High Cure Rates With Grazoprevir-Elbasvir With or Without Ribavirin Guided by Genotypic Resistance Testing Among Human Immunodeficiency Virus/Hepatitis C Virus-coinfected Men Who Have Sex With Men.
Adult
Aged
Amides
Antiviral Agents
/ administration & dosage
Benzofurans
/ administration & dosage
Carbamates
Cyclopropanes
Drug Resistance, Viral
Drug-Related Side Effects and Adverse Reactions
/ epidemiology
HIV Infections
/ complications
Hepacivirus
/ drug effects
Hepatitis C, Chronic
/ complications
Homosexuality, Male
Humans
Imidazoles
/ administration & dosage
Male
Microbial Sensitivity Tests
Middle Aged
Prospective Studies
Quinoxalines
/ administration & dosage
Ribavirin
/ administration & dosage
Sulfonamides
Sustained Virologic Response
Treatment Outcome
Journal
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213
Informations de publication
Date de publication:
01 02 2019
01 02 2019
Historique:
received:
19
03
2018
accepted:
29
06
2018
pubmed:
15
8
2018
medline:
18
3
2020
entrez:
15
8
2018
Statut:
ppublish
Résumé
This study was performed to investigate the efficacy and safety of grazoprevir-elbasvir guided by baseline resistance-associated substitutions (RASs) in the Swiss HCVree Trial. We performed hepatitis C virus (HCV) RNA screening among all men who have sex with men (MSM) enrolled in the Swiss HIV Cohort Study. Individuals with replicating HCV genotype 1 or 4 infection were eligible for grazoprevir-elbasvir treatment. Genotype 1a-infected individuals with baseline RASs and genotype 4-infected individuals with prior failure of HCV treatment received 16 weeks of grazoprevir-elbasvir combined with ribavirin. All other individuals received 12 weeks of grazoprevir-elbasvir alone. Patients reporting unprotected sex with occasional partners were offered a HCV risk reduction-oriented behavioral intervention. We screened 3722 MSM and identified 177 (4.8%) with replicating infection. A total of 122 individuals (3.3%) were eligible for study treatment. Six of 76 patients infected with genotype 1a (7.3%) harbored baseline RASs. Sustained virological response after 12 weeks of follow-up was achieved in 121 patients (99%), including all with genotype 1a infection. Overall, 8 serious adverse events occurred, none of which was related to the study drug. Seventy-five percent of eligible MSM participated in the risk counseling program. Grazoprevir-elbasvir for 12 or 16 weeks, with or without ribavirin, achieved high cure rates and had an excellent safety profile. Unique to other studies, the treatment duration was guided by the presence of baseline RASs among genotype 1a-infected individuals, and the treatment phase was accompanied by an HCV risk reduction-oriented behavioral intervention. This successful population-wide treatment approach lays the groundwork to achieve HCV elimination in coinfected MSM. NCT02785666.
Sections du résumé
Background
This study was performed to investigate the efficacy and safety of grazoprevir-elbasvir guided by baseline resistance-associated substitutions (RASs) in the Swiss HCVree Trial.
Methods
We performed hepatitis C virus (HCV) RNA screening among all men who have sex with men (MSM) enrolled in the Swiss HIV Cohort Study. Individuals with replicating HCV genotype 1 or 4 infection were eligible for grazoprevir-elbasvir treatment. Genotype 1a-infected individuals with baseline RASs and genotype 4-infected individuals with prior failure of HCV treatment received 16 weeks of grazoprevir-elbasvir combined with ribavirin. All other individuals received 12 weeks of grazoprevir-elbasvir alone. Patients reporting unprotected sex with occasional partners were offered a HCV risk reduction-oriented behavioral intervention.
Results
We screened 3722 MSM and identified 177 (4.8%) with replicating infection. A total of 122 individuals (3.3%) were eligible for study treatment. Six of 76 patients infected with genotype 1a (7.3%) harbored baseline RASs. Sustained virological response after 12 weeks of follow-up was achieved in 121 patients (99%), including all with genotype 1a infection. Overall, 8 serious adverse events occurred, none of which was related to the study drug. Seventy-five percent of eligible MSM participated in the risk counseling program.
Conclusions
Grazoprevir-elbasvir for 12 or 16 weeks, with or without ribavirin, achieved high cure rates and had an excellent safety profile. Unique to other studies, the treatment duration was guided by the presence of baseline RASs among genotype 1a-infected individuals, and the treatment phase was accompanied by an HCV risk reduction-oriented behavioral intervention. This successful population-wide treatment approach lays the groundwork to achieve HCV elimination in coinfected MSM.
Clinical Trials Registration
NCT02785666.
Identifiants
pubmed: 30107485
pii: 5071945
doi: 10.1093/cid/ciy547
doi:
Substances chimiques
Amides
0
Antiviral Agents
0
Benzofurans
0
Carbamates
0
Cyclopropanes
0
Imidazoles
0
Quinoxalines
0
Sulfonamides
0
Ribavirin
49717AWG6K
grazoprevir
4O2AB118LA
elbasvir
632L571YDK
Banques de données
ClinicalTrials.gov
['NCT02785666']
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
569-576Investigateurs
A Anagnostopoulos
(A)
M Battegay
(M)
E B
(E)
J B
(J)
D L B
(DL)
H C Bucher
(HC)
A Calmy
(A)
M Cavassini
(M)
A Ciuffi
(A)
G Dollenmaier
(G)
M Egger
(M)
L Elzi
(L)
J S F
(JS)
J Fellay
(J)
H Furrer
(H)
C A Fux
(CA)
H F G
(HF)
D Haerry
(D)
B Hasse
(B)
H H Hirsch
(HH)
M Hoffmann
(M)
I Hösli
(I)
M Huber
(M)
C Kahlert
(C)
L Kaiser
(L)
O Keiser
(O)
T Klimkait
(T)
R K
(R)
H Kovari
(H)
B Ledergerber
(B)
G Martinetti
(G)
B Martinez de Tejada
(B)
C Marzolini
(C)
K J Metzner
(KJ)
N Müller
(N)
D N
(D)
P Paioni
(P)
G Pantaleo
(G)
M Perreau
(M)
A R
(A)
C Rudin
(C)
A U Scherrer
(AU)
P S
(P)
R Speck
(R)
M S
(M)
P Tarr
(P)
A Trkola
(A)
P Vernazza
(P)
G Wandeler
(G)
R Weber
(R)
S Yerly
(S)
Commentaires et corrections
Type : CommentIn