Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection
2014 · paper · Clinical trials
A phase 3 open-label trial of once-daily ledipasvir–sofosbuvir, with or without ribavirin, for 12 or 24 weeks in 865 previously untreated people with hepatitis C genotype 1. Sustained virologic response rates were 97–99% across all four groups.
1 finding
Reference or label Ref 11 reads "Gastroenterology 2013; 146:736-43." while ref 17 places the same volume in 2014 ("Gastroenterology 2014;146:442-52.").
- p. 10 References, entry 11 (Gane et al.)
type 1 infection. Gastroenterology 2013; 146:736-43.
- p. 10 References, entry 17 (Afdhal et al.)
enterology 2014;146:442-52.
- p. 10 Reference 11
Gastroenterology 2013; 146:736-43.
- p. 10 Reference 17
Gastro-enterology 2014;146:442-52.
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: that Gastroenterology vol 146 is the 2014 volume and that Gane et al. appeared in 2014. Within the files, page 10 shows volume 146 dated 2013 in ref 11 and 2014 in ref 17, which is internally inconsistent; ref 11's year is likely wrong.
Second check: another model agreed
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3 minor (typos and the like; most checked by the judge only)
Wording Introduction says current regimens include "weekly injections of recombinant human interferon alfa", but the weekly agent is peginterferon, which the same section later calls "with or without peginterferon.1"
- p. 2 Introduction, para 1
weekly injections of recombinant human inter-feron alfa and ribavirin
- p. 2 Introduction, para 3
with or without peginterferon.1
Judge's note: Page 2 image checked. Peginterferon is a pegylated recombinant interferon alfa, so the first wording is loose rather than false. Still, 'weekly' fits only the pegylated form, and later in the same section the drug is called peginterferon. This is a minor naming inconsistency.
Second check: another model agreed
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Wording Discussion says nonadherence "was documented by means of serum assays for drug levels", while Results report "plasma concentrations of ledipasvir and GS-331007".
- p. 9 Discussion, para on virologic failure
which was documented by means of se-rum assays for drug levels
- p. 4 Results, Efficacy
had plasma concentrations of ledipas-vir and GS-331007
Judge's note: Pages 4 and 9 checked. The same measurement is described with two different specimen types. This is probably loose usage, a minor wording inconsistency.
Second check: another model agreed
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Wording "93% had only events that were mild to moderate in severity (Table 3)": Table 3 has no adverse-event severity data, so the 93% cannot be checked against the table cited.
- p. 6 Results, Safety, 3rd paragraph
93% had only events that were mild to moderate in severity (Table 3)
- p. 8 Table 3
Treatment Discontinuations, Adverse Events, and Hematologic Abnormalities.
Judge's note: Table 3 (p8) checked. Its rows are duration, discontinuations, serious AEs, any AE, common AEs and hematologic abnormalities, with no severity grades. The pointer probably supports the paragraph's 79 to 92% figure, but placed directly after the 93% claim it points to a table that does not contain that figure.
Second check: another model agreed