scholarly journals Novel combined single dose anti-hepatitis C therapy: a pilot study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Gamal Shiha ◽  
Reham Soliman ◽  
Mohamed Elbasiony ◽  
Noureldien H. E. Darwish ◽  
Shaker A. Mousa
Keyword(s):  
Viral Load ◽  
Hepatitis C ◽  
Virologic Response ◽  
Fixed Dose ◽  
The Novel ◽  
Open Label ◽  
Genotype 4 ◽  
Treatment Regimens ◽  
Treatment Naïve ◽  
To Receive

AbstractThe new anti-hepatitis C virus (HCV) molecules improve treatment regimens and outcomes, but there are drawbacks. New combinations should target the HCV infectious cycle and be effective against all HCV genotypes. We developed the novel formulation Catvira, composed of epigallocatechingallate (EGCG) + sofosbuvir + ribavirin. Here, we compared Catvira to sofosbuvir + ribavirin tablets in patients with CHC genotype 4 in a randomized open-label efficacy and safety study. Treatment-naïve and treatment-experienced patients (n = 80) were randomly assigned to receive a single daily fixed dose of Catvira or sofosbuvir + ribavirin for 12 or 24 weeks. Both Catvira and sofosbuvir + ribavirin yielded similar outcomes of viral load (p < 0.001). Patients receiving Catvira had a significantly more rapid rate of viral load decline with sustained virologic response (SVR12) achieved by 90% of patients receiving 12 weeks of treatment. Catvira did not impact hemoglobin levels while sofosbuvir + ribavirin showed significant decline in hemoglobin levels after 24 weeks (p < 0.05). In this clinical trial (ClinicalTrials.gov Identifier NCT02483156), we found that Catvira administered daily for 12 or 24 weeks is safe, effective, and well-tolerated in both naïve and treatment-experienced patients with HCV genotype 4.

scholarly journals Efficacy of sofosbuvir in the treatment-naïve patients infected with 3a genotype of Hepatitis C.

2021 ◽  
Vol 28 (01) ◽  
pp. 72-79
Author(s):  
Sarmad Zahoor ◽  
Samreen Hameed ◽  
Saroosh Zahoor ◽  
Hafiz Muhammad Sajid Jehangir ◽  
Samar Firdous ◽  
...  
Keyword(s):  
Experimental Study ◽  
Viral Load ◽  
Hepatitis C ◽  
Adverse Effects ◽  
Treatment Response ◽  
Study Design ◽  
Duration Of Treatment ◽  
Open Label ◽  
Treatment Naïve ◽  
Genotype 3A

Objectives: This study was conducted to test the efficacy of Sofosbuvir in patients of genotype 3a who are treatment-naïve which represents the most common setting in Pakistan. Study Design: Experimental study. Setting: Mayo Hospital, Lahore, Punjab, Pakistan. Period: August 2016 to September 2017. Material & Methods: We used an Open label and Quasi Experimental Study Design to test the efficacy of Sofosbuvir in 262 treatment-naïve patients. The duration of the therapy was 24 weeks. All patients were treated with Sofosbuvir 400mg once daily and Ribavirin 400 mg thrice daily. The end of treatment response i.e. ETR was noted at the end by determining the viral load by Polymerase Chain Reaction (PCR). Results: Of the 262 patients included in the study, 43 patients left the treatment either due to financial constraints barring them from following up or due to non-compliance. 11 patients left the treatment due to adverse events. 208 patients completed the 24-week therapy from which 201 (96.6 %) patients showed +Ve ETR. Two patients showed relapse both of whom had high viral load. Five patients were non-responders. The rate of discontinuation of Sofosbuvir due to adverse effects was low (4-5%). Conclusion: Patients with HCV genotype 3a have shown promising improvement in treatment response with Sofosbuvir as compared to the older treatment regimes. In contrast to the long duration of treatment and more disabling adverse effects profile of conventional regimes, Sofosbuvir, with its greater therapeutic efficacy and relatively well-tolerated adverse effects, is expected to provide a break-through in treating Hepatitis C and minimizing the incidence of its complications.

