Efficacy and safety of generic daclatasvir + sofosbuvir ± ribavirin in treatment of genotype 3 infected hepatitis C patients - a real life experience from Pakistan

Umar, Muhammad; Akhter, Tayyab Saeed; Sadiq, Junaid; Saleem, Sajid; Khokhar, Shoaib

doi:10.20517/2394-5079.2018.31

Cited by 6 publications

(9 citation statements)

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“…In the current study, treatment‐naive patients treated with DCV + SOF achieved higher SVR12 (99%) as compared with pretreated patients (90%) of GT3. This is in line with the results published by Nelson et al 28 where SVR12 rates were 90% in treatment‐naive and 86% in pretreated patients and SVR12 was 84% and 80% in treatment‐naive and pretreated patients, respectively, in a study by Umar et al 33 Similarly, in our study, cirrhotic patients treated with DCV + SOF achieved (92% SVR12) as compared with non‐cirrhotic patients (98% SVR12). In compliance with our study findings, SVR12 rates greater than 90% in cirrhotic patients was reported in respective studies conducted elsewhere 22,27‐29,31,34 .…”

Section: Discussionsupporting

confidence: 93%

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Direct‐acting antiviral agents in the treatment of chronic hepatitis C—Real‐life experience from clinical practices in Pakistan

Mushtaq

Mansoor

Umar

et al. 2020

Journal of Medical Virology

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This study aims to evaluate the clinical effectiveness in terms of sustained virological response (SVR), predictors of SVR and safety of available second‐generation generic direct‐acting antivirals in Pakistani chronic hepatitis C patients. This is a retrospective study conducted in multiple centers of Pakistan from January 2015 to January 2019. The samples include patients infected with chronic hepatitis C virus, regardless of virus genotype, cirrhosis, or prior treatment. A total of 993 patients were included in the present study, with the majority receiving sofosbuvir with daclatasvir (95%), sofosbuvir with daclatasvir and ribavirin (4%), and sofosbuvir with ribavirin (1%). There were 96% cases of chronic hepatitis, 3% cases compensated cirrhosis, and 1% cases of decompensated cirrhosis. Genotype 3 (99.6%) was the most common genotype. Overall SVR after 12 weeks was 98% for all treatment regimens. High SVR12 was observed with sofosbuvir in combination with daclatasvir (98.5%), then sofosbuvir in combination with daclatasvir and ribavirin (90.2%) and sofosbuvir in combination with ribavirin (75%). SVR rates were high in chronic hepatitis C patients (98.2%) as compared with cirrhotic patients (92.1%) and it was high in treatment‐naive (98.8%) then interferon experienced patients (90.1%). In multivariate binary logistic regression analysis, patients’ education status, treatment strategy, viral load, and alanine aminotransferase had a statistically significant association with SVR at 12 weeks. No major adverse events occurred which required treatment discontinuation. Generic oral direct acting antiviralss (sofosbuvir with daclatasvir) achieved higher SVR12 rates and were well tolerated in this large real‐world cohort of genotype 3 infected patients.

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Section: Discussionsupporting

confidence: 93%

“…A study from Egypt reported a skin rash up to 9.8% of the patients using generic sofosbuvir and daclatasvir 20 . Oral ulcers have been found 8.8% with this combination in Pakistani population 33 …”

Section: Discussionmentioning

confidence: 99%

Direct‐acting antiviral agents in the treatment of chronic hepatitis C—Real‐life experience from clinical practices in Pakistan

Mushtaq

Mansoor

Umar

et al. 2020

Journal of Medical Virology

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“…The most common AEs were skin rash and oral ulcers which is comparable with our previous study findings where skin rash and oral ulcers were among major side effects ( Mushtaq et al, 2020 ). A study from Egypt reported skin rash and Pakistan reported oral ulcers using generic SOF+DCV ( Hill et al, 2016 ; Umar et al, 2018 ). However, no study reported so far, the skin rash and oral ulcers by the use of generic SOF/VEL.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Generic Sofosbuvir Plus Daclatasvir and Sofosbuvir/Velpatasvir in HCV Genotype 3-Infected Patients: Real-World Outcomes From Pakistan

