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Your search keyword '"Shafran, S"' showing total 13 results
Start Over Author "Shafran, S" Publisher elsevier b.v.
13 results on '"Shafran, S"'

1. Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-experienced, virologically-suppressed adults living with HIV-1

Author

De Wit, S., Florence, E., Moutschen, M., Van Wijngaerden, E., Vandekerckhove, L., Vandercam, B., Brunetta, J., Conway, B., Klein, M., Murphy, D., Rachlis, A., Shafran, S., Walmsley, S., Ajana, F., Cotte, L., Girardy, P.-M., Katlama, C., Molina, J.-M., Poizot-Martin, I., Raffi, F., Rey, D., Reynes, J., Teicher, E., Yazdanpanah, Y., Gasiorowski, J., Halota, W., Horban, A., Piekarska, A., Witor, A., Arribas, J.R., Perez-Valero, I., Berenguer, J., Casado, J., Gatell, J.M., Gutierrez, F., Galindo, M.J., Gutierrez, M.D.M., Iribarren, J.A., Knobel, H., Negredo, E., Pineda, J.A., Podzamczer, D., Sogorb, J.Portilla, Pulido, F., Ricart, C., Rivero, A., Santos Gil, I., Blaxhult, A., Flamholc, L., Gisslèn, M., Thalme, A., Fehr, J., Rauch, A., Stoeckle, M., Clarke, A., Gazzard, B.G., Johnson, M.A., Orkin, C., Post, F., Ustianowski, A., Waters, L., Bailey, J., Benson, P., Bhatti, L., Brar, I., Bredeek, U.F., Brinson, C., Crofoot, G., Cunningham, D., DeJesus, E., Dietz, C., Dretler, R., Eron, J., Felizarta, F., Fichtenbaum, C., Gallant, J., Gathe, J., Hagins, D., Henn, S., Henry, W.K., Huhn, G., Jain, M., Lucasti, C., Martorell, C., McDonald, C., Mills, A., Morales-Ramirez, J., Mounzer, K., Nahass, R., Olivet, H., Osiyemi, O., Prelutsky, D., Ramgopal, M., Rashbaum, B., Richmond, G., Ruane, P., Scarsella, A., Scribner, A., Shalit, P., Shamblaw, D., Slim, J., Tashima, K., Voskuhl, G., Ward, D., Wilkin, A., de Vente, J., Eron, Joseph J., Orkin, Chloe, Cunningham, Douglas, Pulido, Federico, Post, Frank A., De Wit, Stéphane, Lathouwers, Erkki, Hufkens, Veerle, Jezorwski, John, Petrovic, Romana, Brown, Kimberley, Van Landuyt, Erika, and Opsomer, Magda

Published
2019
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3. Changing HCV patient profiles: insights from a large multinational real-world sofosbuvir/velpatasvir (SOF/VEL) dataset.

Author

Mangia, A., Fagiuoli, S., Di Marco, V., Shafran, S., Khalili, M., Milligan, S., Papatheodoridis, G., Ouzan, D., Rosati, S., Ramji, A., Teti, E., Garcia-Retortillo, M., Hernandez, F. Andres Perez, Wong, A., Fraser, C., Rodriguez-Tajes, S., Mutiloa, E. Jimenèz, Amado, L. Enrique Morano, O'Loan, J., and Campanale, F.

Abstract

The profile of HCV patients being started on direct-acting antivirals (DAAs) has shifted towards more vulnerable populations. This large real-world analysis describes the diverse profile of these populations according to age and sex. Adult HCV patients from 37 clinical cohorts across nine Countries treated with SOF/VEL for 12 weeks without ribavirin were included. Those with a history of decompensation or prior NS5A-inhibitor exposure were excluded. Patients' characteristics, time to treatment, and sustained virological response ≥12 weeks after end of treatment (SVR), stratified by age and sex, were analyzed. Among 6356 patients, 2274 were aged <50 y, 2568 50−65 y, and 1514 > 65 y. Within these age strata, 73%, 65%, and 45%, respectively, were male. Vulnerable populations were well represented, and ∼20% of all patients had a history of IV drug use. Male patients were more likely to have compensated cirrhosis and to be infected with HCV genotype 3. Significantly fewer mental health disorders were seen in male patients. However, use of antipsychotics appeared similar, irrespective of sex. Median TT was shorter in male patients across the age spectrum. In 5845 patients with a valid result, SVR was high across age ranges, with no significant differences observed between males and females (<50 y: female 98.7%, male 99.2%; 50−65 y: female 98.7%, male 98.1%; >65 y: female 99.3%, male 98.3%). 475 pts did not achieve SVR for a non-virological reason: mostly loss to follow-up, with no differences between males and females across age strata. SOF/VEL shows high cure rates across different age and sex groups. Antipsychotic drug use appeared similar in males and females, despite significantly fewer mental health disorders in male pts. TT varied from 1 day to >6 months and was shorter in males. [ABSTRACT FROM AUTHOR]

Published
2023
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10. 1418 DACLATASVIR COMBINED WITH PEGINTERFERON ALFA-2A AND RIBAVIRIN FOR 12 OR 16 WEEKS IN PATIENTS WITH HCV GENOTYPE 2 OR 3 INFECTION: COMMAND GT2/3 STUDY

Author

Dore, G.J., Lawitz, E., H'ezode, C., Shafran, S., Ramji, A., Tatum, H., Taliani, G., Tran, A., Brunetto, M., Zaltron, S., Strasser, S., Weis, N., Ghesquiere, W., Lee, S., Larrey, D., Pol, S., Harley, H., George, J., Fung, S., de L'edinghen, V., Hagens, P., Cohen, D., Cooney, E., Noviello, S., and Hughes, E.

