Showing posts with label Post Treatment. Show all posts
Showing posts with label Post Treatment. Show all posts

Friday, August 3, 2018

Symptom burden and comorbid medical conditions in patients with HCV initiating direct acting antiviral therapy

A comprehensive assessment of patient reported symptom burden, medical comorbidities, and functional well being in patients initiating direct acting antiviral therapy for chronic hepatitis C: Results from a large US multi-center observational study

A comprehensive understanding of baseline symptom burden in patients with HCV is necessary to lay the groundwork for subsequent real-world investigations of potential changes in symptoms during DAA therapy and after virologic cure. We aimed to characterize patient-reported symptoms, medical conditions, and functional well-being in a large multi-center US cohort who initiated DAA therapy in clinical practices in 2016-2017. Our secondary aim was to evaluate sociodemographic/SDoH, liver-related, and other clinical features associated with these health outcomes.

Published: August 1, 2018 

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Abstract
Background
Symptom burden, medical comorbidities, and functional well-being of patients with chronic hepatitis C virus (HCV) initiating direct acting antiviral (DAA) therapy in real-world clinical settings are not known. We characterized these patient-reported outcomes (PROs) among HCV-infected patients and explored associations with sociodemographic, liver disease, and psychiatric/substance abuse variables.

Methods and findings
PROP UP is a large US multicenter observational study that enrolled 1,600 patients with chronic HCV in 2016–2017. Data collected prior to initiating DAA therapy assessed the following PROs: number of medical comorbidities; neuropsychiatric, somatic, gastrointestinal symptoms (PROMIS surveys); overall symptom burden (Memorial Symptom Assessment Scale); and functional well-being (HCV-PRO). Candidate predictors included liver disease markers and patient-reported sociodemographic, psychiatric, and alcohol/drug use features. Predictive models were explored using a random selection of 700 participants; models were then validated with data from the remaining 900 participants. The cohort was 55% male, 39% non-white, 48% had cirrhosis (12% with advanced cirrhosis); 52% were disabled or unemployed; 63% were on public health insurance or uninsured; and over 40% had markers of psychiatric illness. The median number of medical comorbidities was 4 (range: 0–15), with sleep disorders, chronic pain, diabetes, joint pain and muscle aches being present in 20–50%. Fatigue, sleep disturbance, pain and neuropsychiatric symptoms were present in over 60% and gastrointestinal symptoms in 40–50%. In multivariable validation models, the strongest and most frequent predictors of worse PROs were disability, unemployment, and use of psychiatric medications, while liver markers generally were not.

Conclusions
This large multi-center cohort study provides a comprehensive and contemporary assessment of the symptom burden and comorbid medical conditions in patients with HCV treated in real world settings. Pain, fatigue, and sleep disturbance were common and often severe. Sociodemographic and psychiatric markers were the most robust predictors of PROs. Future research that includes a rapidly changing population of HCV-infected individuals needs to evaluate how DAA therapy affects PROs and elucidate which symptoms resolve with viral eradication.

Saturday, April 29, 2017

Practice update for managing patients cured of HCV infection

AGA Institute releases practice update for managing patients cured of HCV infection
Direct-acting antiviral (DAA) regimens for chronic HCV infection achieve high rates of SVR and have replaced interferon (IFN) in many countries. The current definition of SVR is undetectability of HCV RNA at 12 weeks after treatment (SVR12). Patients who achieve an SVR have a less than 1% risk of relapse and are considered cured.

Patients cured of HCV may experience reductions in the risk for death and hepatocellular carcinoma (HCC), as well as regression of liver changes including fibrosis or cirrhosis, but may still have higher rates of HCV-related complications than the general population. Patients who have already developed liver damage at the time of achieving SVR may be particularly at risk for future complications.
Continue reading....