et al. 2020

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Background Direct-acting antivirals (DAAs) therapeutic regimens are highly effective against chronic hepatitis C virus (HCV) infection. However, HCV patients with genotype 3 (GT3) respond in a suboptimal way. This study aims to identify which of the DAAs-based therapeutic regimens are the best option for GT3. Methods Multiple governments and private tertiary care hospitals were involved in this real-life study of HCV-GT3 patients treated with DAAs. The efficacy and safety of generic sofosbuvir+daclatasvir±ribavirin (SOF+DCV±RBV) and sofosbuvir/velpatasvir±ribavirin (SOF/VEL±RBV) were assessed under the National Hepatitis C Program of Pakistan. Results Out of 1,388 participants, 70% of patients received SOF+DCV in government tertiary care hospitals and 30% received SOF/VEL in private tertiary care hospitals. The overall sustained virological responses (SVR) was 95.5%. The SVR rates at 12 weeks were comparable between SOF+DCV (94.4%) and SOF/VEL (94.7%) in chronic HCV patients. However, The SVR rates at 24 weeks were high in cirrhotic patients treated with SOF/VEL+RBV (88%) then SOF+DCV+RBV (83%). Non-responders were high in SOF-DCV than SOF-VEL (4.1 vs 3.8%, P = 0.05) regimen. In multivariate models, the significant predictors of non-SVR were age >60 years (odds ratio [OR] 4.46; 95% CI, 2.35–8.46, P = <0.001) and cirrhosis (OR 53.91; 95% CI, 26.49–109.6, P = <0.001). Skin rash (51 vs 44%) and oral ulcers (45 vs 40%) were high in patients receiving SOF-DCV then SOF-VEL. Conclusions Overall, the generic SOF+DCV ±RBV and SOF/VEL ± RBV achieved equally high SVR12 rates. However, SOF/VEL+RBV achieved a high SVR rate in cirrhotic patients then SOF+DCV+RBV. Old age and cirrhosis were significant predictors of reduced odds of SVR regardless of the regimen. Furthermore, the regimens were well tolerated in chronic HCV patients.

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“…12,13 In a study by Umar et al SVR was achieved in 83%. 14 In 2018, a study by Abozeid M et al showed SVR achieved in 98%. 15 Overall ETR in our study was achieved by 97.33% of the patients, however overall SVR rate was at 88.33%.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of Sofosbuvir and Daclatasvir in treatment of Hepatitis-C: An experience of tertiary care hospital in Karachi

Butt¹,

Saleem

Khan³

et al. 2021

Pak J Med Sci

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Objective: To assess the effectiveness of Sofosbuvir (SOF) and Daclatasvir (DCV) in patients with chronic hepatitis C (CHC), compensated cirrhosis (CC) and decompensated cirrhosis (DCLD) either treatment naïve or experienced. Methods: This was a prospective, observational study, conducted from January 2017 to December 2018 at Jinnah Postgraduate Medical Centre, Karachi. All patients above 12 years of age with detectable HCV RNA PCR were included. Patients were divided into three groups: CHC, CC and DCLD. SOF and DCV for 12 or 24 weeks were given. Ribavirin (RBV) was given to treatment experienced and cirrhotic patients. Primary outcome was End of Treatment Response (ETR) and secondary outcome was Sustained Virological Response (SVR) at post treatment week 12 or 24. Results: Total 300 patients with mean age of 40.49 ± 13.86 were enrolled. Majority were females 174 (58%). CHC were 200 (66.6%) while cirrhotic were 100 (33.4%). Treatment naïve patients were 267 (89%) and 33 (11%) patients were experienced. Most common genotype was 3 (83%). ETR was achieved in 292 (97.33%) and SVR in 265 (88.33%) patients respectively. Conclusion: SOF plus DCV with or without RBV is a highly effective treatment for chronic HCV and is still used in many centers of Pakistan. This regimen has excellent results for GT-3. The outcomes are mainly influenced by the presence or absence of cirrhosis. doi: https://doi.org/10.12669/pjms.37.7.4627 How to cite this:Butt N, Anoshia, Khan MA, Akbar A. Effectiveness of Sofosbuvir and Daclatasvir in treatment of Hepatitis-C: An experience of tertiary care hospital in Karachi. Pak J Med Sci. 2021;37(7):2014-2019. doi: https://doi.org/10.12669/pjms.37.7.4627 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Efficacy and safety of generic daclatasvir + sofosbuvir ± ribavirin in treatment of genotype 3 infected hepatitis C patients - a real life experience from Pakistan

Cited by 6 publications

References 0 publications

Direct‐acting antiviral agents in the treatment of chronic hepatitis C—Real‐life experience from clinical practices in Pakistan

Direct‐acting antiviral agents in the treatment of chronic hepatitis C—Real‐life experience from clinical practices in Pakistan

Efficacy and Safety of Generic Sofosbuvir Plus Daclatasvir and Sofosbuvir/Velpatasvir in HCV Genotype 3-Infected Patients: Real-World Outcomes From Pakistan

Effectiveness of Sofosbuvir and Daclatasvir in treatment of Hepatitis-C: An experience of tertiary care hospital in Karachi

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