Evidence map›Paper›PMID 28272163›Full record

ArticleJournal of acquired immune deficiency syndromes (1999)2017

Real-World Efficacy of Daclatasvir and Sofosbuvir, With and Without Ribavirin, in HIV/HCV Coinfected Patients With Advanced Liver Disease in a French Early Access Cohort.

Karine Lacombe, Hélène Fontaine, Catherine Dhiver, Sophie Metivier, Eric Rosenthal, Teresa Antonini, Marc Antoine Valantin, Patrick Miailhes, Stanislas Harent, Dominique Batisse and 19 more

Open access · hybridAbstract read
In one paragraph

Article in Journal of acquired immune deficiency syndromes (1999), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
3.6field-weighted citation impact, top 6% 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

17 citing papers in PubMed, 34 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Retrospective-prospective study of safety and efficacy of sofosbuvir-based direct-acting antivirals in HIV/HCV-coinfected participants with decompensated liver disease pre- or post-liver transplant.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2021
    Article
  5. Article
  6. Observational
  7. Review
  8. Article
  9. Review
  10. [Safety and efficacy of DCV-based DAAs therapy for chronic HCV infection in China].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2018
    Article
  11. Review
  12. Article
  13. Observational
  14. Article
  15. When do co-infections matter?Current opinion in infectious diseases · 2018
    Review
  16. [Daclatasvir-sofosbuvir combination therapy for chronic hepatitis C virus infection: progress in clinical studies].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2018
    Article
  17. 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

29 authors at 20 institutions in 2 countries.

Karine Lacombe1Department of Infectious and Tropical Diseases, Hôpitaux Universitaires Saint-Antoine, Assistance Publique Hôpitaux de Paris (APHP), Paris, France; 2Sorbonne Universités, INSERM, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP UMRS 1136), Paris, France; 3Hepatology Unit, Cochin Hospital, APHP, INSERM USM20, Pasteur Institute, Paris, France; 4Department of Infectious Diseases, CHU de la Conception, Marseilles, France; 5Department of Hepato-gastroenterology, CHU Purpan, Toulouse, France; 6Department of Internal Medicine and COREVIH PACA-EST, CHU Archet, Nice, France; 7Hepatobiliary Centre, CHU Paul-Brousse, Villejuif, France; 8Department of Infectious and Tropical Diseases, CHU Pitié-Salpêtrière, Paris, France; 9Department of Infectious and Tropical Diseases, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France; 10Department of Infectious and Tropical Diseases, Bichat-Claude Bernard Hospital, Paris, France; 11Department of Clinical Immunology, Georges-Pompidou European Hospital, Paris, France; 12Department of Hepato-gastroenterology, CHU de Montpellier, Montpellier, France; 13Department of Infectious and Tropical Diseases, Hôpitaux Universitaires Tenon, APHP, Paris, France; 14Department of Infectious and Tropical Diseases, CHU Perpignan, Perpignan, France; 15Department of Clinical Immunology, CHU Henri Mondor, Créteil, France; 16Department of Hemato-oncology, CH Aix-en-Provence, Aix-en-Provence, France; 17Department of Infectious Diseases, CHU Toulon, Toulon, France; 18Department of Infectious and Tropical Diseases, CHU Hôtel Dieu, Nantes, France; 19Department of Infectious Diseases, Raymond Poincaré Hospital, APHP, Garches, France; 20Department of Internal Medicine, CHD La Roche-sur-Yon, La Roche-sur-Yon, France; 21Department of Hepato-gastroenterology, CHU Grenoble Alpes, Grenoble, France; 22Hepatic Fibrosis Investigation Centre, Haut-Lévêque Hospital, CHU de Bordeaux, Pessac, France; 23INSERM U1223, Pasteur Institute, Paris-Descartes University and Hepatology Department, Cochin Hospital, Paris, France; 24INSERM U1219, ISPED University of Bordeaux, Bordeaux, France; 25Bristol-Myers Squibb Research and Development, Princeton, NJ; 26Bristol-Myers Squibb Research and Development, Rueil-Malmaison, Paris, France; and 27Paris Descartes University, Paris, France.
Hélène Fontaine
Catherine Dhiver
Sophie Metivier
Eric Rosenthal
Teresa Antonini
Marc Antoine Valantin
Patrick Miailhes
Stanislas Harent
Dominique Batisse
Georges-Philippe Pageaux
Julie Chas
Hugues Aumaitre
Stephanie Dominguez
Thierry Allegre
Alain Lafeuillade
Eric Billaud
Pierre De Truchis
Philippe Perre
Vincent Leroy
Victor De Ledinghen
Philippe Sogni
François Dabis
Yue Zhao
Anne Filipovics
Larysa Fedchuk
Raoudha Akremi
Yacia Bennai
Dominique Salmon Ceron
Bristol-Myers Squibb (France) · FRAssistance Publique – Hôpitaux de Paris · FRBordeaux Population Health · FRBristol-Myers Squibb (United States) · USCentre Hospitalier Départemental Vendée · FRCentre Hospitalier de Perpignan · FRCentre Hospitalier Universitaire de Bordeaux · FRCentre Hospitalier Universitaire de Grenoble · FRCentre Hospitalier Universitaire de Montpellier · FRCentre Hospitalier Universitaire Henri-Mondor · FRHôpital Bichat-Claude-Bernard · FRHôpital Cochin · FRHôpital de la Conception · FRHôpital de la Croix-Rousse · FRHôpital Européen Georges-Pompidou · FRHôpital Paul-Brousse · FRHôpital Purpan · FRHôpital Raymond-Poincaré · FRHôpitaux Universitaires Paris-Ouest · FRInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEfficacious, well-tolerated, direct antiviral agents have drastically changed the prognosis of hepatitis C virus (HCV) disease, but real-world data for oral treatments are limited in key populations such as HIV/HCV coinfection with advanced liver disease. Daclatasvir (DCV) efficacy and safety was assessed in the French "Autorisation Temporaire d'Utilisation" (ATU) program, providing DCV ahead of market authorization to patients with advanced HCV disease without other treatment options.