scholarly journals Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt

Gut ◽  
2018 ◽  
Vol 68 (4) ◽  
pp. 721-728 ◽  
Author(s):  
Gamal Shiha ◽  
Gamal Esmat ◽  
Mohamed Hassany ◽  
Reham Soliman ◽  
Mohamed Elbasiony ◽  
...  
Keyword(s):  
Previous Treatment ◽  
Phase Iii ◽  
Open Label ◽  
Genotype 4 ◽  
Hcv Genotype ◽  
Multicentre Phase ◽  
Highly Effective ◽  
Treatment Naïve ◽  
Phase Iii Study ◽  
To Receive

ObjectiveWe evaluated the efficacy and safety of ledipasvir/sofosbuvir alone and with ribavirin for 8 and 12 weeks in Egyptian patients with and without cirrhosis, who were infected with hepatitis C virus (HCV) genotype 4, including those who had failed previous treatment with sofosbuvir regimens.DesignIn this open-label, multicentre, phase III study, treatment-naive patients were randomised to receive 8 or 12 weeks of ledipasvir/sofosbuvir±ribavirin. Interferon treatment-experienced patients were randomised to receive 12 weeks of ledipasvir/sofosbuvir±ribavirin, while sofosbuvir-experienced or ledipasvir/sofosbuvir-experienced patients received 12 weeks of ledipasvir/sofosbuvir+ribavirin. Randomisation was stratified by cirrhosis status. The primary endpoint was sustained virological response 12 weeks post-treatment (SVR12).ResultsWe enrolled 255 patients from four centres in Egypt. Among treatment-naive patients, SVR12 rates were 95% and 90% for those receiving 8 weeks of ledipasvir/sofosbuvir alone and with ribavirin, respectively, and 98% for those receiving 12 weeks of ledipasvir/sofosbuvir both alone and with ribavirin. Among interferon-experienced patients, SVR rates were 94% for those receiving 12 weeks of ledipasvir/sofosbuvir and 100% for those receiving 12 weeks of ledipasvir/sofosbuvir plus ribavirin. All patients previously treated with sofosbuvir regimens who received ledipasvir/sofosbuvir plus ribavirin achieved SVR12. The most common adverse events, headache and fatigue, were more common among patients receiving ribavirin.ConclusionAmong non-cirrhotic treatment-naive patients with HCV genotype 4, 8 weeks of ledipasvir/sofosbuvir±ribavirin was highly effective. Twelve weeks of ledipasvir/sofosbuvir±ribavirin was highly effective regardless of presence of cirrhosis or prior treatment experience, including previous treatment with sofosbuvir or ledipasvir/sofosbuvir.Trial registration numberNCT02487030.

scholarly journals Pioglitazone Decreases Hepatitis C Viral Load in Overweight, Treatment Naïve, Genotype 4 Infected-Patients: A Pilot Study

PLoS ONE ◽  
2012 ◽  
Vol 7 (3) ◽  
pp. e31516 ◽  
Author(s):  
Mario Chojkier ◽  
Hisham Elkhayat ◽  
Dina Sabry ◽  
Michael Donohue ◽  
Martina Buck
Keyword(s):  
Viral Load ◽  
Hepatitis C ◽  
Pilot Study ◽  
Genotype 4 ◽  
Treatment Naïve

scholarly journals Wirelessly Observed Therapy to Optimize Adherence and Target Interventions for Oral Hepatitis C Treatment: Observational Pilot Study

10.2196/15532 ◽  
2020 ◽  
Vol 22 (2) ◽  
pp. e15532 ◽  
Author(s):  
Maurizio Bonacini ◽  
Yoona Kim ◽  
Caroline Pitney ◽  
Lee McKoin ◽  
Melody Tran ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Pilot Study ◽  
Sustained Virologic Response ◽  
Virologic Response ◽  
Hcv Infection ◽  
Fixed Dose ◽  
Adherence Rate ◽  
Open Label ◽  
Medication Therapy ◽  
Digital Medicine

