human immunodeficiency virus patients: the experience of the scolta project

POSTER PRESENTATIONS were collected at baseline (T0), at the first month (T1), at the end of treatment (T2) and 3 months after treatment ending (T3). In subjects without a clear diagnosis of cirrhosis liver stiffness by fibroscan was performed a T0 and T3. A group of 12 healthy subjects were considered as control group. Results: We enrolled 41 patients: 28 A: median age 58.5 ± 9.7 yrs, 77% male, 88% Metavir F4 of these 67% Child-Pugh A5; 13 group B: median age 62.6 ± 7.7 yrs, 77% male, 39% Metavir F4 of these 100% Child-Pugh A5. Results are reported for T0 and T1 as the study is ongoing. sCD14 levels were similar between group A and group B ( p = 0.46) but significantly higher in comparison with healthy controls ( p < 0.00001). Baseline sCD14 levels significantly correlated with GOT (r = 0.390, p = 0.015), GPT (r = 0.335, p = 0.046). We did not found any correlation with HCV-RNA levels at baseline, neither with the degree of liver stiffness. At T1, 89% of A patients and 54% of B patients cleared HCV. sCD14 levels decrease significantly, in group A ( p = 0.001) but not in group B ( p = 0.345). sCD14 levels in both groups were still significantly higher than those of healthy individuals ( p < 0,0001). Conclusions: Immuno-activation assessed by sCD14 is elevated in patients with HCV infection suggesting that it could be a useful markers in cirrhotic patients. After one month of DAAs treatment, sCD14 level decreases significantly, but is still not normalized, in HCV patients with advanced fibrosis. These changes are less evident in transplanted patients with HCV recurrence. THU-231 Current treatment options for hepatitis C virus/human immunodeficiency virus patients: the experience of the scolta project B. Menzaghi1, E. Ricci2, C. Magni2, G. Parruti3, L. Nicolini4, G. Cenderello5, F. Peruzzu6, M. Gussio7, R. Gulminetti8, P. Bonfanti9. 1 Unit of Infectious Disease, Asst Valle Olona, Busto Arsizio; 2Infectious Diseases, Asst Fatebenefratelli Sacco, Milano; 3Infectious Diseases, Pescara Hospital, Pescara; 4Infectious Diseases, San Martino Hospital; 5 Infectious Diseases, Galliera Hospital, Genoa; 6Infectious Diseases, University of Sassari, Sassari; 7Infectious Diseases, Garibaldi Hospital, Catania; 8Infectious Diseases, IRCCS Policlinico San Matteo, Pavia; 9 Infectious Diseases, Manzoni Hospital, Lecco, Italy E-mail: [email protected] Background and Aims: There are few data on the real-world experience of oral hepatitis C virus (HCV) direct-acting antiviral (DAA) drug combinations in HIV/HCV coinfected patients ( pts). The aim of this study is to evaluate the safety and the efficacy of DAA therapies in a cohort of HIV/HCV patients. Methods: The SCOLTA HCV project (Surveillance Cohort Long-Term Toxicity of Antiretrovirals/Antivirals) is an observational, prospective, multicenter cohort study enrolling HCV pts, both mono- and coinfected with HIV, who started DAA treatment. Pts were treated according to Italian guidelines. Results: Overall 1303 pts (30.7% HCV/HIV) were included in this study. 68.7% were males; median age was 54.0 years. Among them, 62.4% had F4 and 27.2% F3 fibrosis. HCV/HIV and HCV pts were similar in terms of baseline fibrosis. HCV/HIV subjects were younger, more frequently males and harbored more frequently HCV genotype 1a or 3. Patients with HCV genotype 1 infection received more frequently SOF/LDV instead of 3D or SOF/SIM in case of HIV coinfection. Sustained virological response (SVR12) was evaluable for 1022 pts (78.5%) and has been achieved in 93.3% of them. Excluding pts who prematurely discontinued treatment (n = 10, 1.0%, 7 due to adverse events, 3 to death), SVR12 rate was 92.4% and 95.2% in HCV/HIV and HCV pts, respectively ( p = 0.07). According to genotype, SVR12 was 97.2% in 1a, 96.1% in 1b, 93.8% in 2, 87.9% in 3 and 92.6% in 4 ( p = 0.0004). The analyses were conducted in strata of HCV genotype. Including in the logistic regression terms for gender, age, baseline HCVRNA and DAA regimen, HIV co-infection was not associated to a worse

