has been found to be associated with a 14% reduction in the risk of all-cause mortality. This is probably due to the properties of polyphenols contained in coffee that can protect the liver and also reduce inflammation.

Investigators used data from a five-year follow-up of 1,028 HIV-HCV co-infected patients enrolled in the French national ANRS CO13-HEPAVIH cohort. ANRS CO13-HEPAVIH is an ongoing French nationwide prospective cohort of HIV-HCV co-infected patients that collects both medical and psychosocial/behavioral data over time via annual self-administered questionnaires.

At enrolment, one in four patients reported drinking at least three cups of coffee daily. Over the five years, 77 deaths occurred, almost half attributable to hepatitis C. However, the mortality risk was 80% lower in those who were cured of (i.e. who "cleared") hepatitis C thanks to treatment.

Further analysis showed that drinking at least three cups of coffee daily was associated with a 50% reduction in mortality risk even after taking into account HCV clearance, HIV- and HCV-related factors, and other sociobehavioral factors, such as having a steady partner and not smoking. Healthy behavior change should be promoted by physicians following HCV clearance.

This research highlights the importance of behaviors - coffee consumption and not smoking in particular - on reduced mortality risk. These results can help promote behavioral changes in HIV-HCV patients, which in turn can result in improved survival. With respect to coffee consumption, individuals who do not drink coffee because of caffeine can still benefit from the comparable anti-inflammatory effects of decaffeinated coffee.

First author Maria Patrizia Carrieri, PhD, of the HEPAVIH Study Group, Faculté de Médecine, Aix Marseille University, INSERM, IRD, SESSTIM, Marseilles, France, observed that coffee consumption provides more protective effects on mortality in the HIV-HCV population than in the general population.

"The results of our study show that while curing HCV is fundamental, it must be complemented by behavioral changes if we are to improve health and survival in HIV-infected patients whether or not they cleared HCV. "I think we need to better monitor coffee consumption, together with other behaviors, such as alcohol use, smoking, physical activity, and to propose interventions to our patients which facilitate healthy behaviors even after HCV clearance. We also suggest that those patients who cannot tolerate a high intake of caffeine should consider drinking a few cups of decaffeinated coffee a day," commented Dr. Salmon-Céron. "Accordingly, I believe that the benefits of coffee extracts and supplementing dietary intake with other anti-inflammatory compounds need to be evaluated in HIV-HCV patients."

Hepatitis C cross-genotype immunity and implications for vaccine development

Hepatitis C cross-genotype immunity and implications for vaccine development
Nazrul Islam, Mel Krajden, Jean Shoveller, Paul Gustafson, Mark Gilbert, Jason Wong, Mark W. Tyndall, Naveed Zafar Janjua & The BC-HTC Team
Published online:

  • Scientific Reports 7, Article number: 12326 (2017)
  • doi:10.1038/s41598-017-10190-8

  • Abstract
    While about a quarter of individuals clear their primary hepatitis C (HCV) infections spontaneously, clearance (spontaneous or treatment-induced) does not confer sterilizing immunity against a future infection. Since successful treatment does not prevent future infections either, an effective vaccine is highly desirable in preventing HCV (re)infection. However, development of an effective vaccine has been complicated by the diversity of HCV genotypes, and complexities in HCV immunological responses. Smaller studies on humans and chimpanzees reported seemingly opposing results regarding cross-neutralizing antibodies. We report a lack of cross-genotype immunity in the largest cohort of people to date. In the adjusted Cox proportional hazards model, reinfection with a heterologous HCV genotype (adjusted Hazard Ratio [aHR]: 0.45, 95% CI: 0.25–0.84) was associated with a 55% lower likelihood of re-clearance. Among those who cleared their first infection spontaneously, the likelihood of re-clearance was 49% lower (aHR: 0.51, 95% CI: 0.27–0.94) when reinfected with a heterologous HCV genotype. These findings indicate that immunity against a particular HCV genotype does not offer expanded immunity to protect against subsequent infections with a different HCV genotype. A prophylactic HCV vaccine boosted with multiple HCV genotype may offer a broader and more effective protection.

