Evidence map›Paper›PMID 36811718›Full record

ArticleDigestive diseases and sciences2023

Ledipasvir/Sofosbuvir Is Effective as Sole Treatment of Porphyria Cutanea Tarda with Chronic Hepatitis C.

Herbert L Bonkovsky, Sean P Rudnick, Christopher D Ma, Jessica R Overbey, Kelly Wang, Denise Faust, Csilla Hallberg, Karli Hedstrom, Hetanshi Naik, Akshata Moghe and 1 more

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Digestive diseases and sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03118674 (Newer Direct-Acting Anti-Viral Agents as Sole Therapy of Porphyria Cutanea Tarda in Subjects With Chronic Hepatitis C), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 26% 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.

NCT03118674 phase2completednot on this map

Newer Direct-Acting Anti-Viral Agents as Sole Therapy of Porphyria Cutanea Tarda in Subjects With Chronic Hepatitis C

TypeinterventionalSponsorWake Forest University Health SciencesRan2017 to 2022Enrolled23ConditionsPorphyria Cutanea Tarda, Hepatitis CArmsHarvoni
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Review
  3. Porphyria cutanea tarda: a unique iron-related disorder.Hematology. American Society of Hematology. Education Program · 2024
    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 3 institutions in 1 country.

Herbert L BonkovskySection On Gastroenterology & Hepatology, Department of Internal Medicine, Wake Forest University School of Medicine, E-112, NRC, 1 Medical Center Blvd, Winston-Salem, NC, 27157, USA. hbonkovs@wakehealth.edu.ORCID http://orcid.org/0000-0001-7387-3230
Sean P RudnickSection On Gastroenterology & Hepatology, Department of Internal Medicine, Wake Forest University School of Medicine, E-112, NRC, 1 Medical Center Blvd, Winston-Salem, NC, 27157, USA.
Christopher D MaSection On Gastroenterology & Hepatology, Department of Internal Medicine, Wake Forest University School of Medicine, E-112, NRC, 1 Medical Center Blvd, Winston-Salem, NC, 27157, USA.
Jessica R OverbeyDepartment of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA.
Kelly WangDepartment of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA.
Denise FaustSection On Gastroenterology & Hepatology, Department of Internal Medicine, Wake Forest University School of Medicine, E-112, NRC, 1 Medical Center Blvd, Winston-Salem, NC, 27157, USA.
Csilla HallbergDivision of Gastroenterology & Hepatology, Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX, 77555-0655, USA.
Karli HedstromDepartment of Human Genetics & Genomics, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA.
Hetanshi NaikDepartment of Human Genetics & Genomics, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA.
Akshata MogheDivision of Gastroenterology & Hepatology, Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX, 77555-0655, USA.
Karl E AndersonDivision of Gastroenterology & Hepatology, Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX, 77555-0655, USA.
Icahn School of Medicine at Mount Sinai · USWake Forest University · USThe University of Texas Medical Branch at Galveston · US

Funding

Wake Forest Clinical and Translational Science AwardUL1TR001420 · NCATS · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI ARD, JAMY D, FOLEY, KRISTIE L · 2015 to 2023
$32.3M
Porphyrias Consortium: SupplementU54DK083909 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI BALWANI, MANISHA, DESNICK, ROBERT J · 2009 to 2023
$18.5M
UTMB CLINICAL AND TRANSLATIONAL SCIENCE AWARD: NASA BED REST STUDIESUL1RR029876 · NCRR · UNIVERSITY OF TEXAS MED BR GALVESTON · PI BRASIER, ALLAN R. · 2009 to 2011
$17.7M
NCATS NIH HHS UL1 TR001420NCRR NIH HHS UL1 RR029876NIDDK NIH HHS U54 DK083909
6 · The paper itself

Abstract

BACKGROUND AND

aimsChronic hepatitis C [CHC] is a risk factor for porphyria cutanea tarda [PCT]. To assess whether ledipasvir/sofosbuvir is effective for treating both PCT and CHC, we treated patients with CHC + PCT solely with ledipasvir/sofosbuvir and followed them for at least 1 year to assess cure of CHC and remission of PCT.

methodsBetween September 2017 and May 2020, 15 of 23 screened PCT + CHC patients were eligible and enrolled. All were treated with ledipasvir/sofosbuvir at recommended doses and durations, according to their stage of liver disease. We measured plasma and urinary porphyrins at baseline and monthly for the first 12 months and at 16, 20, and 24 mos. We measured serum HCV RNA at baseline, 8-12, and 20-24 mos. Cure of HCV was defined as no detectable serum HCV RNA ≥ 12 weeks after the end of treatment (EOT). Remission of PCT was defined clinically as no new blisters or bullae and biochemically as urinary uro- plus hepta-carboxyl porphyrins ≤ 100 mcg/g creatinine.

resultsAll 15 patients, 13 of whom were men, were infected with HCV genotype 1. 2/15 withdrew or were lost to follow-up. Of the remaining 13, 12 achieved cure of CHC; 1 had complete virological response, followed by relapse of HCV after ledipasvir/sofosbuvir but was subsequently cured by treatment with sofosbuvir/velpatasvir. Of the 12 cured of CHC, all achieved sustained clinical remission of PCT.

conclusionsLedipasvir/sofosbuvir [and likely other direct-acting antivirals] is an effective treatment for HCV in the presence of PCT and leads to clinical remission of PCT without additional phlebotomy or low-dose hydroxychloroquine treatment.

trial registrationClinicalTrials.gov NCT03118674.

Indexed as

Hepatitis C, ChronicPorphyria Cutanea TardaPorphyrinsAntiviral AgentsBenzimidazolesDrug Therapy, CombinationFemaleFluorenesGenotypeHepacivirusHumansMaleRNASofosbuvirTreatment OutcomeAntiviral AgentsBenzimidazolesFluorenesledipasvirledipasvir, sofosbuvir drug combinationPorphyrinsRNASofosbuvirCutaneous porphyriasDirect-acting antivirals against hepatitis CHarvoniLedipasvir/sofosbuvirSustained virological responseUroporphyria

Identifiers

PMID36811718
PMCPMC9945827
OpenAlexW4321502428

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.