Jürgen K. Rockstroh, Vicente Soriano, Frank Plonski, Meena Bansal, Gerd Fätkenheuer, Catherine B. Small, David M. Asmuth, Gilles Pialoux, Geoffrey Mukwaya, Shyla Jagannatha, Jayvant Heera, Juan A. Pineda (2015), Hepatic Safety in Subjects With HIV-1 and Hepatitis C and/or B Virus: A Randomised, Double-Blind Study of Maraviroc vs Placebo in Combination With Antiretroviral Agents, 16(4) http://dx.doi.org/10.1179/1528433615Z.0000000029
In a previous issue of this journal [HIV Clinical Trials 2015; 16(2):72–80)], Rockstroh and colleagues (2015) reported the 48-week results for a maraviroc hepatic safety study in subjects with HIV-1 and Hepatitis C and/or B virus. Subsequent to publication, it was noted that programming errors resulted in incorrect data results being provided within the manuscript. The programming errors were confirmed to be limited in scope to the following results provided in the manuscript: 1. Number of subjects on maraviroc maintaining viral suppression, and 2. Figure 3 (change from baseline for total, indirect, and direct bilirubin).
Due to an error in programming, viral load data were inadvertently included for two subjects who continued to be followed in the study but who had discontinued treatment. These two subjects on the maraviroc arm were previously reported to have maintained HIV-1 viral suppression (<48copies/ml) through 48 weeks of treatment. The corrected results should reflect 77.2% (n = 54) subjects on maraviroc who maintained viral suppression, down from the previously published results of 80.0% (n = 56). There is no change to the published results for the subjects who were randomized to placebo.
Separate programming errors resulted in the use of on-treatment bilirubin laboratory data when a baseline laboratory result was not available. This coupled with the lack of consistent use of standardized lab units resulted in the summary of change from baseline graphs found in Figure 3 for total, indirect, and direct bilirubin to be inaccurate. Analysis of the data with the corrected programming did not alter the conclusions or findings from the published manuscript, as the change from baseline results between the two arms continued to fail to reach statistical significance. However, the updated Figure 3 is being provided for your reference (attached). Please note there were no changes to the AST or ALT summary of changes from baseline graphs found in Figure 3.
All other results remain accurate and no other updates are required. This letter is being provided to alert you as to the errors present in the manuscript for the evaluation and appropriate action. Please do not hesitate to contact our corresponding author should you have any questions or concerns.