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Use of HCV DAAs with HIV Regimens

This slide presentation discusses the use of direct-acting antiviral (DAA) drugs for the treatment of patients with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) coinfection. It provides recommendations for different HCV genotypes and outlines potential drug-drug interactions with HIV therapies.

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Use of HCV DAAs with HIV Regimens

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  1. Use of HCV DAAs with HIV Regimens Sam Lam, PharmD Annie Vong, PharmD 2/3/2017

  2. Available HCV treatment DAAs • Epclusa (sofosbuvir / velpatasvir) • Harvoni (sofosbuvir / ledipasvir) • Zepatier (grazoprevir / elbasvir) • Viekira (paritaprevir/r / ombitasvir; dasabuvir) • Daklinza (daclatasvir) • Sovaldi (sofosbuvir) • Olysio (simeprevir)

  3. DAAs for Pts With GT1 HCV Infection and HIV Coinfection • No 8-wk regimens recommended in HCV/HIV coinfection • Other recommendations on treatment duration and inclusion of RBV same as for HCV monoinfection *Do not use if Q80K positive. †If pegIFN/RBV experienced, add RBV (recommended) or treat for 24 wks (alternative). ‡If baseline NS5A RAVs, add RBV and treat for 16 wks (alternative). AASLD/IDSA. HCV guidance. July 2016. Slide credit: clinicaloptions.com

  4. DAAs for Pts With GT2-6 HCV Infection and HIV Coinfection • Recommendations same as for HCV monoinfection *Treat for 24 wks with or without RBV if compensated cirrhosis present. †Include RBV and treat for 16 wks in pts with failure to suppress virus or virologic breakthrough on previous pegIFN/RBV. ‡Include RBV for pts with compensated cirrhosis who experienced previous pegIFN/RBV failure. AASLD/IDSA. HCV guidance. July 2016. Slide credit: clinicaloptions.com

  5. DHHS Guidelines: Recommended and Alternative First-line HIV ART Regimens Single-tablet regimens are in bold. *Only for pts who are HLA-B*5701 negative. Only for pts with pre-ART CrCl ≥ 50 mL/min.‡Only for pts with pre-ART CrCl ≥ 70 mL/min. ǁOnly for pts with pre-ART CrCl ≥ 30 mL/min. §Only for pts with pre-ART HIV-1 RNA < 100,000 copies/mL and CD4+ cell count > 200 cells/mm3. DHHS Guidelines. January 2016. Slide credit: clinicaloptions.com

  6. Potential for Drug–Drug Interactions With HCV DAAs 1. Simeprevir [package insert]. 2016. 2. Sofosbuvir [package insert]. 2015. 3. Ledipasvir/sofosbuvir [package insert]. 2016. 4. EASL HCV guidelines. April 2015. 5. Elbasvir/grazoprevir [package insert]. 2016. 6. Yeh WW, et al. International Workshop Clin Pharm HIV/Hep Therapy 2015. Abstract 63. 7. Mogalian E, et al. CROI 2016. Abstract 100. Slide credit: clinicaloptions.com

  7. Recommendations for SOF/VEL Use in HCV/HIV Coinfection AASLD/IDSA. HCV guidance. July 2016. Slide credit: clinicaloptions.com

  8. Recommendations for SOF/LDV Use in HCV/HIV Coinfection AASLD/IDSA. HCV guidance. July 2016. Slide credit: clinicaloptions.com

  9. Recommendations for EBR/GZR Use in HCV/HIV Coinfection • Phase III study of EBR/GZR in HCV/HIV coinfection allowed 3TC, ABC, FTC, TDF, RAL, DTG, RPV[1] • EBR/GZR contraindicated with all boosted ART regimens[2] • Marked increase in GZR exposure (potential for hepatotoxicity) • EFV results in a 80% reduction in GZR exposure, 50% decrease in EBR exposure[3] 1. Rockstroh JK, et al. Lancet HIV. 2015;2:e319-e327. 2. EBR/GZR [package insert]. 3. Yeh WW, et al. International Workshop Clin Pharm HIV/Hep Therapy 2015. Abstract 63. 4. AASLD/IDSA. HCV guidance. July 2016. Slide credit: clinicaloptions.com

  10. Recommendations for OBV/PTV/RTV + DSV Use in HCV/HIV Coinfection • Phase II study of OBV/PTV/RTV + DSV + RBV in HCV/HIV coinfection included pts with ATV- or RAL-based ART only[1] 1. Sulkowski MS, et al. JAMA.2015;313:1223-1231. 2. AASLD/IDSA. HCV guidance. July 2016. Slide credit: clinicaloptions.com

  11. Recommendations for DCV + SOF Use in HCV/HIV Coinfection • Dose adjustment needed for DCV when used with ATV/RTV, EFV, or ETR, but DCV + SOF not coformulated, allowing adjustment of DCV dose AASLD/IDSA. HCV guidance. July 2016. Slide credit: clinicaloptions.com

  12. Summary of DDIs Between HCV and HIV Therapies *No data. Potential interaction may require adjustment to dosage, timing of administration, or monitoring Do not coadminister No clinically significant interaction expected 1. AASLD/IDSA HCV Guidance. July 2016. 2. NY/NJ AETC. 2016. 3. Custodio J, et al. IDWeek 2015. Abstract 727. 4. Liverpool Drug Interactions Group. 5. Wyles D, et al. CROI 2016. Abstract 574. Slide credit: clinicaloptions.com

  13. Resources for DDI Information • University of Liverpool www.hep-druginteractions.org • Specific to antiretroviral interactions • DHHS Guidelines Drug Interaction Tables www.aidsinfo.nih.gov

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