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    Most patients with HCV genotypes 2, 4, 5, 6 achieve SVR with Mavyret

    Most patients with HCV genotypes 2, 4, 5, 6 achieve SVR with Mavyret
    Asselah T, et al. Clin Gastroenterol Hepatol. 2017;doi:10.1016/j.cgh.2017.09.027.
    September 26, 2017
    Most patients with hepatitis C genotype 2, 4, 5 or 6 who received Mavyret for 8 weeks achieved sustained virologic response with a high safety profile, according to results from three phase 3 studies. The rate of virologic failure was less than 1%.

    Health News & Clickbait Headlines

    Health News & Clickbait Headlines
    News articles about health is a hot topic for media outlets, its profitable, its a great marketing tool, and its full of clickbait headlines. The possibilities are endless, we all remember this recent headline; "Hepatitis ‘wonder drug’ may be clinically ineffective, say experts," one that may have influenced patients from seeking HCV testing or treatment, a concern shared by advocates, clinicians, scientists and health organizations alike. 

    Recently, HealthNewsReview, a site dedicated to the quality of online health information, published an article written by Alan Cassels about why we find these clickable headlines so tempting, with a look at related health news clickbait trends.

    Yes, a listicle: 10 times we couldn’t resist writing about health news clickbait
    As a self-avowed beer snob, I would be the kind of audience that would surely be lured by the health clickbait proclaiming “Beer hops may protect against liver disease.
    After all, when you find something that reinforces your questionable habits, how can you not click on it? That is the essence of clickbait–to write a headline that’s irresistible, with the goal of driving up page views and advertising money.
    Read the article, here....

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    The mission of HealthNewsReview.org is to improve the public dialogue about health care by helping consumers critically analyze claims about health care interventions and by promoting the principles of shared decision-making reinforced by accurate, balanced and complete information about the tradeoffs involved in health care decisions. HealthNewsReview.org evaluates health care journalism, advertising, marketing, public relations and other messages that may influence consumers and provides criteria that consumers can use to evaluate these messages themselves. Improving the quality and flow of health care news and information to consumers can be a significant step towards meaningful health care reform.

    Behind the Headlines
    Each day NHS Choices team selects health stories that are making headlines. These, along with the scientific articles behind the stories, are sent to Bazian, a leading provider of evidence-based healthcare information. Bazian's clinicians and scientists analyse the research and produce impartial evidence-based assessments, which are edited and published by NHS Choices.

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    MD Whistleblower presents vignettes and commentaries on the medical profession. We peek 'behind the medical curtain' and deliver candor and controversy in every post.

    Healthfinder.gov draws on more than 1,600 government and non-profit organizations to point you to current information. The site — a product of the Office of Disease Prevention and Health Promotion in the Department of Health and Human Services (HHS) — also offers consumer health guides, recent health news by topic, and a directory of health-related organizations.

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    Monday, September 25, 2017

    People of Mexican decent in US have more liver cancer risk factors than those living in Mexico

    People of Mexican decent in US have more liver cancer risk factors than those living in Mexico

    Individuals of Mexican descent who reside in the US have more risk factors for liver cancer than those who live in Mexico

    American Association for Cancer Research

    ATLANTA -- Mexican-Americans living in the United States demonstrated more risk factors for liver cancer than their counterparts in Mexico, according to results of a study presented at the 10th AACR Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, held here Sept. 25-28.

    "Liver cancer incidence and mortality have been on the rise in the United States, despite a steady decline in overall cancer incidence and mortality over the past 15 years," said the study's lead author, Yvonne N. Flores, PhD, associate professor at the UCLA Cancer Prevention and Control Research Center, Fielding School of Public Health and Jonsson Comprehensive Cancer Center, and the UCLA Kaiser Permanente Center for Health Equity. "Chronic liver disease, which can lead to liver cancer, is a leading cause of mortality in Mexico and among people of Mexican descent living in the United States. We wanted to compare the prevalence of risk factors in these two groups."

