Sofosbuvir-velpatasvir single-tablet regimen administered for 12 weeks in a phase 3 study with minimal monitoring in India

Hepatology International
A SoodVivek Saraswat

Abstract

In clinical studies, sofosbuvir-velpatasvir has demonstrated high cure rates and favorable tolerability in patients chronically infected with chronic hepatitis C virus (HCV) of any genotype. We evaluated the effectiveness and safety of sofosbuvir-velpatasvir administered with minimal medical monitoring to patients in India. At 16 sites in India, 129 adult patients with chronic HCV infection of any genotype initiated 12 weeks of once-daily sofosbuvir-velpatasvir (400-100 mg). Patients with compensated cirrhosis or prior treatment experience could be included in the study. Study drug was dispensed monthly, but there were no on-treatment study assessments. The primary efficacy endpoint was rate of sustained virologic response (HCV RNA < 15 IU/mL) 12 weeks after treatment (SVR12), which was compared to a pre-specified performance goal of 85%. The majority of patients had HCV genotype 3 infection (70%), followed by HCV genotype 1 (22%). The SVR12 rate was 93% (120/129; 95% CI, 87% to 97%) (p = 0.009 compared with the 85% performance goal). Of the nine patients who did not achieve SVR12, 1 experienced virologic failure, 2 relapsed after treatment, 1 withdrew consent after treatment, and 5 were lost to follow-up (1 during and 4 after ...Continue Reading

References

Apr 2, 2003·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Abhijit ChowdhuryDebendra Nath Guha Mazumder
Jul 2, 2005·Infection, Genetics and Evolution : Journal of Molecular Epidemiology and Evolutionary Genetics in Infectious Diseases·Mohammed N KhajaRamareddy V Guntaka
Apr 2, 2009·Journal of Gastroenterology and Hepatology·Ming-Lung Yu, Wan-Long Chuang
Oct 18, 2012·Indian Journal of Gastroenterology : Official Journal of the Indian Society of Gastroenterology·Ajit SoodManu Bansal
Nov 28, 2012·North American Journal of Medical Sciences·Sandeep Sachdeva, Bharti Mehta
Oct 25, 2013·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Nicolas Goossens, Francesco Negro
Aug 3, 2014·Journal of Hepatology·Erin GowerHomie Razavi
Dec 1, 2013·Journal of Clinical and Experimental Hepatology·Arikichenin Olithselvan, Mohamed Rela
Nov 17, 2015·The New England Journal of Medicine·Jordan J FeldUNKNOWN ASTRAL-1 Investigators
Nov 18, 2015·The New England Journal of Medicine·Graham R FosterUNKNOWN ASTRAL-3 Investigators
Nov 18, 2015·World Journal of Gastroenterology : WJG·Claire GondeauDominique Larrey
Jan 1, 2014·Therapeutic Innovation & Regulatory Science·Brian L WiensScott M Berry

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Citations

Oct 11, 2020·Transplant Infectious Disease : an Official Journal of the Transplantation Society·Sarita Rani JaiswalSuparno Chakrabarti
Oct 3, 2020·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Chen-Hua Liu, Jia-Horng Kao
May 2, 2020·Journal of the Formosan Medical Association = Taiwan Yi Zhi·Ming-Lung YuWan-Long Chuang
Oct 8, 2020·Liver International : Official Journal of the International Association for the Study of the Liver·Sunil TanejaHarbir S Kohli
Jul 31, 2021·World Journal of Gastroenterology : WJG·Fátima Higuera-de la TijeraLuis Servín-Abad

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