Trial reportHepatology international2019
Sofosbuvir-velpatasvir single-tablet regimen administered for 12 weeks in a phase 3 study with minimal monitoring in India.
Trial report in Hepatology international, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy of 12-weeks velpatasvir plus sofosbuvir-based regimen in HCV-naive subjects with mild fibrosis: a meta-analysis.Acta bio-medica : Atenei Parmensis · 2019Pooled it
- Reinfection and Resistance Associated Substitutions Following a Minimal Monitoring Approach for Hepatitis C Virus Treatment in MINMON Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- A minimal monitoring approach for the treatment of hepatitis C virus infection (ACTG A5360 [MINMON]): a phase 4, open-label, single-arm trial.The lancet. Gastroenterology & hepatology · 2022Trial
- TeleHCV: A single-visit protocol and minimal passive remote monitoring are sufficient to achieve high SVR with a sofosbuvir-velpatasvir regimen.Clinics (Sao Paulo, Brazil) · 2025Article
- Hepatitis C Virus Infection in the Elderly in the Era of Direct-Acting Antivirals: Evidence from Clinical Trials and Real Life.Tropical medicine and infectious disease · 2023Review
- Real-world impact of a subsidy decision of sofosbuvir-velpatasvir for treatment of chronic hepatitis C on clinical practice and patient outcomes.JGH open : an open access journal of gastroenterology and hepatology · 2023Article
- Rapid Treatment Initiation for Hepatitis C Virus Infection: Potential Benefits, Current Limitations, and Real-World Examples.Gastroenterology & hepatology · 2022Article
- Hepatitis C virus in India: Challenges and Successes.Clinical liver disease · 2021Review
- Progress and challenges in the comprehensive management of chronic viral hepatitis: Key ways to achieve the elimination.World journal of gastroenterology · 2021Review
- Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan.Hepatology international · 2021Article
- Guidelines Have a Key Role in Driving HCV Elimination by Advocating for Simple HCV Care Pathways.Advances in therapy · 2021Article
Corrections and comments
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Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsIn 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.
methodsAt 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%.
resultsThe 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 treatment). Sofosbuvir-velpatasvir was well-tolerated, and no patients discontinued treatment because of an adverse event. The most frequently reported adverse events were headache (3% of patients), upper abdominal pain (2%), and pyrexia (2%).
conclusionsIn this study conducted at multiple sites in India, sofosbuvir-velpatasvir administered without genotype restriction or on-treatment safety assessments was well-tolerated and highly effective.
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