Hepatitis C Treatment After Kidney Transplant May Extend Lives and Decrease Costs

MedicalResearch.com Interview with:

Mark H. Eckman, MD Posey Professor of Clinical Medicine Director, Division of General Internal Medicine Director, Center for Clinical Effectiveness University of Cincinnati Medical Center Cincinnati, OH

Dr. Eckman

Mark H. Eckman, MD
Posey Professor of Clinical Medicine
Director, Division of General Internal Medicine
Director, Center for Clinical Effectiveness
University of Cincinnati Medical Center
Cincinnati, OH 

MedicalResearch.com: What is the background for this study?

Response: People who are infected with hepatitis C virus and have kidney failure need a kidney transplant.

Recent studies have found that it is possible to transplant kidneys from donors who are infected with hepatitis C virus into patients who need a transplant and are already infected with the virus. In addition, drugs are available to cure most patients of hepatitis C virus, including those who have kidney failure. Infected patients who need a kidney transplant have 2 options. One option is to receive an infected kidney and then use drugs after the transplant to cure themselves and the transplanted kidney of the virus. Another option is to use the drugs first to get rid of the virus and then to receive a kidney from a donor who does not have hepatitis C virus infection.

For the more than 500,000 patients receiving dialysis for end-stage renal disease (ESRD), less than 4% receive kidney transplants. Because of the limited organ availability, hemodialysis is the final treatment for most patients with ESRD. Of the 10% or so of U.S. patients receiving dialysis who are infected with the hepatitis C virus (HCV), some are willing to accept HCV-infected kidneys, in part, because the wait times for such kidneys are shorter than those for HCV-uninfected kidneys. Because the yearly mortality rate for patients receiving hemodialysis is so high, between 4% and 16%, reducing the time to kidney transplant can have a dramatic effect on both survival and quality of life.

Because it may not be possible to do this type of research with actual people, we created a model that allowed us to estimate possible outcomes without using actual people.

The model was a computer program that combined the best available information to approximate what might happen to participants in a real-world clinical trial. Continue reading

Double-Edge Sword of Drug Epidemic

MedicalResearch.com Interview with:
Christine Marie Durand, M.D
.
Assistant Professor of Medicine
Johns Hopkins Medicine 

MedicalResearch.com: What is the background for this study

Response: Most Americans know that the United States faces an epidemic of deaths due to drug overdose.  And many are also aware that there is a critical shortage of organs available for transplant.  Perhaps less widely known is that today, more than 1 in every 8 deceased organ donors died from a drug overdose.  The objective of our study was to look at the outcomes of patients who received transplants with organs donated after an overdose.

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Most Baby Boomers Still Aren’t Screened For Hepatitis C

MedicalResearch.com Interview with:

In the United States, hepatitis A, hepatitis B and hepatitis C are the most common types, but also included are hepatitis D and E. CDC/ E.H. Cook, Jr.

Hepatitis Virions
CDC/ E.H. Cook, Jr.

Dr. Monica Kasting PhD first author
Dr. Anna Giuliano PhD
Susan. T. Vadaparampil, Ph.D., M.P.H.
Senior Member/Professor
Center for Infection Research in Cancer
H. Lee Moffitt Cancer Center, Tampa,
Florida.Department of Cancer Epidemiology,
H. Lee Moffitt Cancer Center,
Tampa, Florida 

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: In the U.S., approximately 1 in 30 baby boomers are chronically infected with hepatitis C virus. Half of all cases of liver cancer are caused by hepatitis C and liver cancer is one of only three cancer types that are actually increasing in incidence in the US. Because of this, in 2012 the CDC issued a recommendation for universal screening for hepatitis C virus for everyone born between 1945 and 1965 (baby boomers). We wanted to look at the time period after that to see if the rates of screening in that population increased. From 2013-2015 screening among baby boomers only increased by 0.9% (from 11.8% to 12.7%) which indicates we still have a long way to go before we meet our goal of universal screening.  Continue reading

Drinking Coffee Reduced Mortality in Treated HIV-Hepatitis C Co-Infected Patients

MedicalResearch.com Interview with:

Coffee Wikipedia image

Coffee
Wikipedia image

Patrizia Carrieri PhD
INSERM U912 – ORS PACA
IHU – Faculté de Médecine
Marseille, France

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study is based on the longitudinal data of the French  ANRS HEPAVIH cohort of patients with HIV and Hepatitis C co-infection. This cohort was set up thanks to a collaboration between INSERM (National Institute of health and medical research) UMR912 in Marseille, the ISPED (public health and epidemiology institute) in Bordeaux and several hospital/university sites. Our INSERM team in Marseille is specialized in the study of the impact of behaviors on HIV and HCV outcomes, including mortality.

