Neoplasms

All Conditions

Digestive System Diseases

Infections

Symptoms and General Pathology

Carcinoma

Carcinoma, Hepatocellular

Hepatitis A

Hepatitis C

Hepatitis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Liver Diseases

Gastrointestinal Diseases

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Communicable Diseases

Blood-Borne Infections

Hepatitis, Viral, Human

Virus Diseases

Flaviviridae Infections

RNA Virus Infections

Anti-Infective Agents

All Drugs and Chemicals

Sofosbuvir

Ribavirin

Antimetabolites

Antiviral Agents

Patients taking Sofosbuvir and Daclatasvir

Patients taking Sofosbuvir,Daclatasvir, and Ribavirin

No intervention made this is an observational study to monitor the already existing protocols of the facility

Sofosbuvir 400 mg, Daclatasvir, Ribavirin

Nagwa A Sabri, Professor

Abd El Rahman El Naggar, Professor

Hasan A El Garem, Professor

Aya M Esawy, Assistant Lecturer

Sara M Zaki, Lecturer

May I Mehrez, Fellow

To evaluate the early detection of HCC in patients Taking Sofosbuvir and Daclatasvir.

Methodology:

Design:

Prospective, randomized study used to detect early incidence of HCC in patients taking Sofosbuvir and Daclatasvir to treat HCV.

Patients will be recruited from the National Hepatology and Tropical Medicine Research Institute (NHTMRI)

Duration of study:

24 weeks from starting the DAAs

Methods:

Patients will go through examination and lab. Workup three times in this study:

* FIRST time:

  * Before starting antiviral therapy, all included patients will undergo through physical examination, lab workup including HCV-RNA quantitative, fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, Pregnancy test ( Ladies in child bearing period), AFP as a marker of HCC.
  * Included patients will also undergo through diagnostic procedures as Abdominal ultrasonography and ECG (men \>40, women\>50).
* Second time:

  * At the end of antiviral therapy (12 weeks), virological response to therapy will be assessed by quantitative HCV RNA detection, using PCR.
  * Patients will lab workup including , fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, AFP as a marker of HCC.
  * The abdominal ultrasonography will be repeated any suspected focal lesion of the liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or the recurrence of HCC.
* Third and last time:

  * At 24 weeks ( Patients will be off treatment for the previous 12 weeks) , virological response to therapy will be assessed by quantitative HCV RNA detection, using PCR.
  * Patients will lab workup including, fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, AFP as a marker of HCC.
  * The abdominal ultrasonography will be repeated any suspected focal lesion of the liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or the recurrence of HCC.

Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir

MTI University

Assistant Lecturer

Rare Diseases

Hepatitis, Chronic

Hepatitis C, Chronic

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Antineoplastic Agents

Bevacizumab

Atezolizumab

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

Velpatasvir

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

Participants will receive bevacizumab and atezolizumab about every 3 weeks as part of the standard of care HCC treatment that is managed by your cancer doctor. In addition, Participants will continue receiving your standard of care DAAs (either sofosbuvir + velpatasvir or sofosbuvir + velpatasvir + voxilaprevir)

Voxilaprevir

Harrys A Torres, MD

Harrys A. Torres, MD

To learn if giving immune checkpoint therapy (such as atezolizumab) and bevacizumab to patients who have HCC and are receiving DAAs may help to control HCC and hepatitis C.

Primary Objective(s):

* Estimate the objective response rate (ORR) to ICT and estimate the sustained virologic response (SVR) in patients with HCC and chronic HCV infection using HCV clearance with DAA therapy.
* Estimate the change of the overall T cells and virus-specific T cells before and after the antiviral treatment in patients with HCC and chronic HCV infection using HCV clearance with DAA therapy.

Secondary objective:

--Collect the safety profile of the treatment and estimate the time-to-event variable such as overall survival (OS) and progression free survival (PFS).

Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Recurrence

Enterovirus Infections

Picornaviridae Infections

Sofosbuvir plus ribavirin for up to 48 weeks or until time of transplant, whichever occurs first.

Sofosbuvir 400 mg (2 x 200 mg tablets) administered orally once daily

Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Jill Denning, MA

The primary objective is to determine if the administration of a combination of sofosbuvir (SOF; GS-7977; PSI-7977) and ribavirin (RBV) to HCV-infected adults with hepatocellular carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation could prevent post-transplant re-infection as determined by a sustained post-transplant virological response (HCV RNA \< LLoQ) at 12 weeks post-transplant.

Participants will enroll in the pretransplant treatment phase (24 or 48 weeks). Participants enrolling for 24 weeks in the pretransplant treatment phase may receive treatment for up to an additional 24 weeks in the pretransplant retreatment phase. Participants enrolling for 48 weeks in the pretransplant treatment will have a second baseline at Week 24 for combined analysis in the pretransplant retreatment phase.

Participants who undergo liver transplant will stop all study drug 24 hours prior to transplant, and enter a 48-week follow-up phase to monitor for recurrent HCV infection.

Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant

An Open-Label Study to Explore the Clinical Efficacy of GS-7977 With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant

pTVR was defined as HCV RNA \< the lower limit of quantification (LLOQ, ie, 25 mL/IU) at Week 12 after transplant.