    Flores and colleagues examined data for Mexican-Americans living in the U.S. from the 1999-2014 National Health and Nutrition Examination Survey; and data from Mexican residents from the Health Worker Cohort Study, conducted from 2004 to 2006, with follow-up conducted from 2011 to 2013. The total study sample included 13,798 individuals -- 9,485 Mexicans residing in Mexico; 2,324 U.S.-born Mexican-Americans living in the United States; and 1,989 Mexican-Americans who were born in Mexico and now live in the United States.

    They evaluated the participants for the primary known risk factors for liver disease, including infection with hepatitis B or C virus, metabolic syndrome, high total cholesterol, diabetes, overall obesity, abdominal obesity, and heavy alcohol use.

    After controlling for age, marital status, and education level, the results showed that Mexican-American men and women were more likely to be obese (overall and abdominal obesity), diabetic, and heavy drinkers than those born and living in Mexico.

    The results were reversed for hepatitis B or C infection. The study showed that Mexican-American men and women were less likely to have hepatitis B or C infections than their counterparts in Mexico.

    Flores said it is important for health care practitioners to be aware of the numerous risk factors that may lead to liver disease in their patients of Mexican descent. "Having a combination of risk factors for liver disease, such as obesity and excessive drinking, or diabetes and chronic hepatitis C infection, has been shown to increase risk of liver cancer," she said. "More studies are needed to evaluate how the accumulation of specific risk factors may be contributing the increased risk of chronic liver disease in Mexican-Americans."

    Flores added that other ethnic minority groups, including Asians, other Latinos, and African-Americans, also face liver cancer incidence and mortality rates significantly higher than the rates for non-Hispanic whites, and a deeper understanding of liver cancer risk factors could help inform prevention efforts.

    "We need more comprehensive and precise exposure assessment approaches that can improve the prevention, early detection, and treatment of chronic liver disease, in order to delay or prevent the progression to liver cancer," she said.

    Flores cautioned that further research would be necessary to determine whether the results of this study are applicable to all Mexicans and Mexican-Americans. She said the study's primary limitation is that the data from Mexico came from the Health Worker Cohort Study, so the participants may have been younger and more educated than the general public. She said the researchers consulted broader Mexican population studies and found similar overall trends.

    The study was funded by grants from the Programa de Investigación en Migración y Salud, the Instituto Mexicano del Seguro Social, and the Consejo Nacional de Ciencia y Tecnologia. The authors declare no conflicts of interest.

    Abstract: A34
    Risk factors for liver disease/cancer among adults of Mexican descent in the United States and Mexico. Yvonne N. Flores1, Zuo-Feng Zhang2, Roshan Bastani1, Mei Leng3, Catherine M. Crespi4, Paula Ramirez5, Heather A. Stevens6, Jorge Salmerón7. 1UCLA Department of Health Policy and Management, Fielding School of Public Health, Los Angeles, California, 2UCLA Department of Epidemiology, Fielding School of Public Health, Los Angeles, California, 3UCLA Division of General Internal Medicine and Health Services Research, Los Angeles, California, 4UCLA Department of Biostatistics, Fielding School of Public Health, Los Angeles, CA, 5Unidad de Investigación Epidemiológica y en Servicios de Salud, Morelos, IMSS, Cuernavaca, Morelos, Mexico, 6University of Washington, School of Medicine, Seattle, WA, 7Unidad Académica en Investigación Epidemiológica, UNAM, Ciudad De Mexico, DF, Mexico.

