Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection
2015 · paper · Clinical trials
A phase 3 placebo-controlled study of 12 weeks of once-daily sofosbuvir–velpatasvir in patients with hepatitis C genotypes 1, 2, 4, 5 or 6, including those with compensated cirrhosis. Sustained virologic response was 99%; no placebo patients responded.
0 findings
None that passed a second check.
9 minor (typos and the like; most checked by the judge only)
Reference or label Methods: "HCV genotype 2 (ASTRAL-2) and HCV genotype 3 (ASTRAL-3), and the results are reported now in the Journal.14,15". Ref 15 is "Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis", which is neither of these trials.
- p. 2 Methods, Patients, second paragraph
HCV genotype 2 (ASTRAL-2) and HCV geno-type 3 (ASTRAL-3), and the results are reported now in the Journal.14,15
- p. 9 Reference 15
Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis.
- p. 2 Methods, Patients
type 3 (ASTRAL-3), and the results are reported now in the Journal.14,15
- p. 2 Methods, Patients, para 2
(ASTRAL-3), and the results are reported now in the Journal.14,15
Judge's note: Reference list on p9: ref 14 (Foster et al., genotype 2 and 3 infection) covers both trials named in the sentence. Ref 15 (Curry et al.) is the decompensated-cirrhosis trial. In the Discussion, the citation 14,15 on 'genotype 3 and those with decompensated cirrhosis' is correct, but in the Methods sentence ref 15 does not support the claim. It may have been meant as a general pointer to the companion papers, so this is minor.
Second check: another model agreed
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Wording Introduction says HCV "infects up to 150 million people worldwide" (refs 1,2), but the Discussion says "Of the 170 million patients who are chronically infected with HCV worldwide" (ref 17).
- p. 2 Introduction, first paragraph
up to 150 million people worldwide
- p. 7 Discussion, first paragraph
Of the 170 million patients who are chronically infected with HCV worldwide
- p. 2 Introduction, paragraph 1
infects up to 150 million people worldwide
- p. 7 Discussion, paragraph 1
Of the 170 million patients who are chronically
Only the authors can say what is right here.
Judge's note: Checked both crops (p2 Introduction, p7 Discussion). The figures cite different sources, but 'up to 150 million' is worded as a ceiling and 170 million chronically infected is above it. The paper does not reconcile the two estimates. This is a wording inconsistency between estimates from different sources, so it goes to the authors as a query.
Second check: another model agreed
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Wording Results text lists the four other non-SVR patients as 2 lost to follow-up, "one discontinued treatment because of an adverse event, and one died". Table 2 lists them as Loss to follow-up 2, "Withdrawal of consent" 1, Death 1.
- p. 4 Results, Efficacy, last paragraph
one discontinued treatment because of an adverse event, and one died during follow-up
- p. 6 Table 2, Other reason for classification as failure
Withdrawal of consent
Only the authors can say what is right here.
Judge's note: Checked p4 text and the p6 Table 2 crop. The table has no adverse-event category, and the text never says that the patient who stopped after an anxiety attack (Safety section) withdrew consent. The patient may have formally withdrawn consent after the adverse event, so the authors should clarify the classification.
Second check: another model agreed
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Wording Methods: "No formal comparison of safety between the groups was planned." Results: "There was no significant difference in the rates of any adverse event ..." and "did not differ significantly", with no test named.
- p. 4 Statistical Analysis, second paragraph
No formal comparison of safety between the groups was planned.
- p. 6 Results, Safety, last paragraph
There was no significant difference in the rates of any adverse event
Judge's note: Checked both crops. The Results use significance language although the Methods say no formal safety comparison was planned, and no test is identified. This could be a post hoc test, so it is an unexplained wording point rather than a contradiction of the data.
Second check: another model agreed
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Typo Genotype 1b SVR given as "99% (95% CI, 95 to 100)" for 117/118. Other groups with one failure (120/121 cirrhosis, 34/35 genotype 5) have their upper bound printed as ">99".
- p. 4 Results, Efficacy, second paragraph
99% (95% CI, 95 to 100) with genotype 1b
- p. 4 Results, Efficacy, cirrhosis
120 (99% [95% CI, 95 to >99])
Judge's note: Table 2 shows 117/118 for 1b. The exact Clopper-Pearson upper bound for n-1/n with n=118 is 0.975^(1/118), about 99.98%. That rounds to 100, so the value is not wrong, but the paper writes '>99' for the analogous one-failure groups and keeps '100' otherwise for groups with no failures. Only the reporting convention differs.
Second check: none (judge only)
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Typo Table 1 footnote ¶: "a FibroTest score of more 0.75" is missing 'than'. The Methods read "more than 0.75".
- p. 5 Table 1, footnote ¶
a FibroTest score of more 0.75
Judge's note: The page-5 crop confirms that the word 'than' is absent. The same footnote also reads 'an Ishak score 5 or more', where the Methods have 'of 5'.
Second check: none (judge only)
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Typo Reference 9 title reads "with potent antiviral activity, board genotypic coverage"; 'board' should be 'broad'.
- p. 9 Reference 9
board geno-typic coverage
- p. 9 Reference 9
board geno-
Judge's note: The reference list on p9 shows 'board geno-typic coverage'. It is evidently a misspelling of 'broad', which fits the paper's description of velpatasvir as pangenotypic.
Second check: none (judge only)
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Typo Reference 6 URL printed as "(http//www.hcvguidelines.org)"; the colon after 'http' is missing.
- p. 9 Reference 6
(http//www.hcvguidelines.org)
Judge's note: The p9 page image shows 'http//www'. The text layer also reads 'http//www' with no colon, so this is not an extraction artefact.
Second check: none (judge only)
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Typo Reference 16 first author printed as "Weins BL"; the author is likely Wiens BL.
- p. 9 Reference 16
Weins BL, Lystig TC, Berry SM.
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the first author of 'Recent statistical contributions to medical device development' (Ther Innov Reg Sci 2014;48:90-7) is Brian L. Wiens. The p9 crop confirms the page reads 'Weins BL, Lystig TC, Berry SM.'
Second check: none (judge only)