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 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 interferon treated patients of hepatitis C infected with 3a genotype.

2019 ◽  
Vol 26 (10) ◽  
pp. 1606-1612
Author(s):  
Saroosh Zahoor ◽  
Sarmad Zahoor ◽  
Samreen Hameed ◽  
Syed Maaz Abdullah ◽  
Mohammad Sohail Afzal ◽  
...  
Keyword(s):  
Viral Load ◽  
Hepatitis C ◽  
Treatment Duration ◽  
Treatment Strategies ◽  
High Viral Load ◽  
Open Label ◽  
Mortality And Morbidity ◽  
Hcv Genotype ◽  
Quasi Experimental ◽  
Genotype 3A

Objectives: Hepatitis C is a blood borne infection primarily disrupting the functional and architectural integrity of liver and has a considerable share in worldwide mortality and morbidity. Treatment strategies against the causative RNA-based virus has widely evolved over time with newer Direct Acting Antivirals (DAA) being recently introduced. This study serves to assess the efficacy of Sofosbuvir (DAA) in patients of HCV genotype 3a with prior treatment with interferon. Study Design: An Open label, Prospective Quasi Experimental Study. Setting: Mayo Hospital, Lahore. Period: September 2016 to December 2017. Material and Methods: 212 patients with genotype 3a who had been previously treated with interferon (INF). They were treated with Sofosbuvir 400mg once daily and Ribavirin 400mg thrice daily. The treatment duration was 24 weeks following which the end of treatment response (ETR) was determined by quantifying viral load by Polymerase Chain Reaction (PCR). Results: Of the 212 patients enrolled, 50 patients did not give follow up either due to availability issues or due to non-compliance. 13 patients left the treatment due to comorbidities. 149 patients completed the treatment out of whom 131 patients showed positive response (87.9%). Nine patients with high viral load showed relapse while nine patients were non-responders. Conclusion: In interferon experienced patients of HCV genotype 3a, Sofosbuvir has shown to reach sublimecure rates which may serve to obviate conventional treatment strategies owing to their longer treatment duration and significant adverse effects. As demonstrated by this study, the modest safety profile coupled with an enhanced therapeutic efficacy of Sofosbuvir is expected to revolutionize treatment strategies against Hepatitis C limiting the spread and hence the incidence of disease.

scholarly journals Hepatitis C virus genotype 3a: Predictive factors associated with treatment response in patients of Peshawar.

2019 ◽  
Vol 26 (08) ◽  
pp. 1315-1322
Author(s):  
Amina Gul ◽  
Naheed Gul ◽  
Ijaz Ali ◽  
Jawad Ahmed
Keyword(s):  
Hepatitis C Virus ◽  
Viral Load ◽  
Hepatitis C ◽  
Treatment Response ◽  
Virological Response ◽  
Baseline Viral Load ◽  
P Value ◽  
Hcv Genotype ◽  
Chronic Hcv ◽  
Genotype 3A

Hepatitis C Virus (HCV) is a flavivirus responsible for causing chronic liver diseases including cirrhosis and hepatocellular carcinoma. Identification of various patient and virus-related factors that can help predict response to antiviral therapy is extremely important in formulating the best therapeutic strategy for each patient either to continue or stop the therapy. The present study aimed to determine Sustained Virological Response (SVR) in HCV genotype 3a infected patients that received combination therapy of Sofosbuvir and Ribavirin and to investigate various factors that can help predict SVR. Study Design: Longitudinal Study Settings: Institute of basic Medical Sciences, Khyber Medical University, Peshawar (IBMS, KMU). Period: July 2016 to September 2017. Materials and Methods: Treatment response was evaluated among 100 HCV genotype 3a infected patients that received Sofosbuvir and Ribavirin therapy for 24 weeks. Various baseline parameters including hematological, biochemical and viral profiles of were recorded. HCV genotype determination was carried out by type specific nested PCR based genotyping assay. Viral load was determined at baseline, at 12 weeks for Early Virological Response (EVR) and at 24 weeks of treatment for SVR. Viral RNA quantification was carried out by Real Time PCR. Results: Out of 100 patients, SVR was observed in 83% of patients; while 17% of the chronic HCV 3a infected patients were Non-Responders (NR). Mean age of patients was low 34 ± 9.8 among patients who achieved SVR as compared to patients with non-response (41 ± 10). The 24 weeks Alanine aminotransferase (ALT) levels were significantly lower among patients with SVR (p-value ≤ 0.05). Although statistically not significant, baseline viral load was higher in NR group (p-value ≥ 0.05), than those with SVR. Association of EVR with SVR was found statistically significant (OR= 2.8, 95% CI 1.2-6.4, p-value ≤ 0.05). Conclusions: The current study indicated that pre and on-treatment monitoring of patients receiving anti-viral therapy is important for the management of patients with chronic HCV infection. 

scholarly journals Response to combination of sofosbuvir and daclatasvir in chronic hepatitis C infection.

