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Efficacy and safety of the sofosbuvir/velpatasvir combination for the treatment of patients with early mild to moderate COVID-19.
Messina, Vincenzo; Nevola, Riccardo; Izzi, Antonio; De Lucia Sposito, Pellegrino; Marrone, Aldo; Rega, Roberto; Fusco, Raffaele; Lumino, Paolina; Rinaldi, Luca; Gaglione, Pasqualina; Simeone, Filomena; Sasso, Ferdinando Carlo; Maggi, Paolo; Adinolfi, Luigi Elio.
  • Messina V; Infectious Disease Unit, Azienda Ospedaliera Di Caserta S. Anna e S. Sebastiano, Caserta, Italy.
  • Nevola R; Department of Advanced Medical and Surgery Science, Internal Medicine Covid Center, University of Campania Luigi Vanvitelli, 80100, Naples, Italy. riccardo.nevola@unicampania.it.
  • Izzi A; Infectious Diseases, 3Rd Covid Center Ospedale Cotugno, Naples, Italy.
  • De Lucia Sposito P; COVID Center, Ospedale Di Maddaloni, Caserta, Italy.
  • Marrone A; Department of Advanced Medical and Surgery Science, Internal Medicine Covid Center, University of Campania Luigi Vanvitelli, 80100, Naples, Italy.
  • Rega R; Infectious Diseases, 3Rd Covid Center Ospedale Cotugno, Naples, Italy.
  • Fusco R; COVID Center, Ospedale Di Maddaloni, Caserta, Italy.
  • Lumino P; Infectious Diseases, 3Rd Covid Center Ospedale Cotugno, Naples, Italy.
  • Rinaldi L; Department of Advanced Medical and Surgery Science, Internal Medicine Covid Center, University of Campania Luigi Vanvitelli, 80100, Naples, Italy.
  • Gaglione P; COVID Center, Ospedale Di Maddaloni, Caserta, Italy.
  • Simeone F; Infectious Disease Unit, Azienda Ospedaliera Di Caserta S. Anna e S. Sebastiano, Caserta, Italy.
  • Sasso FC; Department of Advanced Medical and Surgery Science, Internal Medicine Covid Center, University of Campania Luigi Vanvitelli, 80100, Naples, Italy.
  • Maggi P; Infectious Disease Unit, Azienda Ospedaliera Di Caserta S. Anna e S. Sebastiano, Caserta, Italy.
  • Adinolfi LE; Department of Advanced Medical and Surgery Science, Internal Medicine Covid Center, University of Campania Luigi Vanvitelli, 80100, Naples, Italy.
Sci Rep ; 12(1): 5771, 2022 04 06.
Article in English | MEDLINE | ID: covidwho-1778635
ABSTRACT
SARS-CoV-2 is still a health problem worldwide despite the availability of vaccines. Therefore, there is a need for effective and safe antiviral. SARS-CoV-2 and HCV necessitate RNA-dependent RNA polymerase (RdRp) for replication; therefore, it has been hypothesized that RdRp inhibitors used to treat HCV may be effective treating SARS-CoV-2. Accordingly, we evaluated the effect of the sofosbuvir/velpatasvir (SOF/VEL) combination in early SARS-CoV-2 infection. A multicenter case-control study was conducted, enrolling 120 patients with mild or moderate COVID-19, of whom 30, HCV coinfected or not, received SOF/VEL tablets (400/100 mg) once daily for 9 days within a median of 6 days from the beginning of infection and 90 controls were treated with standard care. The primary endpoint was the effect on viral clearance, and the secondary endpoint was the improvement of clinical outcomes. Nasal swabs for SARS-CoV-2 by PCR were performed every 5-7 days. Between 5-14 days after starting SOF/VEL treatment, SAS-CoV-2 clearance was observed in 83% of patients, while spontaneous clearance in the control was 13% (p < 0.001). An earlier SARS-CoV-2 clearance was observed in the SOF/VEL group than in the control group (median 14 vs 22 days, respectively, p < 0.001) also when the first positivity was considered. None of the patients in the SOF/VEL group showed disease progression, while in the control group, 24% required more intensive treatment (high flow oxygen or noninvasive/invasive ventilation), and one patient died (p < 0.01). No significant side effects were observed in the SOF/VEL group. Early SOF/VEL treatment in mild/moderate COVID-19 seems to be safe and effective for faster elimination of SARS-CoV-2 and to prevent disease progression.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Hepatitis C / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Sci Rep Year: 2022 Document Type: Article Affiliation country: S41598-022-09741-5

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Hepatitis C / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Sci Rep Year: 2022 Document Type: Article Affiliation country: S41598-022-09741-5