Evidence map›Paper›PMID 30946776›Full record

Observational studyPloS one2019

Real-world effectiveness and safety of sofosbuvir/velpatasvir and ledipasvir/sofosbuvir hepatitis C treatment in a single centre in Germany.

Peter Buggisch, Karsten Wursthorn, Albrecht Stoehr, Petar K Atanasov, Romain Supiot, Janet Lee, Jie Ting, Joerg Petersen

Abstract readObservational Study
In one paragraph

Observational study in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

  1. Article
  2. Article
  3. Impact of Hepatitis C Virus Infection and Treatment on Mortality in the Country of Georgia, 2015-2020.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
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  4. Article
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  7. Review
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  12. Three Years of Progress Toward Achieving Hepatitis C Elimination in the Country of Georgia, April 2015-March 2018.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
    Article
  13. Global real-world evidence of sofosbuvir/velpatasvir as simple, effective HCV treatment: Analysis of 5552 patients from 12 cohorts.Liver international : official journal of the International Association for the Study of the Liver · 2020
    Article
  14. Article
  15. Article
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Peter BuggischAsklepios Klinik St. Georg Haus L, IFI Institut für Interdisziplinäre Medizin, Hamburg, Germany.
Karsten WursthornAsklepios Klinik St. Georg Haus L, IFI Institut für Interdisziplinäre Medizin, Hamburg, Germany.
Albrecht StoehrAsklepios Klinik St. Georg Haus L, IFI Institut für Interdisziplinäre Medizin, Hamburg, Germany.
Petar K AtanasovAmaris Consulting, London, United Kingdom.
Romain SupiotAmaris Consulting, London, United Kingdom.ORCID 0000-0001-5439-5296
Janet LeeGilead Sciences, Inc., Foster City, CA, United States of America.
Jie TingGilead Sciences, Inc., Foster City, CA, United States of America.
Joerg PetersenAsklepios Klinik St. Georg Haus L, IFI Institut für Interdisziplinäre Medizin, Hamburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNewer direct-acting antiviral therapies are increasingly becoming the therapy of choice in patients with hepatitis C virus (HCV) infection. Here, we report the safety and effectiveness of sofosbuvir/velpatasvir (SOF/VEL) and ledipasvir/sofosbuvir (LDV/SOF) in real-world cohorts in Germany.

methodsPatients initiated on SOF/VEL 12 weeks or LDV/SOF 8, 12 or 24 weeks regimens in a single German centre were included in this study. Data on treatment outcomes and adverse events (AE) were analysed in patients with available sustained virologic response 12 weeks after cessation of treatment (SVR12) information overall and by subgroups.

resultsThis study included 115 patients who received SOF/VEL from July-2016 to July-2017, and 249 patients who received LDV/SOF from November-2014 to September-2015. Overall, SVR12 was achieved in 99% of patients on SOF/VEL ± ribavirin 12 weeks independent of HCV genotype, treatment history, or cirrhosis status, and in 96% of patients treated with LDV/SOF 8 weeks or LDV/SOF ± ribavirin 12 or 24 weeks. In genotype 1 treatment-naïve, non-cirrhotic patients, ≥99% achieved SVR12 across SOF/VEL and LDV/SOF regimens. Likewise, 100% of genotype 3-cirrhotic patients on SOF/VEL ± ribavirin regimens achieved SVR12. Grade 3/4 AE were reported in 13 (5.2%) patients on LDV/SOF and in 1 (<1%) patient on SOF/VEL.

conclusionOverall, SOF/VEL and LDV/SOF achieved high SVR rates in a broad patient population. We showed the effectiveness of SOF/VEL as a pan-genotypic regimen, and regardless of treatment history or cirrhosis status. Use of such therapies improves outcomes and contributes towards the global efforts to eradicate HCV.

Indexed as

AdultAgedAntiviral AgentsBenzimidazolesCarbamatesCohort StudiesDrug Administration ScheduleDrug CombinationsFemaleFluorenesGenotypeGermanyHepacivirusHepatitis C, ChronicHeterocyclic Compounds, 4 or More RingsHumansAntiviral AgentsBenzimidazolesCarbamatesDrug CombinationsFluorenesHeterocyclic Compounds, 4 or More Ringsledipasvir, sofosbuvir drug combinationRibavirinSofosbuvirsofosbuvir-velpatasvir drug combinationUridine Monophosphate

Identifiers

PMID30946776
PMCPMC6448908

What OpenQuestion holds

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Registered trials

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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.