* Treatment-emergent deaths were those that occurred while taking study drug or to the minimum of 1) date of transplantation, 2) retreatment 1st dose date, or 3) last dose date + 30 days.
* Only those participants who underwent liver transplantation were analyzed for death post-transplantation.

pTVR was defined as HCV RNA \< the lower limit of quantification (LLOQ, ie, 25 mL/IU) at the relevant time point after transplant.

Virologic failure (VF) in the pretransplant phase was defined by:

* Breakthrough (HCV RNA ≥ 25 IU/ml after having previously had HCV RNA \< 25 IU/ml, while on treatment)
* Rebound (breakthrough or \> 1 log10 IU/ml increase in HCV RNA from nadir while on treatment)
* Non-response (HCV RNA ≥ 25 IU/ml through 8 weeks of treatment)
* Pre-transplant relapse (HCV RNA ≥ 25 IU/ml during the Pre-Transplant off-treatment follow-up period after having achieved HCV RNA \< 25 IU/ml at last observed HCV RNA on treatment)

Gilead Sciences

SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.

SOF+RBV

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black or African American

Race/Ethnicity, Customized

United States

Spain

New Zealand

Region of Enrollment

Prior Hepatitis C Virus (HCV) Treatment

Non-Responder: Null

Non-Responder: Partial

Responder: Breakthrough

Responder: Relapser

Unknown

Had Not Received Prior Treatment

Response to Last Prior HCV Treatment Regimen

Days on Transplant Waitlist

Baseline HCV RNA

< 6 log10 IU/mL

≥ 6 and < 7 log10 IU/mL

≥ 7 log10 IU/mL

Baseline HCV RNA Category

Genotype 1a

Genotype 1b

Genotype 2a

Genotype 2b

Genotype 3a

Genotype 4a

There are variations of HCV which are all similar enough to be called HCV, but are distinct enough to be referred to as HCV genotypes.

HCV Genotype

Missing

CC, CT, and TT alleles are different forms of the IL28b gene.

IL28b Status

CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.

Baseline Child-Pugh Turcotte (CPT) Score

MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.

Baseline Model For End-Stage Liver Disease (MELD) Score

Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug

Clinical Trial Disclosures

Transplant after ≥ 12 weeks of treatment (N=32)

Transplant after any duration of treatment (N=43)

Participants in the Full Analysis Set (enrolled and received at least 1 dose of study drug) who underwent liver transplantation, and who had HCV RNA \< LLOQ at last measurement prior to transplant were analyzed.

Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12

Percentage of Participants Experiencing Any Adverse Event Leading to Permanent Discontinuation of Sofosbuvir Prior to Receiving Transplant

Participants in the Safety Analysis Set who underwent liver transplantation were analyzed.

Percentage of Participants With Graft Loss Following Transplant

Posttransplant Week 1 (N = 32)

Posttransplant Week 2 (N = 32)

Posttransplant Week 4 (N = 32)

Posttransplant Week 8 (N = 32)

Posttransplant Week 24 (N = 32)

Posttransplant Week 48 (N = 30)

Participants in the Full Analysis Set who underwent liver transplantation and who had ≥ 12 weeks treatment and HCV RNA \< LLOQ at last measurement prior to transplant were analyzed.

Percentage of Participants With Posttransplant Virologic Response (pTVR) Through Posttransplant Week 48

Week 1 (N = 61)

Week 2 (N = 61)

Week 3 (N = 60)

Week 4 (N = 58)

Week 8 (N = 54)

Week 12 (N = 48)

Week 24 (N = 30)

Week 36 (N = 9)

Week 48 (N = 8)

Participants in the Full Analysis Set with available data were analyzed.

Percentage of Participants With HCV RNA < LLOQ (ie, 25 mL/IU) During Treatment Through Week 48

Week 1 (N = 59)

Week 8 (N = 53)

HCV RNA and Change From Baseline in HCV RNA Through Week 8

On-treatment VF (N = 61)

Posttreatment/Pretransplant VF - 24 Weeks (N = 15)

Posttreatment/Pretransplant VF - 48 Weeks (N = 8)

On-treatment VF: Full Analysis Set. Posttreatment/Pretransplant VF - 24 Weeks or 48 Weeks: Participants who completed 24 or 48 weeks of treatment and had an observed or imputed Week 4 posttreatment follow-up HCV RNA value relapsed during posttreatment follow-up were analyzed.

Proportion of Participants With Virologic Failure Prior to Transplant

All Deaths

Treatment-Emergent Death (N = 61)

Death Following Transplant (N = 46)

Death Not Meeting Either Criteria (N = 61)

Number of Participants Who Died

Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir	NCT03247296	Hepatitis C	Sofosbuvir 400 ...	18 Years - 75 Years	MTI University
Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir	NCT03247296	Hepatitis C	Sofosbuvir 400 ...	18 Years - 75 Years	MTI University
Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy	NCT05717400	Liver Cancer	Bevacizumab Atezolizumab Sofosbuvir Velpatasvir Voxilaprevir Ribavirin	18 Years -	M.D. Anderson Cancer Center
Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant	NCT01559844	Hepatitis C Hepatocellular ...	Sofosbuvir Ribavirin	18 Years -	Gilead Sciences
Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant	NCT01559844	Hepatitis C Hepatocellular ...	Sofosbuvir Ribavirin	18 Years -	Gilead Sciences

Spots Global Cancer Trial Database for sofosbuvir

Every month we try and update this database with for sofosbuvir cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sofosbuvir

Every month we try and update this database with for sofosbuvir cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sofosbuvir cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.