We could think that HCV cure was enough to reduce mortality in HIV-HCV patients as the mortality risk was 80% lower in those who were cured of (i.e. who “cleared”) Hepatitis C thanks to treatment.

However, our study showed that, even after HCV cure, sociobehavioral factors still matter: drinking at least 3 cups of coffee a day was associated with a 50% reduction in mortality risk as well as not smoking which was also associated with a reduced mortality risk. This association between elevated coffee intake and reduced mortality risk is probably due to the properties of polyphenols contained in coffee which can protect the liver and also reduce inflammation.

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Hepatitis C Can Be Safely Treated By Primary Care Providers

MedicalResearch.com Interview with:

Sarah Kattakuzhy, MD Clinical and Administrative Director, DC PFAP Hepatitis Clinical Research Program Assistant Professor, Institute of Human Virology Division of Infectious Diseases University of Maryland 

Sarah Kattakuzhy, MD
Clinical and Administrative Director, DC PFAP Hepatitis Clinical Research Program
Assistant Professor, Institute of Human Virology
Division of Infectious Diseases
University of Maryland  

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The recent introduction of highly effective, well-tolerated direct-acting antiviral (DAA) therapy for hepatitis C virus infection has raised the possibility of rapid treatment expansion and widespread cure. However, the current specialist workforce is insufficient to meet the treatment demands of the 2.7 million Americans living with HCV infection. Several studies of partial task shifting—shared treatment between specialists and primary care providers—have demonstrated success in improving access to HCV care. Yet, information on the success of nonspecialists practicing independent of specialist supervision is limited.

The primary objective of ASCEND was to evaluate the efficacy of Hepatitis C treatment managed independently by 3 community-based provider types—nurse practitioners (NPs), PCPs, and specialists—after a succinct, guideline-driven educational intervention, set within a real-world, urban population.

In this investigation, 516 out of 600 patients achieved SVR, a response rate of 86% (95% CI, 83.0% to 88.7%), with no major safety signals. Rates of SVR were consistent across the 3 provider types—NPs: 89.3% (CI, 83.3% to 93.8%); PCPs: 86.9% (CI, 80.6% to 91.7%); and specialists: 83.8% (CI, 79.0% to 87.8%). Patient loss to follow-up was the major cause of non-SVR.

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High Hepatitis C Cure Rate Using Elbasvir plus Grazoprevir In Chronic Kidney Disease

MedicalResearch.com Interview with:

Annette Bruchfeld MD, PhD Senior Consultant Associate Professor Karolinska Institute Dept of Renal Medicine, M99 Karolinska University Hospital Huddinge Stockholm, Sweden

Dr. Bruchfeld

Annette Bruchfeld MD, PhD Senior Consultant
Associate Professor
Karolinska Institute
Dept of Renal Medicine, M99
Karolinska University Hospital Huddinge
Stockholm, Sweden

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In patients with stage 4–5 chronic kidney disease(CKD), hepatitis C virus (HCV) infection can accelerate the decline in kidney function, impair health-related quality of life (HRQOL), and decrease survival chances of both patients and grafts in transplantation recipients.

In this study additional data from patients with stage 4–5 chronic kidney disease undergoing treatment for HCV infection in the C-SURFER study, including HRQOL and resistance analyses was presented not previously reported for this patient population with gwnotype 1 infection.

The final virological analysis of this study indicated a high cure rate with sustained virological response at 12 weeks after the end of treatment (SVR12) in more than 98% of all treated patients. Even in patients with resistance-associated substitutions (RASs) the SVR was high in 11 (84·6%) of 13 patients genotype 1a infection.

