Impact of DAA Uptake in Controlling HCV Epidemic and Modeling Interventions for HCV Elimination Among HIV-infected Persons in San Diego
This is a retrospective and prospective study among people living with HIV (PLWH) that assesses hepatitis C (HCV) treatment uptake during periods before and after direct-acting antivirals (DAA) introduction, and its impact on the HCV epidemic among PLWH.
Approximately fifty HIV/HCV coinfected patients with decompensated liver disease will be enrolled in the study. Ten (up to twenty) subjects will be treated with FDC SOF/LDV (Harvoni) pre or post liver transplant and followed prospectively. Forty + subjects will be enrolled retrospectively with the intent to capture all patients who have been exposed to sofosbuvir based DAA therapies at participating sites since 1/2014, and to mirror the population being enrolled prospectively.
This study will enroll subjects who are at high risk for nonadherence (including active alcohol and/drug use, recent hospitalization for a psychiatric condition, previous nonadherence or missed clinic visits, or transportation issues). This study is evaluating the use of a digital medicines program to help sustain adherence and hopefully increase the chance of a cure. Study subjects will be compensated for their time in the study.
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The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not complete the prescribed duration due to adverse event or any reason other than for non/poor compliance. Subjects will be randomized to 12 or 16 weeks of treatment.
Phase 1 of this study will compare the effectiveness of 3 approved HCV treatment regimens to learn whether they work equally well under real-world conditions. Phase 2 of this study will begin early 2017 and will compare the effectiveness of 2 FDA approved HCV treatments. Patients receiving HCV therapy in community and academic clinics will be offered the opportunity to consent to be randomly assigned to one of three regimens and then observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management will be assumed by usual care conditions, and patient-reported outcomes will be collected outside clinic in keeping with pragmatic design principles.
Mavyret: A Phase 3b, single arm, open-label, multicenter study to evaluate the safety and to demonstrate the non-inferiority of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with the glecaprevir (GLE)/pibrentasvir (PIB) combination regimen to the historical SVR12 rate of 12 weeks of treatment with the GLE/PIB in treatment-naïve adults with chronic HCV GT 1, 2, 4, 5, or 6 infection and compensated cirrhosis.
This project is a randomized clinical trial of two strategies to treat persons with genotype 1 HCV who currently inject drugs (PWIDs) with a once daily regime of ledipasvir-sofosbuvir (LDV-SOF) for 8 weeks. The study will enroll 30 participants and will assess the feasibility and acceptability of treating active PWIDs for HCV with Ledipasvir-sofosbuvir (Harvoni) by modified directly observed therapy (mDOT) versus unobserved dosing, with motivational interviewing based adherence support; and assess through in-depth, semi-structured qualitative interviews, the challenges with time intensity required for mDOT and unobserved dosing interventions, and identify key factors affecting treatment adherence.
Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs (BYE-C)
The study is evaluating the treatment of HCV genotype 1 with the Viekira regime in people coinfected with hepatitis C and HIV. Viekira regime is approved by the Food and Drug Administration (FDA) to treat people mono-infected with HCV and in people coinfected with HCV and HIV. Previous studies have achieved cure rates of 95% to 100%.
Evaluating the Safety and Effectiveness of Interferon-Free Treatment of Hepatitis C Virus Infection in HIV-Coinfected Adults on Antiretroviral Therapy (C_ASCENT)
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The trial will enroll people infected with HCV and people coinfected with HIV/HCV to test the effectiveness of Harvoni treatment to improve central nervous system functioning. The study will use MRI and blood tests to measure the changes the brain.
Impact of Hepatitis C Virus Therapy on Central Nervous System Outcomes
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The study is evaluating the safety and effectiveness of Viekira Pak to treat pediatric patients with chronic hepatitis C genotypes 1 and 4. Viekira Pak is already approved by the Food and Drug Administration to treat adults with hepatitis C. This is the first clinical trial of Viekira Pak to treat pediatric patients.
A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects (ZIRCON)
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