    Background: Latinos in the United States (US) have disproportionately higher rates of chronic liver disease (CLD). Since 2002, CLD has consistently been the sixth leading cause of overall mortality for Latinos, and the third cause of death among Latino males, ages 55-64. Latino men and women are twice as likely to have CLD and are 1.7 and 1.8 times more likely to die from liver cancer, respectively, than non-Hispanic whites (whites). The frequency of earlier stage liver disease, such as steatohepatitis, is also higher among Latinos (45%), than among whites (33%), or Blacks (24%). In Mexico, cirrhosis and other forms of CLD were the fifth leading cause of general mortality in 2015, and the third among males between the ages of 45 and 65 years. By 2050, an estimated 90% of cases of CLD in Mexico will be attributable to obesity and excessive alcohol consumption, as compared to other populations that have high rates of CLD due to infection with hepatitis B (HBV) or hepatitis C (HCV).

    Although infection with HBV or HCV and heavy alcohol use are well known risk factors for CLD and liver cancer, up to 50% of cases do not present these risk factors. Other risk factors for CLD include obesity and diabetes, and the proposed mechanism is through the development of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). NAFLD is found in 80-90% of obese adults, 30-50% of diabetics, and 90% of patients with hyperlipidemia. In the US, the prevalence of NAFLD and NASH is highest among Latinos, followed by whites and Blacks. Rates of obesity are also higher among Latinos (42.5%) than whites (34.5%) in the US. In 2012, approximately 69% of men and 73% of women in Mexico were overweight or obese, and these numbers are predicted to rise to 88% and 91%, respectively by 2050.

    The objective of this study was to compare the prevalence of risk factors for liver disease/cancer in a representative sample of Mexican-Americans who were born in the US or Mexico, to a sample of adults who reside in Mexico. We hypothesized that Mexican-Americans in the US would be at greater risk for CLD than their counterparts in Mexico. This hypothesis is based on studies suggesting that immigrant Mexican-Americans have better health outcomes than more acculturated, US-born Mexican-Americans.

    Methods: Data for Mexican-Americans in the US was obtained from the 1999-2014 National Health and Nutrition Examination Survey (NHANES), a cross-sectional, representative, examination survey of the total civilian non-institutionalized population. The NHANES sample was restricted to Mexican-American participants who were 20 years and older, born in the US or Mexico, not pregnant or breastfeeding, with medical insurance. The final NHANES sample consisted of 2,097 males and 2,177 females with complete questionnaire and laboratory data.

    The data in Mexico came from the Heath Worker Cohort Study (HWCS), a longitudinal study of workers and their immediate family members from two large health care institutions in Cuernavaca, Mexico: the Mexican Institute of Social Security (IMSS) and the National Institute of Public Health (INSP). Briefly, the HWCS collects information using physical examinations, self-reported questionnaires, and laboratory tests, which are comparable to those used for the NHANES surveys. From 2004 to 2006 (Wave 1), approximately 9,000 health workers enrolled in the HWCS. During 2011 to 2013 (Wave 2), a total of 1,855 participants were followed-up. The final HWCS sample consisted of 3,010 men and 6,475 women 20 years and older who reside and were born in Mexico, with complete questionnaire and laboratory data. The total study sample of 13,798 individuals consisted of 9,485 Mexican subjects who currently reside in Mexico, 2,324 US-born Mexican-Americans who live in the US, and 1,989 Mexican-Americans who were born in Mexico and now live in the US.

    The following known risk factors for liver disease/cancer were evaluated: elevated aminotransferase levels (elevated ALT was defined as >40 IU/L for men and women; elevated AST was defined as >40 IU/L for men and women), infection with HBV or HCV, metabolic syndrome, high total cholesterol, diabetes, obesity, abdominal obesity, and heavy alcohol use. The main independent variables for this study classified individuals by country of residence (i.e., Mexico versus the US) and place of birth (i.e., US-born versus Mexico- born). The HWCS participants represent Mexicans who were born and currently live in Mexico. Individuals from the NHANES sample were further classified by birthplace (US-born versus Mexico-born). The following three groups were compared: (1) HWCS (Mexico resident, Mexico-born), (2) NHANES (US resident, Mexico-born), and (3) NHANES (US resident, US-born). Other independent variables included age, sex, marital status, and education level. Regression analyses were used to investigate liver disease/cancer risk factors.

