CROI 2015 Program and Abstracts

Abstract Listing

Poster Abstracts

Conclusions: Since 31% of our study subjects had serious, controlled MHD when starting therapy, it appears that controlled major psychiatric disorders may be no barrier to the successful completion of anti-HCV therapy using a newer DAA combination. 695 Mental Health Impact of HCV Treatment in HIV/HCV Patients: DAA vs IFN-Based Therapy Louise Lundgren 1 ; Sarah Kattakuzhy 2 ; Angie Price 2 ; Catherine Seamon 3 ; Amy Nelson 4 ; Anita Kohli 2 ; Rachel Silk 2 ; Chloe Gross 2 ; Henry Masur 1 ; Shyamasundaran Kottilil 4 1 National Institutes of Health Clinical Center, Bethesda, MD, US; 2 Leidos Biomedical Research, Inc, Frederick, MD, US; 3 Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, US; 4 Institute of Human Virology, University of Maryland, Baltimore, MD, US Background: Depression is one of the most important complications of IFN-based chronic hepatitis C treatment, affecting one in four patients. Psychiatric side effects of IFN have significant clinical implications, creating a relative contraindication to IFN in those with mental dissorders. Patients with HIV/HCV-coinfection are particularly vulnerable given the prevalence of psychiatric comorbidities and higher adverse event rates to IFN containing therapy. In phase III studies of HCV treatment utilizing directly acting antivirals (DAA), psychiatric side effects outside of insomnia have not been described. The current analysis seeks to evaluate treatment-induced depression as a complication of HCV therapy in both DAA- and IFN-based regimens. Methods: Beck’s Depression Inventory (BDI) scores from three phase II clinical trials for treatment of HCV in HIV/HCV coinfected patients were retrospectively analyzed. 26 patients were included who were treated with peg-IFN and ribavirin for 48 weeks, while 50 patients were included who were treated with 12 weeks of sofosbuvir/ledipasvir. BDI scores were collected at pre-treatment day 0, during treatment and 1 to 8 weeks post-treatment. Results: Average BDI-scores at day 0 were similar between IFN-based (6.96) and DAA-based (5.38) treatment groups (p=0.34). During IFN treatment, BDI scores rose an average of 2.4 points, while scores declined an average of -2.2 points for patients on DAAs (p=0.001, 95% CI:-7.3 to -1.9). Mean mid-treatment scores varied significantly between IFN and DAA-based therapy, with scores of 9.35 (corresponding to mild-moderate depression) and 3.18 respectively (p=0.001, 95% CI:-9.8 to -2.5). Post treatment, BDI scores in DAA treated patients were significantly lower as compared to patients who received IFN based treatment (p=0.02, 95% CI:-6.4 to -0.5). While post IFN containing treatment BDI scores returned to baseline, scores were significantly lower post DAA treatment compared to pre-therapy(p=.0008, 95% CI:-3.9 to -1.1).

Poster Abstracts

Change in BDI Score During HCV Treatment Conclusions: DAA-based therapy is not complicated by depression while on treatment, and may be the optimal choice for patients with psychiatric comorbidities. The mechanism of BDI score decline in DAA-treated patients post-treatment is unclear. However, given the known improvement in HCV neurocognitive dysfunction after SVR, it is plausible that this result is mediated by the rapid virologic response associated with DAA-based therapy, rather than medication effect, and is likely to be addressed in larger clinical trials.

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CROI 2015