Background A fixed-dose combination of ledipasvir/sofosbuvir (LDV/SOF) is efficacious in treating chronic hepatitis C virus (HCV) infection; however, objective adherence to prescribed regimens in real-world clinical settings has not been well studied. Objective This study aimed to evaluate adherence and virologic outcomes in patients with chronic HCV infection treated with LDV/SOF using a novel digital medicine program that directly measures drug ingestion adherence. Methods This prospective, observational, open-label, single-arm pilot study was conducted at 2 clinical research sites and followed patients with HCV infection who were prescribed LDV/SOF along with an ingestible sensor. Patients were treated for 8 or 12 weeks. The main outcomes were ingestion adherence, medical interventions, virologic response, safety, and patient satisfaction. Results Of the 28 patients (mean 59 years, SD 7), 61% (17/28) were male, 61% (17/28) were non-Caucasian, and 93% (26/28) were treatment naïve. All 28 had genotype 1 HCV, and of these, 27 completed an 8- or 12-week treatment. Patients used the digital medicine program for 92% of the expected days; the overall mean ingestion adherence rate was 97%. Providers used the digital medicine program data for same-day medication therapy management in 39% (11/28) of patients. End-of-treatment response was achieved in all the available 21 of 28 patients. Sustained virologic response at 12 weeks or more was achieved in 26 of 28 patients; of the 2 patients who relapsed, one had less than 90% adherence and the other had greater than or equal to 95% adherence, lending insights into reasons for treatment failure. A total of 4 subjects reported nonserious adverse events, which were resolved. Conclusions Conclusions: The findings of this study suggest that digital medicines can be used for wirelessly observed therapy to support adherence to antiviral HCV therapy, reduce unnecessary medication wastage and retreatment costs, and potentially optimize sustained virologic response rates, especially in populations at high risk for nonadherence.

scholarly journals Wirelessly Observed Therapy to Optimize Adherence and Target Interventions for Oral Hepatitis C Treatment: Observational Pilot Study (Preprint)

2019 ◽  
Author(s):  
Maurizio Bonacini ◽  
Yoona Kim ◽  
Caroline Pitney ◽  
Lee McKoin ◽  
Melody Tran ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Pilot Study ◽  
Sustained Virologic Response ◽  
Virologic Response ◽  
Hcv Infection ◽  
Fixed Dose ◽  
Adherence Rate ◽  
Open Label ◽  
Medication Therapy ◽  
Digital Medicine

BACKGROUND A fixed-dose combination of ledipasvir/sofosbuvir (LDV/SOF) is efficacious in treating chronic hepatitis C virus (HCV) infection; however, objective adherence to prescribed regimens in real-world clinical settings has not been well studied. OBJECTIVE This study aimed to evaluate adherence and virologic outcomes in patients with chronic HCV infection treated with LDV/SOF using a novel digital medicine program that directly measures drug ingestion adherence. METHODS This prospective, observational, open-label, single-arm pilot study was conducted at 2 clinical research sites and followed patients with HCV infection who were prescribed LDV/SOF along with an ingestible sensor. Patients were treated for 8 or 12 weeks. The main outcomes were ingestion adherence, medical interventions, virologic response, safety, and patient satisfaction. RESULTS Of the 28 patients (mean 59 years, SD 7), 61% (17/28) were male, 61% (17/28) were non-Caucasian, and 93% (26/28) were treatment naïve. All 28 had genotype 1 HCV, and of these, 27 completed an 8- or 12-week treatment. Patients used the digital medicine program for 92% of the expected days; the overall mean ingestion adherence rate was 97%. Providers used the digital medicine program data for same-day medication therapy management in 39% (11/28) of patients. End-of-treatment response was achieved in all the available 21 of 28 patients. Sustained virologic response at 12 weeks or more was achieved in 26 of 28 patients; of the 2 patients who relapsed, one had less than 90% adherence and the other had greater than or equal to 95% adherence, lending insights into reasons for treatment failure. A total of 4 subjects reported nonserious adverse events, which were resolved. CONCLUSIONS The findings of this study suggest that digital medicines can be used for wirelessly observed therapy to support adherence to antiviral HCV therapy, reduce unnecessary medication wastage and retreatment costs, and potentially optimize sustained virologic response rates, especially in populations at high risk for nonadherence.

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