Effects of Harvoni in Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection
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|ClinicalTrials.gov Identifier: NCT02597166|
Recruitment Status : Completed
First Posted : November 5, 2015
Last Update Posted : October 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic Cirrhosis, Decompensated||Drug: Ledipasvir/Sofosbuvir||Phase 3|
Hepatitis C virus (HCV) is one of the most common causes of liver cirrhosis worldwide. The progression of liver cirrhosis can lead to a myriad of complications including ascites, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, and hepatocellular carcinoma. The development of these complications or decompensation can lead to a dismal survival of 50% at 6 months, especially if the underlying cause of the liver cirrhosis is not treated. The cost of caring for these patients with decompensated cirrhosis is extremely high. Despite this, every effort is being made to maintain these patients in reasonable health until liver transplant becomes available for them. Yet these patients continue to have poor quality of life because of the various symptoms related to decompensated cirrhosis, and spend much time visiting health care facilities for both outpatient and inpatient care.
The recent availability of potent and effective anti-viral therapy has revolutionized the management of patients with hepatitis C infection. With a >90% cure rate, many patients with compensated cirrhosis, once treated, will not progress further to develop decompensation. With the passage of time, the liver cirrhosis may even regress to a non-cirrhotic state. Published data on treatment of decompensated cirrhosis with hepatitis C infection is still scanty. However, patients with decompensated cirrhosis due to hepatitis B infection who received effective anti-viral therapy not only improved their overall clinical status, many of these patients reverted from a decompensated to a compensated state, associated with improved survival. Likewise, patients with alcoholic cirrhosis who abstain from alcohol will also have improvement in liver function and reduction in complications of cirrhosis. Therefore, treatment of decompensated cirrhotic patients with hepatitis C is expected to show the same beneficial effects, because the underlying cause of cirrhosis is coming under control.
The primary objective of this study is to assess the effects of anti-viral therapy on the clinical status, quality of life and survival of patients with decompensated cirrhosis due to chronic hepatitis C genotype 1 infection.
After completion of all initial investigations, patients will be started on Harvoni 90 mg ledipasvir/400 mg sofosbuvir (one tablet) daily. The course of treatment will be 24 weeks. Patients will be reviewed at monthly intervals as per standard of care. At each clinic visit, patients with have blood tests including complete blood count, renal function, electrolytes, liver enzyme and liver function tests, HCV RNA will be done at week 4, week 12, week 24 during treatment, and then again at week 12 post completion of treatment. Annual ultrasounds and surveillance gastroscopies will be organized as per standard of care.
Patient will be followed for 1 year post completion of treatment, and have repeat quality of life questionnaires at end of treatment, and thereafter at 6 and 12 months. Patients will also be monitored for the development of further complications of cirrhosis (if any), hospital admissions, reasons for hospital admissions, lengths of hospital stays, survival, and liver transplantation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Anti-Viral Therapy on the Clinical Status, Quality of Life, and Survival of Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
Each tablet contains 90 mg ledipasvir and 400 mg sofosbuvir, given orally, once daily for 24 weeks.
Each tablet of Harvoni contains 90 mg ledipasvir and 400 mg sofosbuvir.
Other Name: Harvoni
- Improvement of quality of life based on Chronic Liver Disease Questionnaire [ Time Frame: one year ]Improvement of quality of life based on Chronic Liver Disease Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597166
|University Health Network - Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Florence Wong, MD||University Health Network - Toronto General Hospital|