Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant

Inclusion Criteria

• •The intent of the Retrospective Arm is to capture all HIV/HCV coinfected patients exposed to sofosbuvir based DAA therapy since 2014, to mirror the population enrolled in the Prospective Arm.
• •Liver transplant candidates (listed) and decompensated cirrhotics (not listed) for liver transplant
• •1. Treated with sofosbuvir based DAA for any duration since 2014
• •2. Age \>18 years at time of treatment
• •3. Pre-treatment Child's Pugh score of 7 or greater
• •4. Pre-treatment laboratory MELD \>=6 and \<=0
• •5. Survived at least 12 weeks after start of treatment
• •6. HIV-positive on stable ART for at least 4 weeks pre-treatment
• •7. Chronic HCV infection with at least one measurement of plasma HCV RNA \>= 1,000 IU/mL prior to treatment with sofosbuvir based DAA therapy
• •8. HCV genotype 1, 4, 5 or 6
• •Liver transplant recipients
• •1. Treated with sofosbuvir based DAA post liver transplant for any duration since 2014
• •2. Liver transplant from 2000 to current
• •3. Age \>18 years at time of treatment
• •4. Treated initiated at least 1 month post-liver transplant
• •5. Post-LT stage of liver disease documented within the prior year of treatment start date by standard of care methods of liver staging
• •6. Survived at least 12 weeks after start of treatment
• •7. HIV-positive on stable ART for at least 4 weeks pre-treatment
• •8. Chronic HCV infection with at least one measurement of plasma HCV RNA \>= 1,000 IU/mL prior to treatment with sofosbuvir based DAA therapy
• •9. Fibrosis staging done within 1 year of start of DAA therapy
• •10. HCV genotype 1, 4, 5 or 6
• •1. Over 18 years of age at screening
• •2. Female participants of child bearing potential must have a negative urine pregnancy test at day 0 prior to dosing.
• •3. Has received a liver transplant for HCV or has decompensated cirrhosis (Child's Pugh score of 7 or greater)
• •4. Have HIV-1 infection and either:
• •1. On HIV medications (antiretrovirals) for at least 4 weeks WITH
• •* An HIV viral load less than the level of detection OR
• •2. On no HIV medications for at least 8 weeks WITH:
• •* A CD4 count of 500 cells/mm3 or more OR
• •* HIV viral load of \< 500 copies/mL with a stable CD4 count for at least 3 months
• •5. Chronic HCV infection as documented by at least one measurement of plasma HCV RNA \>= 1,000 IU/mL during screening and at least one of the following:
• •A positive anti-HCV antibody, HCV RNA, or an HCV genotype test at least 12 months prior to baseline (Day 0) visit together with positive HCV RNA test
• •6. HCV genotype 1, 4, 5 or 6
• •7. The use of an anti-HCV positive donor is allowed for participants who have detectable HCV RNA at the time of transplant.
• •8. The use of an HIV+ donor is allowed if the participant is enrolled in an IRB approved HOPE Act protocol at the transplant site. If the HIV+ donor is also HCV co-infected, then the recipient must have detectable HCV RNA at the time of transplant.
• •9. Able to effectively communicate with the Investigator and other center personnel.
• •10. Willing to give written informed consent and comply with the study restrictions and requirements.
• •11. Willingness to allow stored blood or tissue samples to be used in the future for studying liver disease and immune function.
• •12. Willingness to permit HLA typing to be performed.
• •13. Have a transplant team available for all primary and transplant-related care.
• •14. If not yet transplanted: expected to be at least 12 weeks prior to transplant in order to complete treatment course.
• •15. If not yet transplanted: Must have prior standard of care liver staging consistent with F4.
• •16. If not yet transplanted: For pre-LT patients with HCC, they must meet Milan criteria at time of enrollment to be eligible
• •17. If post-liver transplant, must be at least 1 month since transplant procedure to begin treatment.
• •18. If post-liver transplant, liver disease staging must be documented within the prior year by standard of care methods of liver staging