Efficacy and safety of sofosbuvir-based therapy for chronic hepatitis C infection in “real-life” cohort

Mehta, Rajiv; Kabrawala, Mayank; Nandwani, Subhash; Tekriwal, Rini; Nandaniya, Payal; Shah, Mrunal; Bhayani, Vishwa

doi:10.1007/s12664-016-0713-5

Cited by 6 publications

(8 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…We performed a stratified subgroup analysis by cirrhosis status and treatment history with 2581 DAA-treated patients with CHC GT3 in six studies. 31 32 34–36 38 We found that non-cirrhotic treatment-naïve patients had the highest SVR12 at 98.0% (n=1324, 95% CI 96.6% to 98.8%, I 2 =17.2%). Non-cirrhotic treatment-experienced patients also had relatively high SVR12 at 91.1% (n=927, 95% CI 47.8% to 99.1%, I 2 =94.8%).…”

Section: Resultsmentioning

confidence: 67%

Systematic review and meta-analysis: real-world effectiveness of direct-acting antiviral therapies in chronic hepatitis C genotype 3 in Asia

Wei

Yeo

et al. 2018

BMJ Open Gastroenterol

View full text Add to dashboard Cite

BackgroundGenotype 3 (GT3) is a common chronic hepatitis C (CHC) genotype in Asia. Direct-acting antiviral (DAA) regimens have high cure rates, but real-world results are limited for Asia.AimTo determine the real-world effectiveness of DAAs for patients with CHC GT3 in Asia.MethodsA systematic search was performed in PubMed (including MEDLINE), Embase, and selected international meeting abstract repositories. Eligible studies were postmarketing observational studies from Asia with the primary outcome of sustained virological response 12 weeks after completion of treatment (SVR12).ResultsA total of 15 studies with 4230 patients yielded a pooled SVR12 of 92.7%. High heterogeneity (I2=93.2%, P<0.0001) was noted. In subgroup analyses, patients with cirrhosis had 10.9% lower SVR12 than non-cirrhotic patients (88.6% vs 98.9%; P<0.0001) and contributed 69.5% of the heterogeneity. Prior treatment failure did not reduce the pooled SVR12 (treatment-naïve: 94.6%, 95% CI 91.3% to 96.7% vs treatment-experienced: 94.0%, 95% CI 77.5% to 98.6%; P=0.89). Twenty-four weeks of sofosbuvir+ribavirin dual therapy was the most commonly used regimen which led to similar SVR12 (OR=1.1, P=0.73) but lower adverse event rate than 12 weeks of sofosbuvir+ribavirin+pegylated interferon triple therapy.ConclusionSofosbuvir+ribavirin for 24 weeks is the most widely used and generally well-tolerated DAA therapy in Asia. However, its effectiveness is not optimal in GT3 patients with cirrhosis.

show abstract

Section: Resultsmentioning

confidence: 67%

Systematic review and meta-analysis: real-world effectiveness of direct-acting antiviral therapies in chronic hepatitis C genotype 3 in Asia

Wei

Yeo

et al. 2018

BMJ Open Gastroenterol

View full text Add to dashboard Cite

show abstract

“…5 Moreover, the safety and efficacy of SOF-containing regimens has been proved in real life settings enriched with more elderly, treatment-experienced patients as well as patients with advanced fibrosis stages. [6][7][8] However, to the date, there is scarcity of evidences demonstrating safety and efficacy of SOF-containing regimens in patients with b-thalassemia major. 9,10 Hence, this study was designed to evaluate safety and efficacy of combination regimen of SOF and Daclatasvir (DCV) for chronic HCV infection in patients with b-thalassemia major.…”

mentioning

confidence: 99%

Safety and Efficacy of Sofosbuvir and Daclatasvir for Hepatitis C Virus Infection in Patients with β-Thalassemia Major

Mehta

Kabrawala

Nandwani

et al. 2018

Journal of Clinical and Experimental Hepatology

Self Cite

View full text Add to dashboard Cite

show abstract

“…SVR appeared higher in our cohort of patients with cirrhosis compared to that reported in HCV-TARGET; however, the HCV-TARGET patients were predominantly white (82%) while our patients were all of Indian origin. Registrational studies of sofosbuvir in India recently reported high SVR rates among their patients with genotype 3 infection treated with sofosbuvir and ribavirin (over 90%) [ 24 , 25 ]. Furthermore, an observational study of 490 patients treated with generic formulas of sofosbuvir combined with either ribavirin with or without pegylated interferon, or generic daclatasvir or ledipasvir, for 12 or 24 weeks at single center in India was recently published.…”

Section: Discussionmentioning

confidence: 99%

Comparative Antiviral Efficacy of Generic Sofosbuvir versus Brand Name Sofosbuvir with Ribavirin for the Treatment of Hepatitis C

Tang

Kamat

Shukla

et al. 2018

Interdisciplinary Perspectives on Infectious Diseases

View full text Add to dashboard Cite

Background Chronic hepatitis C infection is a major cause for liver failure and liver cancer and can be treated with highly effective all oral directly acting antiviral (DAA) drugs. Generic versions of these DAAs are available in India. Method This was an open-label, single-center, prospective, nonrandomized observational study for the comparative safety and efficacy of generic versus brand name sofosbuvir with ribavirin therapy for chronic hepatitis C infection (all genotypes). Between December 2014 and December 2015, 66 patients received either generic sofosbuvir (400mg) or brand name SOLVALDI (400mg) with weight based ribavirin for 24 weeks in a single multispecialty hospital in Mumbai. Monitoring viral loads and safety labs was performed as per national guidelines. Results Sustained virologic response was 72.4% versus 75.7% (p=0.78) among patients treated with generics and SOVALDI, respectively. At 4 weeks on-treatment, approximately 90% of patients from both groups had undetectable or below the lower limit of quantification. Change in hemoglobin was comparable in both groups (p=0.26). Conclusion Generic versions of sofosbuvir reported in this study are safe and efficacious to treat hepatitis C. However, bioequivalency studies of all generic DAAs need to be performed before wider use of such drugs for the treatment of hepatitis C.

show abstract

Efficacy and safety of sofosbuvir-based therapy for chronic hepatitis C infection in “real-life” cohort

Abstract: Sofosbuvir-based treatment is safe and efficacious in clinical practice in Indian patients with HCV genotype-1 and genotype-3 infection.

Cited by 6 publications

References 19 publications

Systematic review and meta-analysis: real-world effectiveness of direct-acting antiviral therapies in chronic hepatitis C genotype 3 in Asia

Systematic review and meta-analysis: real-world effectiveness of direct-acting antiviral therapies in chronic hepatitis C genotype 3 in Asia

Safety and Efficacy of Sofosbuvir and Daclatasvir for Hepatitis C Virus Infection in Patients with β-Thalassemia Major

Comparative Antiviral Efficacy of Generic Sofosbuvir versus Brand Name Sofosbuvir with Ribavirin for the Treatment of Hepatitis C

Contact Info

Product

Resources

About