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Single Tablet Triple Therapy Effective For Refractory Hepatitis C

MedicalResearch.com Interview with:
Dr Marc Bourlière

Professeur Associé CHP (Associate Professor PHC)
Chef de service (Head of Department)
Hôpital Saint Joseph
Hépato-Gastroentérologie

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The majority of HCV patients can be cured with combinations of direct-acting antivirals (DAAs); however, there is still 5 to 10% of patients who relapse after treatment with DAAs for whom there are currently no approved therapeutic options available.

In these two international phase 3 studies, we have demonstrated that a single tablet triple regimen combining sofosbuvir, velpastasvir and voxilaprevir (a pangenotypic protease inhibitor) for 12 weeks cured 96% of the patients who had relapsed following prior treatment with DAA regimens including NS5A inhibitors and 98% of the patients who had relapsed following prior treatment with DAA regimens without an NS5A inhibitor. These two studies demonstrate that a pangenotypic retreatment option for this patient population could be soon available.

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Genetic Marker Can Determine Cirrhosis Patients Who Do Not Benefit From Hepatitis C Cure

MedicalResearch.com Interview with:

Dr. Winston Dunn, MD Assistant Professor The University of Kansas Medical Center

Dr. Dunn

Dr. Winston Dunn, MD
Assistant Professor
The University of Kansas Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It is widely believed that everyone with HCV can be cured with the medications now a day. But sadly, about 5% of the patients already have very bad damage done to the liver. We call this decompensated cirrhosis. Our medication is still very effective in curing the virus, but in decompensated cirrhosis, curing the virus is not always enough.

Only about half to two-thirds of patients with decompensated cirrhosis clinically gets better, but the remaining struggles along or even gets worse after the cure. That is the problem. So, our research was to understand why that was.

We used genetic factor to predict which patient would get better and which patient would not. We found that a gene previous found to be predictive of fatty liver and fibrosis is also predictive of recovery in this setting.

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Hepatitis C Can Be Successfully Treated in Homeless Population

MedicalResearch.com Interview with:
Joshua Barocas, MD
Clinical and Research Fellow
Division of Infectious Diseases
Massachusetts General Hospital and Brigham and Women’s Hospital 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Boston Health Care for the Homeless Program began treating HCV-infected individuals with the new oral medications.

Based on clinical experience and previous experience with medication adherence in the setting of HIV, there were no clinical reasons that homeless persons should be excluded.

As a result, we began to track the experience of treated individuals including cure, side effects, and adherence.

We found that in the initial group of treated individuals, 62 of 64 persons achieved SVR. There were minimal side effects and adherence was excellent

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Most Baby Boomers Still Not Receiving Recommended Hepatitis C Testing

MedicalResearch.com Interview with:

Stacey Fedewa, MPH Strategic Director, Screening and Risk Factor Surveillance Surveillance and Health Services Research program American Cancer Society

Dr. Fedewa

Stacey Fedewa, Ph.D.
Strategic Director, Risk Factors & Screening Surveillance
American Cancer Society
Atlanta GA 30303-1002

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: About 3.5 million people in the US are chronically infected with Hepatitis C, the majority are unaware of their infection despite the availability of treatments that may reduce the risk of HCV-related diseases such as liver cancer. About 80% of those with the infection are baby-boomers (people born between 1945-1965). To help reduce growing burden of these HCV-associated diseases, the U.S. Preventive Services Task Force (USPSTF) recommended one-time HCV testing for baby-boomers in 2013.

We examined nationwide data between 2013-2015 to see if HCV testing in baby-boomers has increased since the USPSTF recommendation.  We found that only about 14% of baby-boomers had ever been tested in 2015, which represented a very small increase from 2013 where testing prevalence was about 12%. In 2015, we estimated that there were about 76.2 million baby boomers and only 10.5 reported ever receiving HCV testing.

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Incidence, Risk factors and Prevention of Hepatitis C Reinfection

MedicalResearch.com Interview with:
Naveed Zafar Janjua, MBBS, MSc, DrPH
Senior Scientist, Clinical Prevention Services
BC Centre for Disease Control
Clinical Associate Professor, School of Population and Public Health
University of British Columbia

MedicalResearch.com: What is the background for this study?

