Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2017
Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02480712 (A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus), which is not on this map. Cited by 73 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
Who cites it
73 citing papers in PubMed, 2 syntheses or guidelines pooled it, 156 citations in OpenAlex.
- 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
- 2017 KASL clinical practice guidelines management of hepatitis C: Treatment of chronic hepatitis C.Clinical and molecular hepatology · 2018Guideline
- 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
- Nurse case management to improve the hepatitis C care continuum in HIV co-infection: Results of a randomized controlled trial.Journal of viral hepatitis · 2020Trial
- Glecaprevir/Pibrentasvir in patients with chronic HCV genotype 3 infection: An integrated phase 2/3 analysis.Journal of viral hepatitis · 2019Trial
- Care2Cure: A randomized controlled trial protocol for evaluating nurse case management to improve the hepatitis C care continuum within HIV primary care.Research in nursing & health · 2018Trial
- Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Coinfected With Hepatitis C Virus and Human Immunodeficiency Virus Type 1: The EXPEDITION-2 Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Trial
- Article
- 2025 KASL clinical practice guidelines for management of hepatitis C.Clinical and molecular hepatology · 2026Article
- [Recent Advances in the Treatment of Chronic Hepatitis C].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2025Review
- Hepatic Markers and Immunological Trajectories in a Cohort of Patients with HIV and Hepatitis C Virus Coinfection Treated with Direct-Acting Antivirals.AIDS research and human retroviruses · 2025Article
- Hepatitis C-Everything a Primary Care Physician Needs to Know About Diagnosis, Management, and Follow-Up.Journal of clinical medicine · 2025Review
- Drug interactions in people with HIV treated with antivirals for other viral illnesses.Expert opinion on drug metabolism & toxicology · 2025Review
- Impact of Policy Changes Expanding Access to Direct-Acting Antivirals on Hepatitis C Virus-Related Hospitalizations in People With HIV: A Population-Based Study.Open forum infectious diseases · 2025Article
- Article
- Cost-effectiveness analysis of emergency department-based hepatitis C screening and linkage-to-care program.BMC health services research · 2024Article
- Treatment Outcomes of HCV Infection in People Living with HIV: A Case Series from a Single Center in Korea.Infection & chemotherapy · 2024Article
- Hepatitis C virus eradication in people living with human immunodeficiency virus: Where are we now?World journal of hepatology · 2024Article
- A simple, feasible, efficient and safe treatment strategy of sofosbuvir/velpatasvir for chronic HCV/HIV-1 coinfected patients regardless of HCV genotypes: a multicenter, open-label study in China.The Lancet regional health. Western Pacific · 2023Article
13 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 12 institutions in 1 country.
Funding
Abstract
backgroundA safe, simple, effective, and pan-genotypic regimen to treat hepatitis C virus (HCV) infection in patients coinfected with human immunodeficiency virus type 1 (HIV-1) remains a medical need. We assessed the efficacy and safety of the NS5B polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir for HCV in patients coinfected with HIV-1.
methodsThis phase 3, open-label, single-arm study at 17 sites in the United States enrolled patients with HCV of any genotype and HIV-1 coinfection, including those with compensated cirrhosis. All patients received sofosbuvir-velpatasvir once daily for 12 weeks. The primary endpoint was sustained virologic response 12 weeks after treatment (SVR12). Efficacy and safety were assessed in all patients receiving at least 1 dose of treatment.
resultsOf 106 patients, 91 (86%) were men, 48 (45%) were black, and 19 (18%) had cirrhosis. SVR12 was achieved by 101 of 106 (95% [95% confidence interval {CI}, 89%-99%]) patients: 74 of 78 (95% [95% CI, 87%-99%]) with genotype 1; all 11 (100% [95% CI, 72%-100%]) with genotype 2; 11 of 12 (92% [95% CI, 62%-100%]) with genotype 3; and all 5 (100% [95% CI, 48%-100%]) with genotype 4. All 19 patients with cirrhosis had SVR12. Two patients relapsed, 2 were lost to follow-up, and 1 withdrew consent. Two discontinued treatment due to adverse events and 2 had serious adverse events. The most common adverse events were fatigue (25%), headache (13%), upper respiratory tract infection (8%), and arthralgia (8%).
conclusionsSofosbuvir-velpatasvir for 12 weeks was safe and provided high rates of SVR12 in patients coinfected with HCV and HIV-1. CLINICAL TRIALS REGISTRATION: NCT02480712.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.