Evidence map›Paper›PMID 20101190›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2010

HIV/Hepatitis C virus-coinfected virologic responders to pegylated interferon and ribavirin therapy more frequently incur interferon-related adverse events than nonresponders do.

Anu Osinusi, Joseph J Rasimas, Rachel Bishop, Michael Proschan, Mary McLaughlin, Alison Murphy, Karoll J Cortez, Michael A Polis, Henry Masur, Donald Rosenstein and 1 more

Registry-linked trialOpen access · greenAbstract readClinical Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03117816 (Efficacy and Safety of Pegylated Proline Interferon Alpha 2b), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.1field-weighted citation impact, top 23% of its field
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.

NCT03117816 phase3completednot on this mapstarted 2017, after this paper: background citation

Efficacy and Safety of Pegylated Proline Interferon Alpha 2b (AOP2014) in Maintaining Deep Molecular Remissions in Patients With Chronic Myeloid Leukemia (CML) Who Discontinue ABL-Kinase Inhibitor Therapy - a Randomized Phase III, Multicenter Trial With Post-study Follow-up

TypeinterventionalSponsorPhilipps University MarburgRan2017 to 2022Enrolled214ConditionsChronic Myeloid Leukemia in RemissionArmsAOP2014 / Pegylated-Proline-interferon alpha-2b, Surveillance
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Review
  3. Host-Directed Antiviral Therapy.Clinical microbiology reviews · 2020
    Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
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

11 authors at 5 institutions in 1 country.

Anu OsinusiLaboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA.
Joseph J Rasimas
Rachel Bishop
Michael Proschan
Mary McLaughlin
Alison Murphy
Karoll J Cortez
Michael A Polis
Henry Masur
Donald Rosenstein
Shyam Kottilil
National Institute of Allergy and Infectious Diseases · USNational Institutes of Health · USNational Institute of Mental Health · USNational Institutes of Health Clinical Center · USNational Eye Institute · US

Funding

Therapeutic Strategies for the Management of HCV/HIV co- infectionZIAAI000390 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI FAUCI, ANTHONY S. · 2009 to 2014
$4.2M
Therapeutic Strategies for the Management of HCV/HIV co- infectionZ01AI000390 · NIAID · NIAID EXTRAMURAL ACTIVITIES · PI FAUCI, ANTHONY S. · 1985 to 2008
$348k
Intramural NIH HHS Z01 AI000390Intramural NIH HHS ZIA AI000390
6 · The paper itself

Abstract

backgroundThis study aimed to assess the relationship between interferon (IFN)-related adverse effects and Hepatitis C virus (HCV) virologic response in HIV/HCV-coinfected individuals treated with pegylated interferon and ribavirin.

methodsWe conducted 2 prospective, open-label trials treating HIV/HCV-coinfected individuals with pegylated interferon alpha-2b or alpha-2a and ribavirin for 48 weeks. Safety laboratories, HCV RNA, psychiatric, and ophthalmologic evaluations were performed at baseline and monthly until week 72.

resultsResponders were defined as those with HCV RNA decline of > or = 2-log drop from baseline and nonresponders were those who did not. Remarkably, of the 27 patients (50%) who developed psychiatric toxicities, 26 patients were responders, although only 1 of 14 virologic nonresponders experienced psychiatric toxicity. Other adverse effects, such as anemia and ophthalmologic toxicities, were also more frequent in responders compared with nonresponders. Decline in CD4 T-cell counts strongly correlated with HCV viral decline.

conclusionsOur study demonstrates coupling of antiviral effect and occurrence of adverse events in HIV/HCV-coinfected patients. These patients with IFN-related adverse effects need a multidisciplinary treatment approach, hence, they are more likely to achieve sustained virologic response. Future studies are needed to evaluate the factors that predict the development of IFN-alpha-dependent adverse events before therapy.

Indexed as

AdultAnemiaAntiviral AgentsDrug-Related Side Effects and Adverse ReactionsEye DiseasesFemaleHepacivirusHepatitis CHIV InfectionsHumansInterferon-alphaInterferon alpha-2MaleMental DisordersMiddle AgedPolyethylene GlycolsAntiviral AgentsInterferon-alphaInterferon alpha-2peginterferon alfa-2apeginterferon alfa-2bPolyethylene GlycolsRecombinant ProteinsRibavirinRNA, Viral

Identifiers

PMID20101190
PMCPMC2852116
OpenAlexW2064518456

What OpenQuestion holds

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Registered trials

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.