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Efficacy, safety and patient-reported outcomes of ledipasvir/sofosbuvir in NS3/4A protease inhibitor-experienced individuals with hepatitis C virus genotype 1 and HIV coinfection with and without cirrhosis (ANRS HC31 SOFTRIH study).

Efficacy, safety and patient-reported outcomes of ledipasvir/sofosbuvir in NS3/4A protease inhibitor-experienced individuals with hepatitis C virus genotype 1 and HIV coinfection with and without cirrhosis (ANRS HC31 SOFTRIH study).
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Rosenthal E, Fougerou-Leurent C, Renault A, Carrieri MP, Marcellin F, Garraffo R, Teicher E, Aumaitre H, Lacombe K, Bailly F, Billaud E, Chevaliez S, Dominguez S, Valantin MA, Reynes J, Naqvi A, Cotte L, Metivier S, Leroy V, Dupon M, Allegre T, De Truchis P, Jeantils V, Chas J, Salmon-Ceron D, Morlat P, Neau D, Perré P, Piroth L, Pol S, Bourlière M, Pageaux GP, Alric L, Zucman D, Girard PM, Poizot-Martin I, Yazdanpanah Y, Raffi F, Pabic EL, Tual C, Pailhé A, Amri I, Bellissant E, Molina JM, ,


Rosenthal E, Fougerou-Leurent C, Renault A, Carrieri MP, Marcellin F, Garraffo R, Teicher E, Aumaitre H, Lacombe K, Bailly F, Billaud E, Chevaliez S, Dominguez S, Valantin MA, Reynes J, Naqvi A, Cotte L, Metivier S, Leroy V, Dupon M, Allegre T, De Truchis P, Jeantils V, Chas J, Salmon-Ceron D, Morlat P, Neau D, Perré P, Piroth L, Pol S, Bourlière M, Pageaux GP, Alric L, Zucman D, Girard PM, Poizot-Martin I, Yazdanpanah Y, Raffi F, Pabic EL, Tual C, Pailhé A, Amri I, Bellissant E, Molina JM, , (click to view)

Rosenthal E, Fougerou-Leurent C, Renault A, Carrieri MP, Marcellin F, Garraffo R, Teicher E, Aumaitre H, Lacombe K, Bailly F, Billaud E, Chevaliez S, Dominguez S, Valantin MA, Reynes J, Naqvi A, Cotte L, Metivier S, Leroy V, Dupon M, Allegre T, De Truchis P, Jeantils V, Chas J, Salmon-Ceron D, Morlat P, Neau D, Perré P, Piroth L, Pol S, Bourlière M, Pageaux GP, Alric L, Zucman D, Girard PM, Poizot-Martin I, Yazdanpanah Y, Raffi F, Pabic EL, Tual C, Pailhé A, Amri I, Bellissant E, Molina JM, ,

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HIV medicine 2017 12 07() doi 10.1111/hiv.12571

Abstract
OBJECTIVES
Studies evaluating the efficacy and safety of the fixed-dose combination ledipasvir (LDV)/sofosbuvir (SOF) in patients coinfected with HIV-1 and hepatitis C virus (HCV) have mainly included treatment-naïve patients without cirrhosis. We aimed to evaluate the efficacy and safety of this combination in treatment-experienced patients with and without cirrhosis.

METHODS
We conducted a multicentre, open-label, double-arm, nonrandomized study in patients coinfected with HIV-1 and HCV genotype 1 with and without cirrhosis, who had good viral suppression on their antiretroviral regimens. All patients were pretreated with a first-generation NS3/4A protease inhibitor (PI) plus pegylated interferon/ribavirin. Patients received a fixed-dose combination of LDV/SOF for 12 weeks, or for 24 weeks if cirrhosis was present. The primary endpoint was a sustained virological response (SVR) 12 weeks after the end of therapy. Secondary endpoints included safety, pharmacokinetics and patient-reported outcomes.

RESULTS
Of the 68 patients enrolled, 39.7% had cirrhosis. Sixty-five patients [95.6%; 95% confidence interval (CI): 87.6-99.1%; P < 0.0001] achieved an SVR, with similar rates of SVR in those with and without cirrhosis. Tolerance was satisfactory, with mainly grade 1 or 2 adverse events. Among patient-reported outcomes, only fatigue significantly decreased at the end of treatment compared with baseline [odds ratio (OR): 0.36; 95% CI: 0.14-0.96; P = 0.04]. Mean tenofovir area under the plasma concentration-time curve (AUC) at week 4 was high, with mean ± SD AUC variation between baseline and week 4 higher in cirrhotic than in noncirrhotic patients (3261.57 ± 1920.47 ng/mL vs. 1576.15 ± 911.97 ng/mL, respectively; P = 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. CONCLUSIONS
LDV/SOF provided a high SVR rate in PI-experienced subjects coinfected with HCV genotype 1 and HIV-1, including patients with cirrhosis.

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