    Results: After controlling for age, marital status, and education level, the logistic regression results indicate that Mexico-born Mexican-American males were less likely to have HBV or HCV (OR 0.2, 95% CI 0.1-0.6) but were more likely to have high cholesterol (OR 1.4, 95% CI 1.1-1.8), than their counterparts in Mexico. US-born Mexican-American males were more likely to have metabolic syndrome (OR 1.4, 95% CI 1.1-1.9) and diabetes (OR 3.0, 95% CI 1.9-4.8), than males in Mexico. Mexican-American males were much more likely to be obese, diabetic, have abdominal obesity, or be heavy/binge drinkers, than Mexican males. The prevalence ratios and prevalence differences confirm the multivariate analyses findings and may provide more precise estimates of the increased risk of diabetes, obesity, abdominal obesity, and heavy/binge drinking observed among Mexico- and US-born Mexican-American males, as compared to males in Mexico. The probability of having any of the aforementioned risk factors is greater among US-born Mexican-Americans than among their Mexico-born counterparts.

    The adjusted multivariate results for females also indicate that Mexican-American females were significantly more likely to be obese, diabetic, have abdominal obesity, or be heavy/binge drinkers, than Mexican males. The prevalence ratios and prevalence differences mirror the multivariate analyses findings for the aforementioned risk factors, showing a greater risk among US-born as compared to Mexico-born Mexican-Americans. However, the prevalence ratio results indicate that Mexico- and US-born Mexican-American females are significantly less likely to be infected with HBV or HCV than females in Mexico.

    Conclusions: The results of this binational analysis indicate that Mexican-Americans in the US have more risk factors for liver disease/cancer than their counterparts in Mexico. These results can be used to design and implement more effective health promotion programs to address the specific factors that put Mexicans at higher risk of developing liver disease/cancer in both countries. This study adds to the relatively scarce literature on binational research, and provides preliminary data for future studies of migrant health in the US and Mexico. Other binational primary data collection projects with representative samples and comparable demographic, socioeconomic and health status measures are needed to further investigate the growing problem of liver disease/cancer among Mexicans in both countries.

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    Gilead's Sovaldi® (Sofosbuvir) Approved In China for Treatment of Chronic Hepatitis C

    China Food and Drug Administration Approves Gilead's Sovaldi® (Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Infection

    - Sovaldi-based Regimens Demonstrated High Rates of Sustained Virologic Response or Cure for Chinese Hepatitis C Infected Patients -

    FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 25, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China Food and Drug Administration (CFDA) has approved Sovaldi® (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.
    The approval of Sovaldi is supported by a Phase 3 study conducted in China, presented earlier this year at the Asian Pacific Association for the Study of the Liver (APASL) meeting. SVR12 (HCV RNA undetectable 12 weeks after completing therapy) rates for Chinese HCV patients with genotype 1, 2, 3 or 6 ranged from 92-100 percent. The study evaluated Sovaldi in combination with ribavirin (RBV) or pegylated interferon+ribavirin (PegIFN+RBV) across a range of difficult-to-cure patient populations, including treatment-experienced patients and those with compensated cirrhosis. In this study, the safety profiles of the regimens were consistent with the known side effects of pegylated interferon and/or ribavirin. The most common adverse events were hematological abnormalities and pyrexia.
    Professor Lai Wei, the principal investigator of Sovaldi’s Phase 3 study and former Chairman of the Chinese Society of Hepatology of the Chinese Medical Association said, “The approval of sofosbuvir in China provides more treatment options for Chinese HCV patients. The clinical trials in China and around the world provide evidence that the treatment is effective for multiple genotypes, which offers HCV patients in China a better chance at curing their disease.”
    HCV is the fourth-most commonly reported infectious disease in China, with approximately 10 million people infected. HCV genotypes 1, 2, 3 and 6 account for more than 96 percent of all cases. Less than one percent of HCV patients are currently treated, using interferon-based regimens that have lower efficacy, longer treatment duration and less favorable safety profiles than more recent regimens that contain direct-acting antiviral medicines.
    “With the approval of Sovaldi, there is now the potential opportunity to transform treatment for HCV patients in China,” said John F. Milligan, PhD, Gilead’s President and Chief Executive Officer. “Medicines are one part of the solution but, as we have seen in other countries around the world, there are many other challenges that impact diagnosis, linkage to care and treatment. Gilead is committed to working with the government and other stakeholders with the goal to help reduce the significant burden of HCV disease in China.”
    Sovaldi received marketing approval from the U.S. Food and Drug Administration (FDA) in 2013 and the European Commission in 2014. It is also approved for use in 79 countries including Australia, India, Indonesia, the Philippines, New Zealand, Canada, Egypt, Switzerland and Turkey.

