A prospective, interventional, multi-center trial to evaluate the Efficacy and Safety of Sofosbuvir-Velpatasvir for the treatment of Chronic Hepatitis C patients in Pakistan.
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Baseline characteristics in patients without cirrhosis and in patients with compensated cirrhosis
Baseline characteristics in patients without cirrhosis and in patients with compensated cirrhosis
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Background
In Pakistan, there is a paucity of published clinical data regarding the efficacy of sofosbuvir-velpatasvir in the management of patients with hepatitis C without cirrhosis or with compensated cirrhosis.
Methods
A prospective, open-label, multicenter, interventional trial was conducted in patients with hepatitis C without cirrhosis or with compensated cirrhosis. Hepatitis C patients without cirrhosis or with compensated cirrhosis were screened, and 133 patients were enrolled in the study. They received sofosbuvir 400 mg plus velpatasvir 100 mg combination once daily for 12 weeks. Patients were followed up for six months after the start of therapy. Hepatitis C viral load was assessed at baseline, at week 12, and after 24 weeks following the start of the treatment. The trial was prospectively registered with the Iranian Registry of Clinical Trials (IRCT) with the identification number IRCT20170614034526N4.
Results
Among enrolled patients, 79 were male, and 54 were female. Ninety-five (71.4%) patients were without cirrhosis, and 38 had compensated cirrhosis. Patients without cirrhosis had a mean age of 45.90 ±10.99 years, and patients with compensated cirrhosis had a mean age of 52.60 ±12.29 years. As per the intention-to-treat analysis, all patients without cirrhosis and 35 (92.1%) patients with compensated cirrhosis achieved undetectable viral load hepatitis C virus (HCV) ribonucleic acid (RNA) of <15 IU/mL at 12 weeks from the start of treatment. Eighty-six (90.5%) patients without cirrhosis achieved sustained virologic response 12 weeks after the end of therapy. Patients with compensated cirrhosis experienced more adverse events (31.5%) than patients without cirrhosis (20.15%).
Conclusion
Direct-acting antiviral therapy using sofosbuvir and velpatasvir combination is effective and safe in HCV patients without cirrhosis and patients with compensated cirrhosis.
Background In Pakistan, there is a paucity of published clinical data regarding the efficacy of sofosbuvir-velpatasvir in the management of patients with hepatitis C without cirrhosis or with compensated cirrhosis. Methods A prospective, open-label, multicenter, interventional trial was conducted in patients with hepatitis C without cirrhosis or with compensated cirrhosis. Hepatitis C patients without cirrhosis or with compensated cirrhosis were screened, and 133 patients were enrolled in the study. They received sofosbuvir 400 mg plus velpatasvir 100 mg combination once daily for 12 weeks. Patients were followed up for six months after the start of therapy. Hepatitis C viral load was assessed at baseline, at week 12, and after 24 weeks following the start of the treatment. The trial was prospectively registered with the Iranian Registry of Clinical Trials (IRCT) with the identification number IRCT20170614034526N4. Results Among enrolled patients, 79 were male, and 54 were female. Ninety-five (71.4%) patients were without cirrhosis, and 38 had compensated cirrhosis. Patients without cirrhosis had a mean age of 45.90 ±10.99 years, and patients with compensated cirrhosis had a mean age of 52.60 ±12.29 years. As per the intention-to-treat analysis, all patients without cirrhosis and 35 (92.1%) patients with compensated cirrhosis achieved undetectable viral load hepatitis C virus (HCV) ribonucleic acid (RNA) of <15 IU/mL at 12 weeks from the start of treatment. Eighty-six (90.5%) patients without cirrhosis achieved sustained virologic response 12 weeks after the end of therapy. Patients with compensated cirrhosis experienced more adverse events (31.5%) than patients without cirrhosis (20.15%). Conclusion Direct-acting antiviral therapy using sofosbuvir and velpatasvir combination is effective and safe in HCV patients without cirrhosis and patients with compensated cirrhosis.
Protocol summary
Study aim
To evaluate the safety & efficacy of Sofosbuvir-Velpatasvir combination in real world setting in Pakistan. Further, this study aims to assess sustained virologic response at 12 weeks after the end of therapy.
Design
prospective, open label, single arm, intervention & multi center trial.
Settings and conduct
Study is to be conducted at Gastroenterology department in Jinnah Post-graduate Medical center Karachi, Jinnah Hospital Lahore, Gulab Devi Hospital Lahore, Hayatabad Medical Complex Peshawar, and Pakistan Institute of Medical Sciences, Islamabad, Pakistan. Hepatitis-C patients visiting gastroenterology department of the mentioned institutes would be enrolled after meeting selection criteria. Treatment naive or treatment experienced patients would be prescribed sofosbuvir-velpatasvir combination for 12 weeks as per physician's discretion. Patients would be followed at week 04, week 12 and week 24 of the baseline visit.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Subjects willing to undergo screening and sign informed consent. Male or female outpatients ≥18 years of age. Serologically and histologically proven CHC, detectable HCV RNA, elevated ALT, and compensated liver disease.
