CROI 2015 Program and Abstracts

Abstract Listing

Poster Abstracts

Conclusions: Through leveraging evolutionarily restricted regions in the HCV protease robust inhibitors can be designed to increase the barrier to resistance

THURSDAY, FEBRUARY 26, 2015 Session P-N9 Poster Session

Poster Abstracts

Poster Hall

2:30 pm– 4:00 pm Mental Health and Treatment Adherence with Direct-Acting Antivirals 694 Impact of Baseline Mental Health on Adherence to Interferon-Free HCV Therapy

Jack Masur 1 ; LydiaTang 1 ; Amy Nelson 1 ; Anu Osinusi 1 ; Anita Kohli 2 ; Rachel Silk 2 ; Chloe Gross 2 ; Sarah Kattakuzhy 2 ; Michael Polis 3 ; Shyam Kottilil 1 1 University of Maryland, Baltimore, MD, US; 2 National Institutes of Health, Bethesda, MD, US; 3 National Institutes of Health, Bethesda, MD, US

Background: Mental health disorders (MHD) have long presented a barrier to treatment for individuals with chronic hepatitis C (HCV) infections. The complexity and side effect profile of interferon based therapies make many patients with MHD ineligible or unwilling to be treated. Directly acting antiviral therapy is replacing interferon based HCV therapy. This study aims to determine the impact of baseline MHD on adherence and effectiveness of the IFN and RBV free regimen ledipsavir/sofosbuvir (LDV/SOF) in HIV negative and positive hepatitis C patients. Methods: Two NIAID clinical trials, SYNERGY A (HCV mono-infected, n=20) and ERADICATE (HIV/HCV co-infected; ARV naïve n=13, on cART n=37), treated HCV genotype-1, treatment naïve study subjects with a fixed dose combination of ledipsavir (90mg) and sofosbuvir (400mg) daily for 12 weeks. We identified all participants with a baseline MHD defined as a major DSM-IV diagnosis such as major depression, bipolar disorder, schizophrenia, generalized anxiety, post-traumatic stress disorder (PTSD), and depression with anxiety or those requiring anti-depressants, antipsychotics, mood stabilizers or psychotropics. Adherence was measured using medication event monitoring systems (MEMS) caps. Serial measurements of plasma HCV RNA levels were performed using the Roche RealTime HCV RNA assay. Results: Of 20 participants in SYNERGY A, 7 (40%) met the criteria for significant baseline MHD. The prevalence of disorders was as follows: depression (15%), depression with anxiety (15%), bipolar disorder (5%), PTSD (5%), and schizophrenia (5%). Of 50 participants in ERADICATE, 15 (30%) met the criteria for significant baseline MHD. The prevalence of disorders was as follows: depression (16%), bipolar disorder (10%), PTSD (6%), and anxiety (2%). There was no significant difference in adherence to MEMS between MHD patients and non-MHD patients in either study (96% vs. 97% for SYNERGY and 97% vs. 97% for ERADICATE, p.0.05 for both) (Figure 1a, p>0.05). There was no significant difference between MHD patients and non-MHD patients who achieved SVR12 for SYNERGY and SVR4 for ERADICATE (100% vs. 100% for SYNERGY and 100% vs. 97% for ERADICATE, p>0.05 for both) (Figure 1b).

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CROI 2015