Response: Hepatitis C is a viral infection that affects the liver. About quarter of people infected with hepatitis C clear their infection spontaneously rest develop chronic infection. Left untreated, hepatitis C could results in scarring of liver (liver cirrhosis), liver cancer or death. New anti-viral drugs are highly effective in curing hepatitis C, about than 95 per cent of those treated can be cured. However, people who engage in high risk activities such as people who inject drugs (PWID) remain at risk of reinfection. As the cost of treatment is very high, re-infection is a concern among physicians and policy makers in Canada and around the world.

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Single-Step Testing Can Improve Access To Hepatitis C Testing

MedicalResearch.com Interview with:

J. Morgan Freiman, MD Infectious disease research fellow Boston Medical Center

Dr. Morgan Freiman

J. Morgan Freiman, MD
Infectious disease research fellow
Boston Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Freiman:  There are 130-150 million persons infected with chronic HCV with 75% of all cases occurring in low- and middle- income countries (LMICs). Diagnosis is a 2-step process that starts with screening for exposure with an assay that detects antibodies to HCV (anti-HCV), followed by nucleic acid testing (NAT) for persons with reactive anti-HCV to measure HCV ribonucleic acid (RNA) and confirm active viremia.

In LMICs diagnostic capacity is low, and fewer than 1% of patients are aware of their infection. Additionally, a significant proportion of patients who test positive for anti-HCV are lost to follow-up before nucleic acid testing. The 2-step diagnostic process is thus a major bottleneck to the HCV cascade of care. Testing for hepatitis C virus core antigen (HCVcAg) is a potential replacement for NAT.

Our systematic review evaluated the accuracy of diagnosis of active HCV infection among adults and children for 5 commercially available HCVcAg tests compared with NAT. We found that HCVcAg assays with signal amplification have high sensitivity, high specificity, and have the potential to replace NAT in settings with high HCV prevalence.

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Caffeine May Slow Progression of Liver Fibrosis in Chronic Hepatitis C

MedicalResearch.com Interview with:

Sikarin Upala MD, MS, LLB Internal Medicine, Bassett Medical Center and Columbia University College of Physicians and Surgeons, Cooperstown, New York Preventive and Social Medicine Mahidol University, Bangkok, Thailand

Dr. Sikarin Upala

Sikarin Upala MD, MS, LLB
Internal Medicine, Bassett Medical Center and Columbia University College of Physicians and Surgeons, Cooperstown, New York
Preventive and Social Medicine
Mahidol University, Bangkok, Thailand

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Upala: Chronic hepatitis C virus infection is the most common cause of chronic liver disease and cirrhosis as well as the most common cause of liver transplantation in the United States. As caffeine has been found to be related to decreased liver enzymes, chronic liver disease,cirrhosis, and risk of hepatocellular carcinoma in several liver disease pathologies. There is inconclusive findings on the effect of caffeine on hepatitis C infected patients. Thus, we conducted a systematic review and meta-analysis to summarize the effect of caffeine consumption in patients with chronic hepatitis C.

We found that caffeine consumers have a 61% reduced risk of developing advanced hepatic fibrosis, which is one of the consequence of chronic hepatitis C. Our meta-analysis result is in the same way with other studies who found that coffee consumption could prevent the development of hepatic fibrosis in patients with liver disease. However, we cannot conclude about the effect of caffeine on HCV viral load as there is not enough information.

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Hepatitis C Raises Risk of HPV Head and Neck Cancers

MedicalResearch.com Interview with:

Harrys A. Torres, MD, FACP, FIDSA Associate Professor Director of Hepatitis C Clinic Department of Infectious Diseases, Infection Control and Employee Health The University of Texas MD Anderson Cancer Center Houston TX 77030

Dr. Harrys Torres

Harrys A. Torres, MD, FACP, FIDSA
Associate Professor
Director of Hepatitis C Clinic
Department of Infectious Diseases, Infection Control and Employee Health
The University of Texas MD Anderson Cancer Center
Houston TX 77030

Medical Research: What is the background for this study? What are the main findings?

