Trial reportPloS one2019
Randomized feasibility trial of directly observed versus unobserved hepatitis C treatment with ledipasvir-sofosbuvir among people who inject drugs.
Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02609893 (Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs), which is not on this map. Cited by 14 papers, 4 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.
Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs
Who cites it
14 citing papers in PubMed, 4 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Prevention of Viral Hepatitis and HIV Infection among People Who Inject Drugs: A Systematic Review and Meta-Analysis.Viruses · 2024Pooled it
- Interventions to increase linkage to care and adherence to treatment for hepatitis C among people who inject drugs: A systematic review and practical considerations from an expert panel consultation.The International journal on drug policy · 2022Pooled it
- Efficacy and safety of ledipasvir/sofosbuvir for hepatitis C among drug users: a systematic review and meta-analysis.Virology journal · 2021Pooled it
- Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases-Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection.Hepatology (Baltimore, Md.) · 2020Guideline
- Randomized clinical trial: Direct-acting antivirals as treatment for hepatitis C in people who inject drugs: Delivered in needle and syringe programs via directly observed therapy versus fortnightly collection.Journal of viral hepatitis · 2022Trial
- Evaluation of Hepatitis C Treatment Outcomes Among Patients Enrolled in Outpatient Parenteral Antibiotic Therapy-Boston, Massachusetts, 2016-2021.Open forum infectious diseases · 2023Article
- Closing the hepatitis C treatment gap: United States strategies to improve retention in care.Journal of viral hepatitis · 2022Review
- HCV spread among female incarcerated population and treatment pathways to viral elimination in Italian prison settings: clinical perspectives and medico legal aspects.BMC infectious diseases · 2022Article
- Review
- Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update.Health technology assessment (Winchester, England) · 2021Article
- Patient Centeredness in Hepatitis C Direct-Acting Antiviral Treatment Delivery to People Who Inject Drugs: A Scoping Review.The patient · 2021Article
- Adherence to Direct-Acting Antiviral Therapy in People Actively Using Drugs and Alcohol: The INCLUD Study.Open forum infectious diseases · 2021Article
- High hepatitis C virus seropositivity, viremia, and associated risk factors among trans women living in San Francisco, California.PloS one · 2021Article
- The use of technology-based adherence monitoring in the treatment of hepatitis C virus.Therapeutic advances in infectious diseaseReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 2 institutions in 1 country.
Funding
Abstract
aimsThe advent of direct-acting antivirals for hepatitis C virus (HCV) and limited effectiveness of prevention have generated interest in "Treatment as Prevention" (TasP), in which those most likely to transmit HCV (i.e. people who inject drugs [PWID]) are treated to reduced secondary transmission. However, there are scant data regarding the feasibility of treating PWID at high risk for secondary transmission or the optimal approach to treatment delivery.
methodsWe conducted a 2:1 randomized trial of modified directly-observed (mDOT) versus unobserved HCV treatment with ledipasvir-sofosbuvir daily for 8 weeks among PWID with 36 weeks of follow-up in San Francisco from 2015-2017. We evaluated recruitment-enrollment, treatment completion, end-of-treatment and 12-week response, and reinfection rate.
resultsOf 83 individuals eligible for screening, 72 (87.6%) attended the screening visit, 33 were eligible, and 31 enrolled; mean age was 42 years, 81% were male, 74% white. All but one participant (in the mDOT arm) completed treatment and 89.4% of mDOT and 96.6% of unobserved arm visits were attended. HCV was undetectable for 96.8% (30/31) at end of treatment and 89.7% (26/29) 12 weeks later (1 relapse, 1 reinfection), with no differences by arm. Two additional reinfections were subsequently identified, for a reinfection rate of 16.3 (95% CI 5.3-50.5) per 100 person-years of observation.
conclusionsIt was feasible to recruit active PWID for HCV treatment and achieve high retention, viral response, and satisfaction with either mDOT or unobserved protocols, supporting treatment of PWID at risk of transmitting HCV to others. The reinfection rate suggests we successfully reached a high-risk population and that successful HCV TasP initiatives may aim to be sufficient in scope to significantly lower prevalence in the community.
trial registrationclinicaltrials.gov NCT02609893.
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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.