dc.contributor.author
Andersohn, Frank
dc.contributor.author
Claes, Anne-Kathrin
dc.contributor.author
Kulp, Werner
dc.contributor.author
Mahlich, Jörg
dc.contributor.author
Rockstroh, Jürgen Kurt
dc.date.accessioned
2018-06-08T04:12:38Z
dc.date.available
2016-02-29T09:52:03.788Z
dc.identifier.uri
https://refubium.fu-berlin.de/handle/fub188/16803
dc.identifier.uri
http://dx.doi.org/10.17169/refubium-20984
dc.description.abstract
Background About one third of patients infected with human immunodeficiency
virus (HIV) also have chronic hepatitis due to hepatitis C virus (HCV). HCV
therapy with simeprevir, pegylated interferon alfa (PegIFNα) and ribavirin
(RBV) have been shown to be superior to PegIFNα + RBV alone in non-HIV
patients, but no randomized trials in patients with HCV genotype 1 (HCV-1) /
HIV coinfection are available. Methods This was a historical comparison of
study C212 (simeprevir + PegIFNα-2a + RBV in patients with HCV-1/HIV
coinfection) with studies in which HCV-1/HIV coinfected patients were treated
with PegIFNα-2a + RBV alone. A systematic literature search was performed to
identify eligible studies. Efficacy and safety results of PegIFNα-2a + RBV
studies were combined in random- and fixed-effects inverse-variance weighted
meta-analyses of proportions using the Freeman-Tukey double arcsin
transformation method, and compared with the results of study C212. Results
The literature search revealed a total of 2392 records, with 206 articles
selected for full-text review. Finally, 11 relevant articles reporting on 12
relevant study groups were included. Results on sustained virologic response
24 weeks after end of treatment (SVR24) were available from all 12 study
groups. Pooled SVR24 for PegIFNα-2a + RBV from the random-effects meta-
analysis was 28.2 % (95 % CI 23.8 % to 32.9 %). The comparison between study
C212 (SVR24 = 72.6 %; 95 % CI 63.1 % to 80.9 %) revealed substantial
superiority of simeprevir + PegIFNα-2a + RBV compared to PegIFNα-2a + RBV
alone, with an absolute risk difference of 45 % (95 % CI 34 to 55). This
finding was robust in a sensitivity analysis that only included historical
studies with a planned treatment duration of at least 48 weeks and the same
RBV dose as in study C212. No increases in the frequency of important adverse
event categories including anemia were identified, but these analyses were
limited by the low number of studies. Conclusion This historical comparison
provides first systematic evidence for the superiority of simeprevir +
PegIFNα-2a + RBV compared to PegIFNα-2a + RBV in patients with HCV-1 / HIV
coinfection. Given the limitations of the historical comparison for safety
endpoints, additional data on the comparative safety of simeprevir in patients
with HCV-1 / HIV coinfection would be desirable. Trial registration Identifier
for study TMC435-TiDP16-C212 (ClinicalTrials.gov): NCT01479868.
en
dc.rights.uri
http://creativecommons.org/licenses/by/4.0/
dc.subject
Chronic hepatitis
dc.subject
Hepatitis C virus
dc.subject
Human immunodeficiency virus
dc.subject
Pegylated interferon alfa
dc.subject
Historical comparison
dc.subject.ddc
600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit
dc.title
Simeprevir with pegylated interferon alfa 2a plus ribavirin for treatment of
hepatitis C virus genotype 1 in patients with HIV
dc.type
Wissenschaftlicher Artikel
dcterms.bibliographicCitation
BMC Infectious Diseases. - 16 (2016), Artikel Nr. 10
dc.title.subtitle
a meta-analysis and historical comparison
dcterms.bibliographicCitation.doi
10.1186/s12879-015-1311-3
dcterms.bibliographicCitation.url
http://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-015-1311-3
refubium.affiliation
Charité - Universitätsmedizin Berlin
de
refubium.mycore.fudocsId
FUDOCS_document_000000024033
refubium.note.author
Der Artikel wurde in einer reinen Open-Access-Zeitschrift publiziert.
refubium.resourceType.isindependentpub
no
refubium.mycore.derivateId
FUDOCS_derivate_000000006036
dcterms.accessRights.openaire
open access