CROI 2017 Abstract e-Book

Abstract eBook

Poster and Themed Discussion Abstracts

Methods: Capillary blood was collected by nursing staff using the Roche Accu-Chek Safety Safe-T-Pro Plus Lancet and the Sarstedt Microvette® 100 K3E following established finger-prick procedure. Venous blood was collected in EDTA tubes. The assay was run blind by laboratory staff. Capillary blood (100μl) was transferred directly to the assay cartridge followed by 1ml Xpert diluent. In parallel, plasma (1.1 ml) separated from venous blood was added to another cartridge without sample diluent. Both cartridges were run on the GeneXpert XVI analyzer according to the manufacturer’s instructions. Serial dilutions (2-5 log10 IU/ml) of plasma from two HCV RNA positive patients (HCV genotype 1a and 3a) were tested in duplicate to verify sensitivity of the 100ul protocol. Results: Of 35 subjects undergoing paired blood collection by finger-prick and venous puncture, 2 were excluded due to insufficient sample and cartridge error, respectively. Of the remaining 33 subjects, 24 were HCV antibody and RNA positive, including 5 that were co-infected with HIV. Their plasma HCV RNA load was median 6.0 log10 IU/ml (IQR 5.5-6.4) and HCV genotypes were 1a, 3a, 1b, and 4. A total of 9 subjects were HCV antibody and RNA negative. In all subjects, results obtained with capillary blood matched those of venous blood, and both were in agreement with the patients’ known HCV status. With the serial dilutions, the assay showed good linearity (R2 ≥0.99) and 100% detection rate at 2 log10 IU/ml. Conclusion: The data support the use of small volume capillary blood for HCV RNA detection by GeneXpert, and provide the evidence base for studies evaluating use as POCT in non-specialist laboratory settings. 550 HIV/HCV COINFECTION IN THE DAA ERA: “EN ROUTE FOR ERADICATION”? Laurent Cotte 1 , Pascal Puglièse 2 , Isabelle Poizot-Martin 3 , Marc-Antoine Valantin 4 , Lise Cuzin 5 , Jacques Reynes 6 , Eric Billaud 7 , Thomas Huleux 8 , Pierre Pradat 1 , for the DatAIDS Study Group 1 Hospices Civils de Lyon, Lyon, France, 2 CHU de Nice, Nice, France, 3 Assistance Publique – Hôpitaux de Marseille, Marseille, France, 4 Assistance Publique - Hôpitaux de Paris, Paris, France, 5 CHU Toulouse, Toulouse, France, 6 CHU de Montpellier, Montpellier, France, 7 CHU de Nantes, Nantes, France, 8 Cntr Hosp de Tourcoing, Tourcoing, France Background: The HIV-HCV population benefits from a high medical coverage, wide indications to treat HCV and is slowly decreasing over time in European countries. We report the impact of Direct Acting Antiviral agents (DAA) at the population level in French HIV-HCV coinfected patients. Methods: The DatAIDS cohort covers about 25% of HIV-infected patients in care in France. All HIV-HCV coinfected patients followed between 2012 and 2015 were included. HCV status was defined yearly as naive, spontaneous cure, sustained virological response (SVR), failure or reinfection. The incidence of HCV infection and reinfection and HCV treatment initiation rate were determined yearly. Results: Among 32,945 HIV-infected patients, 5001 were HIV-HCV coinfected (prevalence 15.2%). Patients were mostly male (71.9%), IVDU (51.0%), of median age 51 years, infected with HCV genotype 1a (39.5%), 3 (21.0%) or 4 (22.0%), with fibrosis F3-4 in 41.4%. From 2012 to 2015, 146 of 17,890 HCV negative patients with serological follow-up acquired HCV. Incident cases were mostly male (98%), MSM (87%) infected with HCV genotype 1a (39%) or 4 (53%). HCV incidence rate increased from 0.35 per 100 person-years (%PY) to 0.69%PY in MSM, while the median incidence in other patients was 0.08%PY. Reinfections occurred in 45 patients (male 93%, MSM 71%, genotype 1a 47% or 4 38%), including 2 patients with another reinfection. Median reinfection rate was 2.56%PY in MSM and 0.22%PY in other patients. Median death rate was 1.4%PY. HCV treatment initiation rate rose from 8.2% in 2012 to 29.4% in 2015, particularly in pre-treated patients (48.0% in 2015 vs 22.6% in naive patients). Pegylated-interferon (PEG-IFN)/ribavirin (RBV) use declined from 37.9% to 0.3%, while RBV+DAAs rose from 0% to 25.0% and DAAs combinations from 0% to 73.7%. SVR rate increased from 68.7% to 95.2%. By the end of 2015, naive patients, spontaneous cure, treatment failure, and SVR accounted for 29.5%, 12.6%, 7.7% and 50.1% of the patients respectively. Conclusion: HCV treatment dramatically increased in HIV-HCV coinfected patients in France from 2012 to 2015 resulting in HCV cure in more than half of the patients. Combined with a declining HCV prevalence, the prevalence of active HCV infection among HIV patients is expected to drastically decrease in forthcoming years. Since new HCV infections and reinfections mostly occur in MSM, strengthened information and preventive measures are necessary to achieve viral eradication in the HIV-HCV population. 551 SAME SAME BUT DIFFERENT? RISK OF DAA THERAPY FAILURE IN REAL-LIFE HCV/HIV COINFECTION Christoph Boesecke 1 , Patrick Ingiliz 2 , Florian Berger 3 , Thomas Lutz 4 , Knud Schewe 5 , Julian Schulze zur Wiesch 6 , Axel Baumgarten 2 , Stefan Christensen 7 , Jürgen K. Rockstroh 1 , Stefan Mauss 3 1 Univ Hosp Bonn, Bonn, Germany, 2 Cntr for Infectiology, Berlin, Germany, 3 Cntr for HIV and Hepatogastroenterology, Duesseldorf, Germany, 4 Infektiologikum, Frankfurt, Germany, 5 dagnae e.V., Berlin, Germany, 6 Univ Med Cntr, Hamburg–Eppendorf, Hamburg, Germany, 7 CIM Infectious Diseases, Münster, Germany Background: Directly-acting agents (DAA) against HCV have impressively improved treatment of chronic hepatitis C coinfection. However, relapses still occur. Therefore we assessed the influence of traditional risk factors on treatment outcome in HCV/HIV coinfected patients in the German hepatitis C cohort (GECCO). Methods: The GECCO cohort is a multicenter cohort from 9 sites in Germany. All HCV/HIV coinfected patients (361/1791) with complete follow-up having received one of the following DAA regimen were analysed: Pegylated interferon plus ribavirin (RBV) + sofosbuvir (SOF); SOF + RBV; SOF + simeprevir; SOF + daclatasvir +/- RBV; SOF + ledipasvir; paritaprevir/ritonavir, ombitasvir +/- RBV and +/- dasabuvir. Treatment outcome was measured as sustained virologic response 12 weeks after end of therapy (SVR12). Fisher’s exact, chi-square and Mann-Whitney U test were used for statistical analysis. Results: 319/361 (88%) patients were male, median age was 48 years (IQR:42-53). HCV genotype (GT) distribution was: GT1 69%, GT2 3%, GT3 10%, GT4 18%. 65/170 (38%) had IL28B C/C polymorphism. 103/361 (29%) had high baseline HCV RNA (>6 Mio IU/mL). Median baseline ALT was 66U/l (44-109). 172/361 (48%) were treatment-experienced (TE).