Exclusion Criteria: Unable to give written informed consent. Pregnant and/or Nursing Women. Contraindicated to medicine or any of the component of prescribed therapy
Primary Outcome: Sustained Virologic Response (SVR) assessed at week 24 from baseline visit through HCV-RNA PCR. Secondary Outcome: End of treatment response (ETR) would be assessed at week 12 from baseline visit through HCV-RNA PCR.
General information
Reason for update
Acronym
CAVES-IT
IRCT registration information
IRCT registration number:IRCT20170614034526N4
Registration date:2019-03-28, 1398/01/08
Registration timing:retrospective
Last update:2020-01-07, 1398/10/17
Update count:1
Registration date
2019-03-28, 1398/01/08
Registrant information
Name
Dr. Sharib Syed Muhammad
Name of organization / entity
Hilton Pharma Pvt Ltd
Country
Pakistan
Phone
(021) 111-123-000 Ext:428
Email address
sharibsyed@hiltonpharma.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-02, 1397/01/13
Expected recruitment end date
2018-06-30, 1397/04/09
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
A prospective, interventional, multi-center trial to evaluate the Efficacy and Safety of Sofosbuvir-Velpatasvir for the treatment of Chronic Hepatitis C patients in Pakistan.
Public title
Efficacy & Safety of Velpatasvir-Sofosbuvir combination in treatment of Hepatitis-C patients of Pakistan, Phase-IV Interventional Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects willing to undergo screening and sign informed consent
Male or female outpatients ≥18 years of age
Serologically and histologically proven CHC, detectable HCV RNA, elevated ALT, and compensated liver disease.
Exclusion criteria:
Unable to give written informed consent
Pregnant and/or Nursing Women
Contraindicated to medicine or any of the component of prescribed therapy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
155
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jinnah Postgraduate Medical Center
Street address
Rafiqui Shaheed Road, Near National Institute of Child Health (NICH,
City
Karachi
Postal code
75510
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
F.2-81-IRB/2018-GENL/7065/JPMC
Health conditions studied
1
Description of health condition studied
Chronic Hepatitis-C
ICD-10 code
B18.2
ICD-10 code description
Chronic viral hepatitis C
Primary outcomes
1
Description
Sustained Virologic Response (SVR)
Timepoint
Assessed at week 24 from the baseline visit or start of therapy
Method of measurement
HCV-RNA PCR
Secondary outcomes
1
Description
End of Treatment Response (ETR)
Timepoint
assessed at week 12 from baseline visit or start of therapy.
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
To maintain the participants' confidentiality, however data would be made available if Ethics committee and local regulatory bodies demands.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Trial results
Please tick if results have been published
Yes
Summary result posting date
2020-01-07, 1398/10/17
Table of baseline comparison
Participant flow diagram
Table of variable outcomes' results
Baseline characteristics in patients without cirrhosis and in patients with compensated cirrhosis
Table of adverse events
First publication date
2020-01-01, 1398/10/11
Abstract of published paper
Background
In Pakistan, there is a paucity of published clinical data regarding the efficacy of sofosbuvir-velpatasvir in the management of patients with hepatitis C without cirrhosis or with compensated cirrhosis.
Methods
A prospective, open-label, multicenter, interventional trial was conducted in patients with hepatitis C without cirrhosis or with compensated cirrhosis. Hepatitis C patients without cirrhosis or with compensated cirrhosis were screened, and 133 patients were enrolled in the study. They received sofosbuvir 400 mg plus velpatasvir 100 mg combination once daily for 12 weeks. Patients were followed up for six months after the start of therapy. Hepatitis C viral load was assessed at baseline, at week 12, and after 24 weeks following the start of the treatment. The trial was prospectively registered with the Iranian Registry of Clinical Trials (IRCT) with the identification number IRCT20170614034526N4.
Results
Among enrolled patients, 79 were male, and 54 were female. Ninety-five (71.4%) patients were without cirrhosis, and 38 had compensated cirrhosis. Patients without cirrhosis had a mean age of 45.90 ±10.99 years, and patients with compensated cirrhosis had a mean age of 52.60 ±12.29 years. As per the intention-to-treat analysis, all patients without cirrhosis and 35 (92.1%) patients with compensated cirrhosis achieved undetectable viral load hepatitis C virus (HCV) ribonucleic acid (RNA) of <15 IU/mL at 12 weeks from the start of treatment. Eighty-six (90.5%) patients without cirrhosis achieved sustained virologic response 12 weeks after the end of therapy. Patients with compensated cirrhosis experienced more adverse events (31.5%) than patients without cirrhosis (20.15%).
Conclusion
Direct-acting antiviral therapy using sofosbuvir and velpatasvir combination is effective and safe in HCV patients without cirrhosis and patients with compensated cirrhosis.