virological outcome (both in the per-protocol and intention-to-treat analysis). In genotype 3, SOF/DAC regimen (with or without ribavirine) was protective against failure (OR = 0.32, 95% CI 0.11–0.96) as compared to SOF/RIBA. In genotype 4, as compared to SOF/LDV, SOF/ SIM and 2D were less likely to experience failure (respectively OR 0.03, 95% CI 0.01–0.40 and OR 0.01, 95% CI 0.01–0.57).

Baseline characteristics Females Median age (min-max) METAVIR score F0–F2 F3 F4 Genotype 1a 1b 2 3 4 HCVRNA T0 > 800,000 UI/mL Undetectable HCVRNA 4 wks Ribavirine DAA regimen 2D 3D SIM/DAC SIM/PEG SOF/RIBA SOF/DAC SOF/LED SOF/SIM Outcome SVR 12 Failure Relapse Interruption

HCV n (902, 69.3%)

HCV/HIV n (400, 30.7%)

P

316 (35.0) 56 (25–87)

66 (16.5) 52 (34–76)

<0.0001 <0.0001 0.17

100 (11.5) 232 (26.7) 538 (61.8)

30 (8.0) 107 (28.5) 239 (63.5)

164 (18.2) 403 (44.6) 107 (11.8) 123 (13.6) 106 (11.7) 422 (46.8)

161 (40.2) 55 (13.8) 4 (1.0) 118 (29.5) 62 (15.5) 222 (30.7)

0.004

373 (48.5)

152 (49.0)

0.86

609 (67.5)

273 (68.2)

0.80 <0.0001

34 (3.8) 189 (21.4) 4 (0.4) 26 (2.9) 178 (20.1) 108 (12.2) 124 (14.0) 222 (25.1)

22 (5.6) 54 (13.7) 0 3 (0.8) 82 (20.9) 77 (19.6) 82 (20.9) 73 (18.6)

652 (94.1) 8 (1.2) 25 (3.6) 8 (1.2)

302 (91.8) 8 (2.4) 17 (5.2) 2 (0.6)

<0.0001

0.19

Conclusions: HIV co-infection did not affect the outcome of HCV treatment in a real life cohort. In this study, we confirmed that genotype 3 HCV was associated with a lower SVR to DAA treatment. In real life, high and similar rates of SVR were observed between monoand co-infected pts. SOF/DAC in genotype 3 and SOF/SIM and 2D in 4 were associated to better SVR, but because of the low number of failures this finding needs to be confirmed. THU-232 The path towards hepatitis C elimination in Australia following universal access to interferon-free treatments B. Hajarizadeh1, J. Grebely1, G.V. Matthews1, M. Martinello1, G.J. Dore1. 1 The Kirby Institute, UNSW Australia (University of New South Wales), Sydney, Australia E-mail: [email protected] Background and Aims: Australia has established a foundation for achieving WHO hepatitis C virus (HCV) elimination targets, through a high HCV diagnosis rate (82%), and government-funded direct acting antiviral (DAA) treatment without restrictions by liver disease stage, drug/alcohol use, or prescriber type (since March 2016). This study assessed DAA treatment uptake and patterns to evaluate whether early trends support HCV elimination. Methods: Data from Pharmaceutical Benefits Scheme (PBS) on DAA prescriptions processed for reimbursement and the data on total drug sale expenditure for dispensed and reimbursed DAA regimens during March–July 2016 were used to estimate the overall treatment uptake. For gender-, age-, and prescriber-specific analysis, data on a

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