Full Text
Gastroenterology
May 2017 Volume 152, Issue 6, Pages 1578–1587
Online
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American Gastroenterological Association Institute Clinical Practice Update—Expert Review: Care of Patients Who Have Achieved a Sustained Virologic Response After Antiviral Therapy for Chronic Hepatitis C Infection
Chronic hepatitis C virus infection is well-recognized as a common blood-borne infection with global public health impact affecting 3 to 5 million persons in the United States and more than 170 million persons worldwide. Chronic hepatitis C virus infection is associated with significant morbidity and mortality due to complications of liver cirrhosis and hepatocellular carcinoma. Current therapies with all-oral direct-acting antiviral agents are associated with high rates of sustained virologic response (SVR), generally exceeding 90%. SVR is associated with a reduced risk of liver cirrhosis, hepatic decompensation, need for liver transplantation, and both liver-related and all-cause mortality.

However, a subset of patients who achieve SVR will remain at long-term risk for progression to cirrhosis, liver failure, hepatocellular carcinoma, and liver-related mortality. Limited evidence is available to guide clinicians on which post-SVR patients should be monitored vs discharged, how to monitor and with which tests, how frequently should monitoring occur, and for how long. In this clinical practice update, available evidence and expert opinion are used to generate best practice recommendations on the care of patients with chronic hepatitis C virus who have achieved SVR.

The battle against hepatitis C virus (HCV) has culminated in remarkably high rates of sustained virologic response (SVR) conferred by 6 currently approved interferon (IFN)-free direct-acting antiviral (DAA) regimens against genotypes 1−6 HCV.1, 2, 3, 4, 5, 6 In the many countries where these regimens are available, the use of IFN has essentially ceased. Follow-up studies and cumulative experience have affirmed that, as with earlier IFN-based therapy, SVR is tantamount to virologic cure. Fewer than 1% of patients relapse after SVR, defined during the years of IFN therapy as HCV RNA undetectability 24 weeks, and more recently as 12 weeks, after completion of treatment (SVR12).7, 8, 9, 10, 11, 12, 13

With the increasingly frequent opportunity to celebrate virologic cure with patients comes the corresponding need to advise them about whether, when, and for how long ongoing care for liver disease is needed. Therefore, it is critical to identify the ongoing risks for the individual patient and the measures needed to mitigate those risks. Numerous studies in patients cured of HCV by IFN-based therapy have demonstrated reductions in all-cause mortality, liver-related mortality, need for liver transplantation, variceal bleeding, and hepatocellular carcinoma (HCC),14, 15, 16 as well as a reduction in mortality from extrahepatic complications.17 Regression of fibrosis and even cirrhosis has been documented, as has been demonstrated in other liver diseases when the underlying cause has been controlled.18, 19, 20, 21 Nevertheless, reduction in risk is still potentially relative rather than absolute, and ongoing surveillance and intervention may be required in some patients to reduce complications arising from liver damage that has already accrued by the time SVR has been attained. Of greatest concern is the ongoing risk of HCC in patients with pre-existing advanced fibrosis or cirrhosis. In this article, the considerations surrounding the care of patients who have achieved SVR will be discussed, and proposed recommendations will be presented
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Tuesday, April 25, 2017

Management of Cirrhotic Patients After Successful HCV Eradication

Management of Cirrhotic Patients After Successful HCV Eradication
Kwok, R.M. & Tran, T.T.
Curr Treat Options Gastro (2017).
doi:10.1007/s11938-017-0134-2

First Online: 24 April 2017

Chronic hepatitis C (HCV) is a hepatotropic virus which, when untreated, can lead to progressive inflammation and fibrosis resulting in cirrhosis, hepatocellular carcinoma (HCC), and decompensations related to end-stage liver disease. The relatively recent introduction of all oral, interferon-free, direct-acting antiviral medications against HCV has transformed the management of these patients. Previous treatment regimens were prolonged, poorly tolerated, and frequently did not result in cure. Current therapies achieve sustained viral response (SVR) in the vast majority of patients including those with decompensated liver disease; a previously challenging population to treat. These successes will result in significant numbers of cirrhotic patients requiring management after SVR. Although many complications of cirrhosis are improved in this setting, regular follow-up of HCC, esophageal varices, and other sequelae of cirrhosis will be necessary. This chapter will review the management of cirrhosis in HCV patients achieving cure.

