Evidence map›Paper›PMID 31516269›Full record

ReviewJournal of clinical and experimental hepatology

New Direct-Acting Antivirals for the Treatment of Patients With Hepatitis C Virus Infection: A Systematic Review of Randomized Controlled Trials.

Valentina Pecoraro, Rita Banzi, Elisabetta Cariani, Johanna Chester, Erica Villa, Roberto D'Amico, Vittorio Bertele', Tommaso Trenti

Open access · greenAbstract readReview
In one paragraph

Review in Journal of clinical and experimental hepatology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
3.0field-weighted citation impact, top 7% 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

26 citing papers in PubMed, 53 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Observational
  5. Novel Pyrazino[1,2-Viruses · 2024
    Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Chronic HCV infection promotes cytotoxicity in antigen-specific CD8Frontiers in virology (Lausanne, Switzerland) · 2023
    Article
  13. Article
  14. Article
  15. In a Real-Life Setting, Direct-Acting Antivirals to People Who Inject Drugs with Chronic Hepatitis C in Turkey.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2022
    Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Article
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

8 authors at 3 institutions in 1 country.

Valentina PecoraroUnit of Laboratory Medicine, Ospedale Civile Sant'Agostino Estense, Modena, Italy.
Rita BanziCenter for Drug Regulatory Policies, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
Elisabetta CarianiUnit of Laboratory Medicine, Ospedale Civile Sant'Agostino Estense, Modena, Italy.
Johanna ChesterDepartment of Surgery, Medical, Dentistry and Morphological Sciences, University of Modena e Reggio Emilia, Italy.
Erica VillaDepartment of Gastroenterology - AOU Modena, Modena, Italy.
Roberto D'AmicoCochrane Italy - University of Modena and Reggio Emilia, Italy.
Vittorio Bertele'Center for Drug Regulatory Policies, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
Tommaso TrentiUnit of Laboratory Medicine, Ospedale Civile Sant'Agostino Estense, Modena, Italy.
Mario Negri Institute for Pharmacological Research · ITUniversity of Modena and Reggio Emilia · ITAzienda Unita' Sanitaria Locale Di Modena · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNew direct-acting antiviral agents (DAAs) approved for the treatment of patients infected by Hepatitis C virus (HCV) are well tolerated and increase sustained virological response (SVR) rate. We summarize current evidence on the efficacy and safety from comparative randomized controlled trials (RCTs) of DAAs.

methodsWe systematically searched MEDLINE, Embase, Scopus, CENTRAL, and Lilacs as well as a list of reference literature. We included RCTs comparing DAAs with placebo or active control and reporting response rates and adverse events according to antiviral regimens. Risk ratios (RRs) were pooled as appropriate. We assessed the risk of bias of included studies and graded the quality of evidence according to the GRADE method.

resultsWe included 28 RCTs, enrolling more than 7000 patients. The quality of evidence was generally low. Twelve-week treatment with DAAs in naïve patients significantly increased SVR12 and SVR24 compared with placebo (RR 1.4, 95% CI 1.3-1.6; RR 1.5, 95% CI 1.4-1.6, respectively). This means that for every 1000 patients, 240 or 260 more patients experienced SVR12 or SVR24 if treated with any DAAs. We could not find RCTs assessing progression of liver disease or development of hepatocellular carcinoma. DAAs were not associated with higher incidence of serious adverse events or discontinuation due to adverse events.

conclusionsThis systematic review confirms that new DAAs are more effective in inducing SVR than placebo. Outside clinical trials, in real word, HCV cure with DAA regimens occurs in less than 90% of patients, so further comparative evaluations are needed to establish their long-term effects.

Indexed as

AE, adverse eventCI, confidence intervalDAA, direct-acting antiviral agentHCC, hepatocellular carcinomaHCV, Hepatitis C virushepatitis Clivermeta-analysisNNPIs, nonnucleoside polymerase inhibitorsNPIs, nucleoside polymerase inhibitorsoutcome researchPEG-IFN, pegylated interferonPrIs, protease inhibitorsRAVs, resistance-associated variantsRBV, RibavirinRCT, randomized controlled trialRR, risk ratioSAEs, serious adverse eventsSE, standard errorSVR, sustained virological responsesystematic review

Identifiers

PMID31516269
PMCPMC6728536
OpenAlexW2883674917

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.