{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T00:57:30Z","timestamp":1789865850147,"version":"4.0.1"},"reference-count":23,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2017,12,7]],"date-time":"2017-12-07T00:00:00Z","timestamp":1512604800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003323","name":"Agence Nationale de Recherches sur le Sida et les H\u00e9patites Virales","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003323","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005564","name":"Gilead Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["HIV Medicine"],"published-print":{"date-parts":[[2018,3]]},"abstract":"Objectives<\/jats:title>Studies evaluating the efficacy and safety of the fixed\u2010dose combination ledipasvir (LDV<\/jats:styled-content>)\/sofosbuvir (SOF<\/jats:styled-content>) in patients coinfected with HIV<\/jats:styled-content>\u20101 and hepatitis C virus (HCV<\/jats:styled-content>) have mainly included treatment\u2010na\u00efve patients without cirrhosis. We aimed to evaluate the efficacy and safety of this combination in treatment\u2010experienced patients with and without cirrhosis.<\/jats:p><\/jats:sec>Methods<\/jats:title>We conducted a multicentre, open\u2010label, double\u2010arm, nonrandomized study in patients coinfected with HIV<\/jats:styled-content>\u20101 and HCV<\/jats:styled-content> genotype 1 with and without cirrhosis, who had good viral suppression on their antiretroviral regimens. All patients were pretreated with a first\u2010generation NS<\/jats:styled-content>3\/4A protease inhibitor (PI<\/jats:styled-content>) plus pegylated interferon\/ribavirin. Patients received a fixed\u2010dose combination of LDV<\/jats:styled-content>\/SOF<\/jats:styled-content> for 12 weeks, or for 24 weeks if cirrhosis was present. The primary endpoint was a sustained virological response (SVR<\/jats:styled-content>) 12 weeks after the end of therapy. Secondary endpoints included safety, pharmacokinetics and patient\u2010reported outcomes.<\/jats:p><\/jats:sec>Results<\/jats:title>Of the 68 patients enrolled, 39.7% had cirrhosis. Sixty\u2010five patients [95.6%; 95% confidence interval (CI<\/jats:styled-content>): 87.6\u201399.1%; P<\/jats:italic> < 0.0001] achieved an SVR<\/jats:styled-content>, with similar rates of SVR<\/jats:styled-content> in those with and without cirrhosis. Tolerance was satisfactory, with mainly grade 1 or 2 adverse events. Among patient\u2010reported outcomes, only fatigue significantly decreased at the end of treatment compared with baseline [odds ratio (OR<\/jats:styled-content>): 0.36; 95% CI<\/jats:styled-content>: 0.14\u20130.96; P<\/jats:italic> = 0.04]. Mean tenofovir area under the plasma concentration\u2013time curve (AUC<\/jats:styled-content>) at week 4 was high, with mean \u00b1 SD AUC<\/jats:styled-content> variation between baseline and week 4 higher in cirrhotic than in noncirrhotic patients (3261.57 \u00b1 1920.47 ng\/mL vs. 1576.15 \u00b1 911.97 ng\/mL, respectively; P<\/jats:italic> = 0.03). Mild proteinuria (54.4%), hypophosphataemia (50.0%), blood bicarbonate decrease (29.4%) and hypokalaemia (13.2%) were reported. The serum creatinine level was not modified.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>LDV<\/jats:styled-content>\/SOF<\/jats:styled-content> provided a high SVR<\/jats:styled-content> rate in PI<\/jats:styled-content>\u2010experienced subjects coinfected with HCV<\/jats:styled-content> genotype 1 and HIV<\/jats:styled-content>\u20101, including patients with cirrhosis.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hiv.12571","type":"journal-article","created":{"date-parts":[[2017,12,7]],"date-time":"2017-12-07T08:52:49Z","timestamp":1512636769000},"page":"227-237","source":"Crossref","is-referenced-by-count":11,"title":["Efficacy, safety and patient\u2010reported outcomes of ledipasvir\/sofosbuvir in NS<\/scp>3\/4A protease inhibitor\u2010experienced individuals with hepatitis C virus genotype 1 and HIV<\/scp> coinfection with and without cirrhosis (ANRS HC<\/scp>31 SOFTRIH<\/scp> study)"],"prefix":"10.1111","volume":"19","author":[{"given":"E","family":"Rosenthal","sequence":"first","affiliation":[{"name":"Internal Medicine Department CHU de Nice H\u00f4pital Archet 1 Nice France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2736-6769","authenticated-orcid":false,"given":"C","family":"Fougerou\u2010Leurent","sequence":"additional","affiliation":[{"name":"Pharmacology Department CHU Rennes Rennes France"},{"name":"Inserm, CIC1414 Rennes France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A","family":"Renault","sequence":"additional","affiliation":[{"name":"Inserm, CIC1414 Rennes France"},{"name":"Pharmacology Laboratory Facult\u00e9 de M\u00e9decine Univ Rennes 1 Rennes France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"MP","family":"Carrieri","sequence":"additional","affiliation":[{"name":"Sciences Economiques & Sociales de la Sant\u00e9 & Traitement de l'Information 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