Wednesday, March 29, 2017

Care of Patients Who Have Achieved a Sustained Virologic Response (SVR) Following Antiviral Therapy for Chronic Hepatitis C Infection

AGA Institute releases practice update for managing patients cured of HCV infection
The American Gastroenterological Association (AGA) Institute released a practice update on managing patients with chronic hepatitis C virus (HCV) infection who have attained a sustained virologic response (SVR) after antiviral treatment. The clinical practice update was published in Gastroenterology.

Direct-acting antiviral (DAA) regimens for chronic HCV infection achieve high rates of SVR and have replaced interferon (IFN) in many countries. The current definition of SVR is undetectability of HCV RNA at 12 weeks after treatment (SVR12). Patients who achieve an SVR have a less than 1% risk of relapse and are considered cured.

Patients cured of HCV may experience reductions in the risk for death and hepatocellular carcinoma (HCC), as well as regression of liver changes including fibrosis or cirrhosis, but may still have higher rates of HCV-related complications than the general population. Patients who have already developed liver damage at the time of achieving SVR may be particularly at risk for future complications.
Continue reading.....

Updated
May 2017
Full Text Online
Expert Review
American Gastroenterological Association Institute Clinical Practice Update—Expert Review: Care of Patients Who Have Achieved a Sustained Virologic Response After Antiviral Therapy for Chronic Hepatitis C Infection

Online

Gastroenterology
Articles in Press

AGA Institute Clinical Practice Update: Care of Patients Who Have Achieved a Sustained Virologic Response (SVR) Following Antiviral Therapy for Chronic Hepatitis C Infection
Ira M. Jacobson M.D., Joseph K. Lim, M.D., and Michael W. Fried, M.D.

ACCEPTED MANUSCRIPT
DOI: http://dx.doi.org/10.1053/j.gastro.2017.03.018

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Abstract
Chronic hepatitis C virus (HCV) infection is well-recognized as a common blood borne infection with global public health impact, affecting 3 to 5 million persons in the U.S. and over 170 million persons worldwide. Chronic HCV infection is associated with significant morbidity and mortality due to complications of liver cirrhosis and hepatocellular carcinoma (HCC). Current therapies with all-oral directly acting antiviral agents (DAAs) are associated with high rates of sustained virologic response (SVR), generally exceeding 90%. SVR is associated with a reduced risk of liver cirrhosis, hepatic decompensation, need for liver transplantation, and both liver-related and all-cause mortality. However, a subset of patients who achieve SVR will remain at long-term risk for progression to cirrhosis, liver failure, HCC, and liver-related mortality. Limited evidence is available to guide clinicians on which post-SVR patients should be monitored versus discharged, how to monitor and with which tests, how frequently should monitoring occur, and for how long. In this clinical practice update, available evidence and expert opinion are used to generate best practice recommendations on the care of patients with chronic HCV who have achieved SVR.

Index
Assessment of HCV RNA after SVR12 has been attained
With the initiation of trials of DAA regimens, initially in combination with interferon and later
without it, the attainment of SVR 12 weeks after completion of treatment replaced SVR24 as
the primary endpoint, defined as undetectable HCV RNA on a highly sensitive PCR assay (lower
limit of detection <12 IU/mL).  This transition was based upon the rarity of relapse after follow
up week 12, and it helped move the field ahead by shortening the intervals between successive
trials in development programs (22). It has become apparent that late relapse beyond this time
point is no more common, and perhaps less so, than it was after interferon-based therapy

Ongoing surveillance for hepatocellular carcinoma after SVR
Is HCC risk after SVR exclusive to patients with advanced fibrosis and cirrhosis?
Can HCC surveillance ever be discontinued?
How should screening for, and management of, varices be affected by SVR?
Should patients be routinely monitored for regression of advanced fibrosis or
cirrhosis?

Recurrent HCC After SVR
Reinfection
Lifestyle Measures
Conclusions
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