Dr. Torres: Hepatitis C virus (HCV) is an oncogenic virus and is associated with an increased risk of liver cancer and certain types of non-Hodgkin lymphomas. In 2009, at MD Anderson Cancer Center, we set up the first clinic in the United States, and probably in the world, specifically devoted to managing HCV infection in cancer patients. In the clinic, we expected to see a number of patients with liver cancers and non-Hodgkin’s lymphoma, as these have documented associations with HCV. Unexpectedly, we saw a high number of HCV-infected patients with head and neck cancers, and wondered whether there was an undiscovered association between having the infection and head and neck cancers. To explore this, we conducted a case-control study using 409 head and neck cancer subjects (164 oropharyngeal, 245 non-oropharyngeal [oral cavity, nasopharynx, larynx] cancers) and 694 control subjects with other smoking-associated cancers (378 lung, 168 esophagus, and 148 urinary bladder cancers), and compared the prevalence of HCV infection in the two groups. We observed a high prevalence of HCV infection in oropharyngeal (14%) and non-oropharyngeal (20%) cancer patients when compared to control subjects (6.5%). After adjusting for confounders such as smoking, alcohol intake, and socioeconomic status, HCV-infected individuals were 2.04 times more likely to have oropharyngeal cancers and 2.85 times more likely to have non-oropharyngeal cancers. Of note, HCV was associated only with patients with oropharyngeal cancers that tested positive for human papilloma virus, which is one of the main virus linked with increased risk of oropharyngeal cancers.

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All Baby Boomers Should Be Screened At Least Once For Hepatitis C

Dr Waridibo Allison MD PhD Department of Medicine, Division of Infectious Diseases and Immunology New York Langone University School of Medicine New York, NY 10016MedicalResearch.com Interview with:
Dr Waridibo Allison MD PhD
Department of Medicine, Division of Infectious Diseases and Immunology
New York Langone University School of Medicine
New York, NY 10016

Medical Research: What is the background for this study? What are the main findings?

Dr. Allison: It was found that among 383 baby boomers presenting to a large urban emergency department in New York City the prevalence of HCV antibody reactivity was 7.3%. Only four patients were successfully linked to care and only one patient was started on HCV treatment. The study highlights the possibility that there may be problems in linking patients to care from the ED compared to other clinical settings such as primary care and inpatient settings. It was concluded that only with strategies to improve linkage to care could a screening program for baby boomers be recommended in the ED where the study was carried out.

The study additionally had a qualitative component and, via structured interviews, evaluated knowledge about HCV infection amongst baby boomers presenting to the ED. Overall knowledge was good but some misconceptions about transmission persisted and many patients mistakenly believed that there is a vaccine for hepatitis C.

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Screening and Treating Hepatitis C In Prisons Cost Effective For Wider Community

Dr. Tianhua He MD Beijing China, 100005

Dr. Tianhua He

MedicalResearch.com Interview with:
Dr. Tianhua He MD
Beijing China, 100005

Medical Research: What is the background for this study? What are the main findings?

Response: The prevalence of Hepatitis C (HCV) infection is high (17%) in US prisons. And about 30% of all HCV-infected persons in US spend part of the year in correctional facilities.

However, most state prisons offer no routine screening for Hepatitis C. Undiagnosed and untreated inmates, after releasing, will contribute to the spread of the disease in society. HCV infection is now the leading cause of liver cancer, and the most common indication for liver transplant. With the recently launched highlyy effective antiviral drugs, previous studies have shown that treating infected prisoners was cost-effective. However, no studies yet have evaluated the effect of interventions including screening and treatment among prisoners on prevention of Hepatitis C transmission and reduction of disease burden, neither the cost effectiveness of such interventions.

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New HCV Treatment Improves Hepatitis C Cirrhosis

Dr. Michael P. Curry, MD Medical Director for Liver Transplantation Harvard Medical Faculty Physicians Beth Israel Deaconess Medical Center

Dr. Curry

MedicalResearch.com Interview with:
Dr. Michael P. Curry, MD
Medical Director for Liver Transplantation
Harvard Medical Faculty Physicians
Beth Israel Deaconess Medical Center

Medical Research: What is the background for this study? What are the main findings