Poster and Themed Discussion Abstracts

Liver cirrhosis was present in 71/361 (20%). Median CD4 nadir was 218/ ul (129-374). 62/361 (17%) had baseline CD4 <350/ul, 54/361 (15%) baseline CD4 <20%. 357/361 (99%) were on cART. 78/361 (22%) were on opiate substitution therapy (OST). Overall SVR rate was 94%. In univariate analysis neither sex (p=0.588), age (p=0.439), GT (p=0.615), high HCV RNA (p=0.749), ALT (p=0.901), DAA regimen (p=0.390), TE (p=0.479), CD4 nadir (p=0.473) or OST (p=0.267) were statistically significantly associated with SVR. However, patients with CD4 <350/ul (p=0.038), CD4 <20% (p=0.017) and with liver cirrhosis (p=0.003) were less likely to achieve SVR (see figure 1). In multivariate analysis only liver cirrhosis (p=0.02, OR 3.5 (95%CI 1.2-9.9)) remained statistically significantly associated with Non-SVR. Conclusion: Despite considerably improved efficacy of treatment of chronic hepatitis C with DAAs in HCV/HIV-coinfection liver cirrhosis remains as a risk factor for DAA treatment failure. Low CD4 cells were highly correlated with liver cirrhosis probably due to splenomegaly causing lymphopenia. This highlights the need for early initiation of DAA therapy in HCV/HIV coinfection before the onset of higher liver fibrosis/ cirrhosis to allow for optimal rates of viral eradication.

CROI 2017 231