    Sunday, September 24, 2017

    Sofosbuvir plus ribavirin treatment of HCV genotype 2: results of the real-world, clinical practice HCV-TARGET study

    Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study
    Tania M Welzel1, David R Nelson2, Giuseppe Morelli2, Adrian Di Bisceglie3, Rajender K Reddy4, Alexander Kuo5, Joseph K Lim6, Jama Darling7, Paul Pockros8, Joseph S Galati9, Lynn M Frazier10, Saleh Alqahtani11, Mark S Sulkowski11, Monika Vainorius7, Lucy Akushevich7, Michael W Fried7, Stefan Zeuzem1 for the HCV-TARGET Study Group

    Full Text

    In summary, in this large, international cohort study, the all-oral combination of SOF and RBV was safe and effective for treatment of HCV GT2. While response rates in patients without cirrhosis were high and comparable with those reported in clinical trials, the presence of lower albumin levels and liver cirrhosis was associated with lower SVR12 rates. Larger, randomised trials in patients with cirrhosis are required to determine the benefit of extended treatment durations of SOF and RBV in this patient group. Recent studies showed that combined SOF and valpatasvir (ASTRAL-1, ASTRAL-2) yielded SVR12 rates of up to 100% in patients with GT2 and cirrhosis, so that the combination of SOF and a GT2-active NS5A inhibitor for 12 weeks may be preferable to SOF and RBV for more than 12 weeks in patients with GT2 and liver cirrhosis.

    Objective Due to a high efficacy in clinical trials, sofosbuvir (SOF) and ribavirin (RBV) for 12 or 16 weeks is recommended for treatment of patients with HCV genotype (GT) 2 infection. We investigated safety and effectiveness of these regimens for GT2 in HCV-TARGET participants.

    Design HCV-TARGET, an international, prospective observational study evaluates clinical practice data on novel antiviral therapies at 44 academic and 17 community medical centres in North America and Europe. Clinical data were centrally abstracted from medical records. Selection of treatment regimen and duration was the investigator's choice. The primary efficacy outcome was sustained virological response 12 weeks after therapy (SVR12).

    Results Between December 2013 and April 2015, 321 patients completed 12 weeks (n=283) or 16 weeks (n=38) of treatment with SOF and RBV. Prior treatment experience and cirrhosis was more frequent among patients in the 16-week regimen compared with 12 weeks (52.6% vs 27.6% and 63.2% vs 21.9%, respectively). Overall, SVR12 was 88.2%. The SVR12 in patients without cirrhosis was 91.0% and 92.9% for 12 or 16 weeks of therapy, respectively. In patients with cirrhosis treated for 12 or 16 weeks, SVR12 was 79.0% and 83%. In the multivariate analysis, liver cirrhosis, lower serum albumin and RBV dose at baseline were significantly associated with SVR12. Common adverse events (AEs) included fatigue, anaemia, nausea, headache, insomnia, rash and flu-like symptoms. Discontinuation due to AEs occurred in 2.8%.

    Conclusions In this clinical practice setting, SOF and RBV was safe and effective for treatment of patients with HCV GT2 infection