Treatment of chronic hepatitis C genotype 3 with Sofosbuvir-based therpy: a real-life study

Sidhu, Sandeep Singh; Malhi, Nirmaljeet Singh; Singh, Rupinder; Dutta, Usha; Grover, Rajiv; Sidhu, Js; Nanda, Vijay; Saluja, Harmeet; Bansal, Ajesh; Singh, Gaganpreet; Sehgal, Alok; Kishore, Harsh; Simran, Sidhu

doi:10.1007/s12072-017-9794-1

Cited by 5 publications

(4 citation statements)

References 23 publications

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“…We previously reported an SVR (24 weeks) rate of 64% in patients treated with peginterferon and ribavirin in combination . In this present study, overall SVR12 was 95.9% (470/490), which is similar to those reported previously from other studies performed in the Indian subcontinent . Prior multicenter studies evaluating the efficacy of branded DAA have reported similar high SVR12 rates .…”

Section: Discussionsupporting

confidence: 91%

“…15 In this present study, overall SVR12 was 95.9% (470/490), which is similar to those reported previously from other studies performed in the Indian subcontinent. [16][17][18] Prior multicenter studies evaluating the efficacy of branded DAA have reported similar high SVR12 rates. [5][6][7]19 Our study supports the fact that generic DAAs are associated with high efficacy.…”

Section: Adverse Eventsmentioning

confidence: 93%

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Efficacy of generic oral directly acting agents in patients with hepatitis C virus infection

Gupta

Rout

Patel

et al. 2018

Journal of Viral Hepatitis

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Novel direct-acting antivirals (DAAs) are now the standard of care for the management of hepatitis C virus (HCV) infection. Branded DAAs are associated with high sustained virological response at 12 weeks post-completion of therapy (SVR12), but are costly. We aimed to assess the efficacy of generic oral DAAs in a real-life clinical scenario. Consecutive patients with known HCV infection who were treated with generic-oral DAA regimens (May 2015 to January 2017) were included. Demographic details, prior therapy and SVR12 were documented. Four hundred and ninety patients (mean age: 38.9 ± 12.7 years) were treated with generic DAAs in the study time period. Their clinical presentations included chronic hepatitis (CHC) in 339 (69.2%) of cases, compensated cirrhosis in 120 (24.48%) cases and decompensated cirrhosis in 31 (6.32%) cases. Genotype 3 was most common (n = 372, 75.9%) followed by genotype 1 (n = 97, 19.8%). Treatment naïve and treatment-experienced (defined as having previous treatment with peginterferon and ribavirin) were 432 (88.2%) and 58 (11.8%), respectively. Generic DAA treatment regimens included sofosbuvir in combination with ribavirin (n = 175), daclatasvir alone (n = 149), ribavirin and peginterferon (n = 80), ledipasvir alone (n = 43), daclatasvir and ribavirin (n = 37), and ledipasvir and ribavirin (n = 6). Overall SVR12 was 95.9% (470/490) for all treatment regimens. SVR12 for treatment naïve and experienced patients was 97.0% (419/432) and 87.9% (51/58), respectively, P = .005. High SVR12 was observed with various regimens, irrespective of genotype and underlying liver disease status. There were no differences in SVR12 with 12 or 24 weeks therapy. No major adverse event occurred requiring treatment stoppage. Generic oral DAAs are associated with high SVR rates in patients with HCV infection in a real-life clinical scenario.

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Section: Discussionsupporting

confidence: 91%

Section: Adverse Eventsmentioning

confidence: 93%

Efficacy of generic oral directly acting agents in patients with hepatitis C virus infection

Gupta

Rout

Patel

et al. 2018

Journal of Viral Hepatitis

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“…For patients treated with 24 weeks of SOF+RBV, AE data were available in 1346 patients from two studies. 36 38 The most common AEs were anaemia (28.1%, 95% CI 25.2% to 31.2%), headache (23.5%, 95% CI 14.5% to 35.8%), fatigue (22.9%, 95% CI 13.1% to 37.1%), myalgia (11.0%, 95% CI 8.6% to 14.1%), and insomnia (7.8%, 95% CI 5.2% to 11.5%).…”

Section: Resultsmentioning

confidence: 99%

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

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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.

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“…The price of treatment remains a major barrier to curing hepatitis C for millions of people, and where rationing of treatment, lack of health insurance or lack of a national treatment program deny access to these drugs, people are turning to internet-based community portals or 'buyer's clubs' to obtain generic versions of direct-acting antivirals. [20][21][22][23] Freeman et al 23 showed very high cure rates when using…”

Section: Cost Evaluation Of Daasmentioning

confidence: 99%

Chronic Hepatitis C: Do Generics Work as Well as Branded Drugs?

Premkumar

Grover²,

Dhiman

2017

Journal of Clinical and Experimental Hepatology

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India has a large share of the hepatitis C virus (HCV) burden of the world. Unsafe medical practices and blood transfusions are the leading modes of transmission of HCV in India. The commonest HCV genotype in India is genotype 3 followed by genotype 1. While directly acting antivirals (DAAs) agents have become available at reasonable rates in India, cost of therapy remains a major barrier for control of HCV in India. Generic DAAs have been proven to be cost-saving in prior studies. We examined data from various studies in India and elsewhere using generic DAAs, and evaluated whether they are equally efficacious as the branded drugs. Since the availability of generic DAAs in the Indian market, there is a lot of real life data as well as prospective studies in special patient populations such as hematological disorders (thalassemia and hemophilia), chronic kidney disease, hemodialysis patients, post liver and renal transplant patients on immunosuppression, intravenous drug users, confections and other high risk groups. Control of HCV infection in India requires multi pronged approach. There is a need to formulate a health educational curriculum targeting not only the high-risk population but also the general population regarding the transmission of HCV. Adopting the dual approach of treating the old cases (decreasing the reservoir pool of HCV) and decreasing the incidence of new ones would help curtail the disease and decrease liver related mortality. In this scenario, the role of efficacious low cost generic medications is essential.

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Treatment of chronic hepatitis C genotype 3 with Sofosbuvir-based therpy: a real-life study

Abstract: Both dual and triple therapy regimes resulted in SVR rates of >95% in CHC genotype 3 who were naive non-cirrhotics. However, the SVR rates were low in treatment-experienced cirrhotics.

Cited by 5 publications

References 23 publications

Efficacy of generic oral directly acting agents in patients with hepatitis C virus infection

Efficacy of generic oral directly acting agents in patients with hepatitis C virus infection

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

Chronic Hepatitis C: Do Generics Work as Well as Branded Drugs?

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