2020 ◽  
Vol 27 (12) ◽  
pp. 2596-2600
Author(s):  
Irfan Ahmad ◽  
Muhammad Israr ul Haq ◽  
Ghulam Abbas
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Treatment Response ◽  
Chronic Hepatitis C ◽  
Hepatitis C Infection ◽  
Open Label ◽  
College Hospital ◽  
End Of Treatment ◽  
Significant Difference ◽  
Chronic Hepatitis C Patients

Objectives: To determine efficacy of sofosbuvir and daclatasvir in the treatment of chronic hepatitis C infection. Study Design: Open label uncontrolled interventional study. Setting: Hepatitis Clinic, Sheikh Zayed Medical College/Hospital, Rahim Yar Khan. Period: June to December 2018. Material & Methods: Five hundred treatment naïve chronic hepatitis C patients including those with compensated cirrhosis were included in the study. They were given sofosbuvir 400 mg daily and daclatasvir 60 mg daily. Weight based ribavirin was added if patient has evidence of cirrhosis. Treatment duration was 12 weeks for non-cirrhotic and 24 weeks for cirrhotics. End of treatment response (ETR) was recorded. Results: Mean age of the included patients was 41±11.69 with range from 8 to 82 years, while 217 (43.4 %) patients were male and 283 (56.6 %) were female. Cirrhosis was present in 59 (11.8 %) patients; among these 35.6 % were in Child A and 64.4 % in early Child B. End of treatment response occurred in 491 (98.2 %) patients and there was no significant difference in ETR between male and female patients, and between cirrhotic and non-cirrhotic. Similarly, there was no significant difference in age between those having ETR and those having no ETR. Fatigue was experienced by 13.2 % and headache by 4.2 % patients. Conclusion: The combination of sofosbuvir and daclatasvir has high response rate in chronic hepatitis C patients of our population.

scholarly journals Naturally Occurring Resistance-Associated Variants of Hepatitis C Virus Protease Inhibitors in Poor Responders to Pegylated Interferon-Ribavirin

2015 ◽  
Vol 53 (7) ◽  
pp. 2195-2202 ◽  
Author(s):  
Sylvie Larrat ◽  
Sophie Vallet ◽  
Sandra David-Tchouda ◽  
Alban Caporossi ◽  
Jennifer Margier ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Viral Load ◽  
Hepatitis C ◽  
Triple Therapy ◽  
Pegylated Interferon ◽  
Poor Responders ◽  
Obvious Effect ◽  
Treatment Naïve ◽  
Detection Of Mutations ◽  
The Impact

The pretherapeutic presence of protease inhibitor (PI) resistance-associated variants (RAVs) has not been shown to be predictive of triple-therapy outcomes in treatment-naive patients. However, they may influence the outcome in patients with less effective pegylated interferon (pegIFN)-ribavirin (RBV) backbones. Using hepatitis C virus (HCV) population sequence analysis, we retrospectively investigated the prevalence of baseline nonstructural 3 (NS3) RAVs in a multicenter cohort of poor IFN-RBV responders (i.e., prior null responders or patients with a viral load decrease of <1 log IU/ml during the pegIFN-RBV lead-in phase). The impact of the presence of these RAVs on the outcome of triple therapy was studied. Among 282 patients, the prevalances (95% confidence intervals) of baseline RAVs ranged from 5.7% (3.3% to 9.0%) to 22.0% (17.3% to 27.3%), depending to the algorithm used. Among mutations conferring a >3-fold shift in 50% inhibitory concentration (IC50) for telaprevir or boceprevir, T54S was the most frequently detected mutation (3.9%), followed by A156T, R155K (0.7%), V36M, and V55A (0.35%). Mutations were more frequently found in patients infected with genotype 1a (7.5 to 23.6%) than 1b (3.3 to 19.8%) (P= 0.03). No other sociodemographic or viroclinical characteristic was significantly associated with a higher prevalence of RAVs. No obvious effect of baseline RAVs on viral load was observed. In this cohort of poor responders to IFN-RBV, no link was found with a sustained virological response to triple therapy, regardless of the algorithm used for the detection of mutations. Based on a cross-study comparison, baseline RAVs are not more frequent in poor IFN-RBV responders than in treatment-naive patients and, even in these difficult-to-treat patients, this study demonstrates no impact on treatment outcome, arguing against resistance analysis prior to treatment.

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