Evidence map›Paper›PMID 25733369›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2015

Utility of hepatitis C viral load monitoring on direct-acting antiviral therapy.

Sreetha Sidharthan, Anita Kohli, Zayani Sims, Amy Nelson, Anu Osinusi, Henry Masur, Shyam Kottilil

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 2 pooled it
9.6field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 101 citations in OpenAlex.

  1. Pooled it
  2. SASLT guidelines: Update in treatment of Hepatitis C virus infection.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2016
    Guideline
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Evaluation of GeneXpert and advanced biological laboratories UltraGene HCV diagnostic detection and performance against Roche real time PCR in Myanmar.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2024
    Article
  9. Utility of On-Treatment Viral Loads During Treatment With Direct-Acting Antivirals in Patients Infected With Chronic Viral Hepatitis C.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2022
    Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Early HCV viral kinetics under DAAs may optimize duration of therapy in patients with compensated cirrhosis.Liver international : official journal of the International Association for the Study of the Liver · 2019
    Article
  20. Field evaluation of GeneXpertJournal of viral hepatitis · 2019
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 1 country.

Sreetha SidharthanCritical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda.
Anita KohliCritical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda.
Zayani SimsCritical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda.
Amy NelsonInstitute of Human Virology, University of Maryland, Baltimore Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Anu OsinusiLaboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland Gilead Sciences Inc, Foster City, California.
Henry MasurCritical Care Medicine Department, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda.
Shyam KottililInstitute of Human Virology, University of Maryland, Baltimore Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
National Institutes of Health Clinical Center · USGilead Sciences (United States) · USNational Institutes of Health · USUniversity of Maryland, Baltimore · US

Funding

DC Partnership for HIV/AIDS Progress (DC PFAP)ZIACL009010 · CLC · CLINICAL CENTER · PI MASUR, HENRY · 2010 to 2025
$0k
Analysis of Stored Samples Collected Using Previously Expired ProtocolsZIACL009021 · CLC · CLINICAL CENTER · PI MASUR, HENRY · 2015 to 2024
$0k
CCR NIH HHS HHSN261200800001CNCI NIH HHS HHSN261200800001E
6 · The paper itself

Abstract

backgroundHepatitis C virus (HCV) RNA loads serve as predictors of treatment response during interferon-based therapy. We evaluated the predictive ability of HCV RNA levels at end of treatment (EOT) for sustained virologic response (SVR12) during interferon-sparing direct-acting antiviral therapies.

methodsHCV genotype 1-infected, treatment-naive patients were treated with sofosbuvir and ribavirin for 24 weeks (n = 55), sofosbuvir and ledipasvir for 12 weeks (n = 20), sofosbuvir, ledipasvir, and GS-9669 for 6 weeks (n = 20), or sofosbuvir, ledipasvir, and GS-9451 for 6 weeks (n = 19). Measurements of HCV RNA were performed using the Roche COBAS TaqMan HCV test and the Abbott RealTime HCV assay. Positive predictive value (PPV) and negative predictive value (NPV) of HCV RNA less than the lower limit of quantification (<LLOQ) at EOT for SVR12 were calculated.

resultsAll 55 patients treated with sofosbuvir and ribavirin had HCV RNA <LLOQ at EOT by the Roche and Abbott assays, but only 38 achieved SVR12 (PPV, 69%). Among patients treated with sofosbuvir and ledipasvir with or without GS-9669 or GS-9451, 100% (59/59) had HCV RNA <LLOQ by the Roche assay and 1 relapsed (PPV, 98%). By the Abbott assay, 90% (53/59) had HCV RNA <LLOQ, of whom 1 patient relapsed (PPV, 98%). Notably, 6 patients with HCV RNA ≥LLOQ at EOT (range, 14-64 IU/mL) achieved SVR12 (NPV, 0%). Quantifiable HCV RNA (range, 15-57 IU/mL) was measured 2 weeks posttreatment in 4 individuals, and 4 weeks posttreatment in 1 patient (14 IU/mL).

conclusionsContrary to past experience with interferon-containing treatments, low levels of quantifiable HCV RNA at EOT do not preclude treatment success.

Indexed as

AdultAgedAntiviral AgentsDrug MonitoringFemaleHepacivirusHepatitis CHumansMaleMiddle AgedPredictive Value of TestsRNA, ViralViral LoadAntiviral AgentsRNA, Viraldirect-acting antiviralHCV RNAhepatitis Cviral load

Identifiers

PMID25733369
PMCPMC4834854
OpenAlexW2116998649

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.