methodsThis was a subanalysis of HIV/HCV coinfected ATU patients treated with DCV plus sofosbuvir (SOF). Recommended duration was 24 weeks; addition of ribavirin (RBV) and/or shorter treatment was at the physician's discretion. The primary efficacy analysis was sustained virologic response at posttreatment week 12 (SVR12; modified intention-to-treat). Safety was assessed by spontaneous adverse event reporting.

resultsThe efficacy population (N = 407) was mostly cirrhotic (72%, of whom 18% were decompensated), HCV treatment-experienced (82%), and infected with genotypes 1 (69%), 3 (12%), or 4 (19%). Median CD4 was 555 cells/mm; 95% had HIV RNA <50 copies/mL. Most (74%) were treated for 24 weeks; 14% received RBV. SVR12 was 92% overall (95% confidence interval: 88.6% to 94.0%); 90% (86.4% to 93.2%) in patients with cirrhosis; 95% (88.9% to 97.5%) in patients without cirrhosis. SVR12 was consistent across HCV genotypes and antiretroviral regimens. Among 617 patients with safety data, 7 discontinued for an adverse event and 10 died.

conclusionsDCV+SOF±RBV achieved high SVR12 and was well tolerated in this large real-world cohort of HIV/HCV coinfected patients with advanced liver disease.

Indexed as

AdultAgedAntiviral AgentsCarbamatesCoinfectionDrug-Related Side Effects and Adverse ReactionsFemaleFranceHepatitis C, ChronicHIV InfectionsHumansImidazolesMaleMiddle AgedPyrrolidinesRibavirinAntiviral AgentsCarbamatesdaclatasvirImidazolesPyrrolidinesRibavirinSofosbuvirValine

Identifiers

PMID28272163
PMCPMC5389585
OpenAlexW2594023123

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.