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Treatment of acute hepatitis C genotypes 1 and 4 with 8 weeks of grazoprevir plus elbasvir (DAHHS2): an open-label, multicentre, single-arm, phase 3b trial

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dc.contributor.author Boerekamps, A. en_US
dc.contributor.author De Weggheleire, A. en_US
dc.contributor.author van den Berk, G. E. en_US
dc.contributor.author Lauw, F. N. en_US
dc.contributor.author Claassen, M. A. A. en_US
dc.contributor.author Posthouwer, D. en_US
dc.contributor.author Bierman, W. F. en_US
dc.contributor.author Hullegie, S. J. en_US
dc.contributor.author Popping, S. en_US
dc.contributor.author van de Vijver, D. A. C. M. en_US
dc.contributor.author Dofferhoff, A. S. M. en_US
dc.contributor.author Kootstra, G. J. en_US
dc.contributor.author Leyten, E. M. en_US
dc.contributor.author den Hollander, J. en_US
dc.contributor.author van Kasteren, M. E. en_US
dc.contributor.author Soetekouw, R. en_US
dc.contributor.author Ammerlaan, H. S. M. en_US
dc.contributor.author Schinkel, J. en_US
dc.contributor.author Florence, E. en_US
dc.contributor.author Arends, J. E. en_US
dc.contributor.author Rijnders, B. J. A. en_US
dc.date.accessioned 2019-06-04T12:10:05Z
dc.date.available 2019-06-04T12:10:05Z
dc.date.issued 2019 en_US
dc.identifier.issn 2468-1253 en_US
dc.identifier.doi http://dx.doi.org/10.1016/S2468-1253(18)30414-X en_US
dc.identifier.other ITG-C2A; ITG-C19A; DCS; U-HIVNTD; ITG-STDCLI; JIF; DOI; NOBIT; Abstract; Not available; ITMPUB; DSPACE66; NOBIT en_US
dc.identifier.uri http://hdl.handle.net/10390/10206
dc.description.abstract BACKGROUND: Direct-acting antivirals effectively treat chronic hepatitis C virus (HCV) infection but there is a paucity of data on their efficacy for acute HCV, when immediate treatment could prevent onward transmission. We assessed the efficacy of grazoprevir plus elbasvir treatment in acute HCV infection and investigated whether treatment can be shortened during the acute phase of HCV infection. METHODS: The Dutch Acute HCV in HIV study number 2 (DAHHS2) study was a single-arm, open-label, multicentre, phase 3b trial. Adult patients (>/=18 years) with acute HCV genotype 1 or 4 infection (duration of infection 26 weeks or less, according to presumed day of infection) were recruited at 15 HIV outpatient clinics in the Netherlands and Belgium. All patients were treated with 8 weeks of grazoprevir 100 mg plus elbasvir 50 mg administered as one oral fixed drug combination tablet once daily. The primary efficacy endpoint was sustained virological response at 12 weeks after the end of treatment (SVR12; HCV RNA <15 IU/mL) in all patients who started treatment. Reinfection with a different HCV virus was not considered treatment failure in the primary analysis. This trial is registered with ClinicalTrials.gov, number NCT02600325. FINDINGS: Between Feb 15, 2016, and March 2, 2018, we assessed 146 patients with a recently acquired HCV infection for eligibility, of whom 86 were enrolled and 80 initiated therapy, all within 6 months after infection. All patients who initiated treatment completed treatment and no patients were lost to follow-up. 79 (99%, 95% CI 93-100) of 80 patients achieved SVR12. All 14 patients who were infected with a virus carrying a clinically significant polymorphism in NS5A were cured. If reinfections were considered treatment failures, 75 (94%, 86-98) of 80 patients achieved SVR12. Two serious adverse events not considered related to the treatment were reported (traumatic rectal bleeding and low back surgery). The most common adverse event was a new sexually transmitted infection (19 [24%] of 80 patients). The most common reported possibly drug-related adverse events were fatigue (11 [14%] patients), headache (seven [9%] patients), insomnia (seven [9%] patients), mood changes (five [6%] patients), dyspepsia (five [6%] patients), concentration impairment (four [5%] patients), and dizziness (4 [5%] patients), all of which were regarded as mild by the treating physician. No adverse events led to study drug discontinuation. INTERPRETATION: 8 weeks of grazoprevir plus elbasvir was highly effective for the treatment of acute HCV genotype 1 or 4 infection. The ability to treat acute HCV immediately after diagnosis might help physicians to reach the WHO goal of HCV elimination by 2030. FUNDING: Merck Sharp and Dohme and Health-Holland. en_US
dc.language English en_US
dc.relation.uri http://www.ncbi.nlm.nih.gov/pubmed/30660617 en_US
dc.subject Hepatitis C en_US
dc.subject Viral diseases en_US
dc.subject Acute diseases en_US
dc.subject Treatment en_US
dc.subject Clinical trials en_US
dc.subject Netherlands en_US
dc.subject Belgium en_US
dc.subject Europe-West en_US
dc.title Treatment of acute hepatitis C genotypes 1 and 4 with 8 weeks of grazoprevir plus elbasvir (DAHHS2): an open-label, multicentre, single-arm, phase 3b trial en_US
dc.type Article en_US
dc.citation.issue 4 en_US
dc.citation.jtitle Lancet Gastroenterology & Hepatology en_US
dc.citation.volume 4 en_US
dc.citation.pages 269-277 en_US
dc.citation.abbreviation Lancet Gastroenterol Hepatol en_US


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