Dr. Curry: As the population that is infected with the hepatitis C virus (HCV) ages, the number of patients with decompensated cirrhosis is expected to increase. For many years, the only treatment option for these patients was liver transplantation. Recently, however, clinical trials of newly approved direct-acting antiviral agents (DAAs) have shown that it is possible to treat HCV infection safely and effectively in patients with decompensated cirrhosis. We conducted this Phase 3, open-label trial to assess the efficacy and safety of a fixed dose combination of sofosbuvir/velpatasvir with or without ribavirin for 12 weeks or sofosbuvir/velpatasvir for 24 weeks in patients infected with hepatitis C virus genotypes 1 through 6 and with decompensated cirrhosis. We found that treatment with sofosbuvir/velpatasvir resulted in high rates of sustained virologic response (SVR) and early improvements in hepatic function in this patient population. SVR rates were 83 percent  in patients who received sofosbuvir/velpatasvir for 12 weeks, 94 percent among those who received sofosbuvir/velpatasvir plus ribavirin, and 86 percent among those who received sofosbuvir/velpatasvir for 24 weeks.

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Combination Medication Effective For Hepatitis C Recurrence After Liver Transplantation

MedicalResearch.com Interview with:
Dr. Audrey Coilly MD
Fellow at the Centre Hepato-Biliaire
Paul Brousse Hospital
Villejuif, France

Medical Research: What is the background for this study? What are the main findings?

Dr.
Coilly: Hepatitis C (HCV) recurrence used to be a major issue during two decades for patients transplanted with an active HCV infection at the time of transplantation impacting both patient and graft survival. The combination of sofosbuvir and daclatasvir has not been studied after liver transplantation. The main findings are a high efficacy profile with an overall SVR12 rate of 95%. The safety profile is also good​. The most frequent adverse event is anemia, particularly when ribavirin is still used.

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Cancer Risk Elevated In Patients With Hepatitis C

Lisa M. Nyberg, MD, MPH Transplant Hepatologist Director, Hepatology Research Kaiser Permanente, Garfield Specialty Center San Diego, CA  92111MedicalResearch.com Interview with:
Lisa M. Nyberg, MD, MPH
Transplant Hepatologist
Director, Hepatology Research
Kaiser Permanente, Garfield Specialty Center
San Diego, CA  92111

Medical Research: What is the background for this study? What are the main findings?

Dr. Nyberg: The overall cancer rates were higher in patients with Hepatitis C (HCV) vs those without HCV. Of note, though, the HCV cohort had higher rates of alcohol abuse, tobacco use, cirrhosis and diabetes mellitus (DM). However, even after stratification for the variables alcohol abuse, tobacco use, body mass index (BMI) and DM; the increased cancer rates remained significant for total cancer sites, liver cancer and NHL.

Note that this study does not establish a cause and effect relationship between Hepatitis C and cancer. A strength of this study is that it is an evaluation of a large patient population (n=35,712 with HCV and 5,297,191 without HCV). Limitations of the study are those inherent in epidemiological studies using large databases. For example, confounders may not be accurately recorded in automated databases (smoking and alcohol abuse may be under-recorded).

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Single Pill Combination Therapy For Some Hepatitis C Subtypes

Stefan Zeuzem, MDProfessor of Medicine Chief Department of Medicine Goethe University Hospital FrankfurtMedicalResearch.com Interview with:
Stefan Zeuzem, MD
Professor of Medicine
Chief Department of Medicine
Goethe University Hospital
Frankfurt

Medical Research: What is the background for this study? What are the main findings?

Dr. Zeuzem: Interferon- and ribavirin-free regimens are needed to treat HCV infection. The objective of the study was to evaluate the safety and efficacy of grazoprevir (NS3/4A-protease-inhibitor) and elbasvir (NS5A-inhibitor) in previously untreated patients with chronic hepatitis C (without and with liver cirrhosis). Among 421 participants, 194 (46%) were women, 157 (37%) were non-white, 382 (91%) had genotype-1 infection, and 92 (22%) had cirrhosis. Of 316 patients receiving immediate treatment, 299/316 achieved SVR12 (undetectable HCV 12 weeks after treatment), including 144/157  with genotype-1a, 129/131  with genotype-1b, 18/18  with genotype-4, 8/10 with genotype-6, 68/70 with cirrhosis, and 231/246 without cirrhosis. Virologic failure occurred in 13 patients including 1 breakthrough and 12 relapses, and was associated with baseline NS5A-polymorphisms and emergent NS3- and/or NS5A-variants. Serious adverse events occurred in 9 (2.8%) and 3 (2.9%) patients in the active and placebo arms, respectively; none were considered drug-related.
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