Sofosbuvir-Velpatasvir Treatment in HIV-HCV Coinfected Patients

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"Explore the results of the ASTRAL-5 study on the efficacy of Sofosbuvir-Velpatasvir treatment in HIV-HCV coinfected patients, including study design, participant characteristics, and outcomes. This phase 3 trial demonstrated promising results in treatment-naive and treatment-experienced individuals with genotypes 1-6 HCV, highlighting the potential benefits of this fixed-dose combination regimen." (287 characters)

  • Sofosbuvir-Velpatasvir
  • HIV-HCV coinfection
  • ASTRAL-5 study
  • Treatment-naive
  • Treatment-experienced
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  1. Treatment Nave and Treatment Experienced, Phase 3 Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5 Source: Wyles D, et al. Clin Infect Dis. 2017;65:6-12.

  2. Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Study Features Design: Single-arm, open-label, multicenter, phase 3 trial of sofosbuvir-velpatasvir in HIV-HCV coinfected treatment-na ve and treatment-experienced patients with genotypes 1-6 HCV Setting: Multiple sites in US Entry Criteria - Chronic HCV GT 1-6 - Age 18 years - HIV coinfection and on stable ART for weeks - CD4 count 100 cells/mm3 and HIV RNA 50 copies/mL - On stable ART for 8 weeks - Prior treatment failure allowed (but no prior NS5A or NS5B) - Patients with compensated cirrhosis allowed Primary End Point: SVR12 Source: Wyles D, et al. Clin Infect Dis. 2017;65:6-12.

  3. Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Study Design Week 0 12 24 HIV-HCV Coinfected Treatment-na ve or Treatment-experienced GT 1, 2, 3, 4, or 6 SVR12 Sofosbuvir-Velpatasvir n = 106 Drug Dosing: Sofosbuvir-velpatasvir (400/100 mg): fixed-dose combination; one pill once daily Source: Wyles D, et al. Clin Infect Dis. 2017;65:6-12.

  4. Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Participants Sofosbuvir-Velpatasvir (n = 106) Baseline Characteristic Age, mean, years (range) Male, n (%) Black race, n (%) 54 (25-72) 91 (86) 48 (45) HCV genotype, n (%) 1a 1b 2 3 4 66 (62) 12 (11) 11 (10) 12 (11) 5 (5) IL28B non-CC, n (%) Mean HCV RNA, log10 IU/mL (range) Cirrhosis, n (%) Treatment experienced, n (%) 82 (77) 6.3 (5.0-7.4) 19 (18) 31 (29) Source: Wyles D, et al. Clin Infect Dis. 2017;65:6-12.

  5. Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Participants Sofosbuvir-Velpatasvir (n = 106) HIV Baseline Characteristics Mean CD4 cell count, (range) 598 (183-1513) Nucleos(t)ide pair TDF with boosted agent (Ritonavir or Cobicistat) TDF without boosted agent Abacavir-lamivudine 56 (53) 35 (33) 15 (14) Other antiretroviral agent(s) Protease Inhibitor (DRV, LPV, or ATV) NNRTI (RPV) Integrase inhibitor (RAL or EVG) Other (>1 of above classes) 50 (47) 13 (12) 36 (34) 7 (7) Abbreviations: TDF, Tenofovir disoproxil fumarate; RTV, ritonavir; DRV, darunavir; LPV, lopinavir; ATV, atazanavir; RPV, rilpivirine; RAL, raltegravir; EVG, elvitegravir Source: Wyles D, et al. Clin Infect Dis. 2017;65:6-12.

  6. Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Results SVR12 Results by Genotype 100 100 100 95 95 92 92 Patients with SVR12 (%) (95% CI, 72-100) (95% CI, 48-100) 80 (95% CI, 87-99) (95% CI, 89-99) (95% CI, 62-100) (95% CI, 62-100) 60 40 20 101/106 63/66 11/12 11/11 11/12 5/5 0 Overall 1a 1b 2 3 4 HCV Genotype Source: Wyles D, et al. Clin Infect Dis. 2017;65:6-12.

  7. Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Results SVR12 Results by Genotype 100 100 100 95 95 92 92 Patients with SVR12 (%) 80 60 40 2 Relapses 1 LTFU 1 Withdrew Consent 1 LTFU 20 63/66 11/12 11/12 101/106 5/5 11/11 0 Overall 1a 1b 2 3 4 HCV Genotype Source: Wyles D, et al. Clin Infect Dis. 2017;65:6-12.

  8. Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Results SVR12 Results by Treatment Experience and Cirrhosis Status 100 100 97 Patients with SVR12 (%) 95 94 93 80 60 40 20 101/106 71/75 30/31 82/87 19/19 0 210/218 139/144 42/44 27/28 All Na ve Experienced No cirrhosis Cirrhosis TreatmentExperience CirrhosisStatus Source: Wyles D, et al. Clin Infect Dis. 2017;65:6-12.

  9. Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Resistance Response to Treatment (SVR12) Baseline Resistance-Associated Variants (RAVs) No NS5A RAVs NS5A RAVs 100 100 98 Patients with SVR12 (%) 80 60 87% 13% (n = 13) 40 (n = 90 20 88/90 13/13 0 No NS5A RAVs NS5A RAVs Source: Wyles D, et al. Clin Infect Dis. 2017;65:6-12. 9

  10. Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Tenofovir Pharmacokinetics Mean (%CV) PK Parameters of Tenofovir by Boosted or Unboosted ART Regimen Sofosbuvir-Velpatasvir + Unboosted Tenofovir DF-Containing Regimens (n = 35) Sofosbuvir-Velpatasvir + Boosted Tenofovir DF-Containing Regimens (n = 56) Tenofovir PK Parameter AUCtau(h ng/mL) 3590 (23.2) 3740 (26.3) Cmax (ng/mL) 319 (26.4) 351 (30.8) Ctau (ng/mL) 91.2 (37.9) 92.9 (41.4) Source: Wyles D, et al. Clin Infect Dis. 2017;65:6-12.

  11. Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Adverse Events Sofosbuvir-Velpatasvir (n = 106) Adverse Event (AE), n (%) Discontinuation due to AE 2 (2) Serious AEs 2 (2) Deaths 0 Any AE in >5% of patients Fatigue Headache Arthralgia Upper respiratory tract infection Diarrhea Insomnia Nausea 26 (25) 14 (13) 9 (8) 9 (8) 9 (8) 7 (7) 7 (7) The majority of AEs were mild in severity (grade 1 or 2) No patient with confirmed on-treatment HIV virologic breakthrough Source: Wyles D, et al. Clin Infect Dis. 2017;65:6-12.

  12. Sofosbuvir-Velpatasvir in HIV-HCV Coinfected Patients ASTRAL-5: Conclusions Conclusions: Sofosbuvir-velpatasvir for 12 weeks was safe and provided high rates of SVR12 in patients coinfected with HCV and HIV-1. Source: Wyles D, et al. Clin Infect Dis. 2017;65:6-12.

  13. Acknowledgments Hepatitis C Online is funded by a cooperative agreement from the Centers for Disease Control and Prevention (CDC-RFA- PS21-2105). This project is led by the University of Washington Infectious Diseases Education and Assessment (IDEA) Program. The contents in this presentation are those of the author(s) and do not necessarily represent the official position of views of, nor an endorsement, by the Centers for Disease Control and Prevention.

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