Published
2013
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11. 66 SILEN-C2: SUSTAINED VIROLOGIC RESPONSE (SVR) AND SAFETY OF BI201335 COMBINED WITH PEGINTERFERON ALFA-2A AND RIBAVIRIN (P/R) IN CHRONIC HCV GENOTYPE-1 PATIENTS WITH NON-RESPONSE TO P/R

Author

Sulkowski, M.S., Bourliere, M., Bronowicki, J.-P., Streinu-Cercel, A., Preotescu, L., Asselah, T., Pawlotsky, J.-M., Shafran, S., Pol, S., Caruntu, F.A., Mauss, S., Larrey, D., Häfner, C., Datsenko, Y., Stern, J.O., Kubiak, R., Böcher, W., and Steinmann, G.

Published
2011
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13. Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-experienced, virologically-suppressed adults living with HIV-1

Author

Bailey, J., Ajana, F., Arribas, J.R., Brunetta, J., Halota, W., Raffi, F., Brinson, C., Eron, J., Post, F., Ward, D., Katlama, C., Pineda, J.A., Rauch, A., Vandercam, B., Molina, J.-M., Slim, J., Crofoot, G., Prelutsky, D., Shamblaw, D., Van Wijngaerden, E., Opsomer, M., Pulido, F., Brown, K., Henn, S., Santos Gil, I., Perez-Valero, I., Flamholc, L., Ruane, P., Ricart, C., De Wit, S., Rey, D., Post, F.A., Murphy, D., Negredo, E., Gatell, J.M., Gathe, J., DeJesus, E., Iribarren, J.A., Rashbaum, B., Fehr, J., Dretler, R., Brar, I., Hagins, D., Voskuhl, G., Jain, M., Henry, W.K., Gasiorowski, J., Mills, A., Rivero, A., Van Landuyt, E., Gutierrez, F., Petrovic, R., Gazzard, B.G., Piekarska, A., Walmsley, S., de Vente, J., Girardy, P.-M., Shafran, S., Rachlis, A., Bhatti, L., Knobel, H., Sogorb, J.P., Cunningham, D., Mounzer, K., Klein, M., Galindo, M.J., Clarke, A., Stoeckle, M., Fichtenbaum, C., Dietz, C., EMERALD study group, Olivet, H., Poizot-Martin, I., Nahass, R., Richmond, G., Eron, J.J., Wilkin, A., Benson, P., Morales-Ramirez, J., Lathouwers, E., Lucasti, C., Moutschen, M., Osiyemi, O., Casado, J., Gallant, J., Jezorwski, J., Teicher, E., Cotte, L., Vandekerckhove, L., Podzamczer, D., Gisslen, M., Gutierrez, M.D.M., Bredeek, U.F., Waters, L., Scribner, A., Orkin, C., Conway, B., Yazdanpanah, Y., Felizarta, F., Reynes, J., Johnson, M.A., Ustianowski, A., Thalme, A., Martorell, C., McDonald, C., Tashima, K., Berenguer, J., Florence, E., Huhn, G., Shalit, P., Ramgopal, M., Witor, A., Blaxhult, A., Scarsella, A., Horban, A., and Hufkens, V.

Subjects
3. Good health
Abstract

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in EMERALD (NCT02269917). Virologically-suppressed, HIV-1-positive treatment-experienced adults (previous non-darunavir virologic failure [VF] allowed) were randomized (2:1) to D/C/F/TAF or boosted protease inhibitor (PI) plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) over 48 weeks. At week 52 participants in the boosted PI arm were offered switch to D/C/F/TAF (late-switch, 44 weeks D/C/F/TAF exposure). All participants were followed on D/C/F/TAF until week 96. Efficacy endpoints were percentage cumulative protocol-defined virologic rebound (PDVR; confirmed viral load [VL] ≥50 copies/mL) and VL < 50 copies/mL (virologic suppression) and ≥50 copies/mL (VF) (FDA-snapshot analysis). Of 1141 randomized patients, 1080 continued in the extension phase. Few patients had PDVR (D/C/F/TAF: 3.1%, 24/763 cumulative through week 96; late-switch: 2.3%, 8/352 week 52–96). Week 96 virologic suppression was 90.7% (692/763) (D/C/F/TAF) and 93.8% (330/352) (late-switch). VF was 1.2% and 1.7%, respectively. No darunavir, primary PI, tenofovir or emtricitabine resistance-associated mutations were observed post-baseline. No patients discontinued for efficacy-related reasons. Few discontinued due to adverse events (2% D/C/F/TAF arm). Improved renal and bone parameters were maintained in the D/C/F/TAF arm and observed in the late-switch arm, with small increases in total cholesterol/high-density-lipoprotein-cholesterol ratio. A study limitation was the lack of a control arm in the week 96 analysis. Through 96 weeks, D/C/F/TAF resulted in low PDVR rates, high virologic suppression rates, very few VFs, and no resistance development. Late-switch results were consistent with D/C/F/TAF week 48 results. EMERALD week 96 results confirm the efficacy, high genetic barrier to resistance and safety benefits of D/C/F/TAF.

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