CROI 2018 Abstract eBook

Abstract eBook

Poster Abstracts

617 HIGHER RATES OF HBSAG CLEARANCE WITH TDF-CONTAINING THERAPY IN HBV/HIV COINFECTION Pierre Gantner 1 , Laurent Cotte 2 , Clotilde Allavena 3 , Firouze Bani-Sadr 4 , Thomas Huleux 5 , Claudine Duvivier 6 , Marc-Antoine Valantin 7 , Christine Jacomet 8 , Veronique Joly 9 , Antoine Chéret 10 , Pascal Puglièse 11 , Pierre Delobel 12 , André Cabié 13 , David Rey 1 1 Hôpitaux Universitaires de Strasbourg, Strasbourg, France, 2 Hospices Civils de Lyon, Lyon, France, 3 CHU de Nantes, Nantes, France, 4 CHU de Reims, Reims, France, 5 Centre Hospitalier de Tourcoing, Tourcoing, France, 6 Necker Hospital, Paris, France, 7 Pitié-Salpêtrière Hospital, Paris, France, 8 CHU de Clermont-Ferrand, Clermont- Ferrand, France, 9 Bichat–Claude Bernard Hospital, Paris, France, 10 Hôpital Bicêtre, Le Kremlin-Bicetre, France, 11 Nice University Hospital, Nice, France, 12 Toulouse University Hospital, Toulouse, France, 13 CHU Fort de France, Fort de France, Martinique Background: HIV-infected individuals are at high risk of developing chronic hepatitis B (HBV) after acute infection, while functional cure of this chronic infection (Hepatitis B surface antigen [HBsAg] clearance, eventually followed by acquisition of anti-hepatitis B surface antigen [Anti-HBs]) is a rare event. Related factors to HBV cure in this setting are not fully characterized, and there are no data on quantitative HBsAg follow-up. Methods: HIV-infected individuals with chronic HBV infection starting combined antiretroviral-anti-HBV treatment were retrospectively included from the French National Dat’AIDS cohort (NCT02898987). HCV co-infected subjects were excluded. Primary outcomes were confirmed HBsAg loss and Anti-HBs seroconversion. Bayesian analysis was used to study the risk factors for HBsAg clearance. Results: A total of 1419 subjects were allocated to three HBV therapy schedule: 3TC/FTC only (group 1, n=150), TDF with or without 3TC/FTC (group 2, n=489) and 3TC/FTC as first line followed by adding/switching to TDF as second line (group 3, n=780). Subjects were primarily male (76%), had a median age of 36 years at baseline, and 6% of themwere co-infected with hepatitis D virus. Patients were followed-up for a median of 89 months (IQR, 56-118). Median HBV-DNA decreased from 3.64 to 2.06 log IU/mL, from baseline to the end of follow-up, respectively. Overall, 97 individuals cleared HBsAg (0.7/100 patient- years), of whom, 67 seroconverted for Anti-HBs (0.5/100 patient-years). HBsAg clearance occurred in 25, 19 and 53 individuals in group 1, 2 and 3 at a median time of 73, 45 and 137 months, respectively. A high CD4 nadir, a short delay between HBV diagnosis and treatment, a longer time on HBV therapy, an African origin and TDF-based therapy were independent predictors of HBsAg clearance (Probability of odds ratio [OR]>1, >95%). Bayesian analysis suggested a 99% probability that TDF-based regimen as first line (OR, 3.03) or second line (OR, 2.95) increased rates of HBsAg clearance at 72 months when compared to 3TC/ FTC alone as first line (Figure). Longitudinal follow-up of quantitative HBsAg on treatment showed a slow but significant decrease in HBsAg serum levels (-1 IU/ mL per year). Conclusion: HBsAg clearance rates were low while on HBV therapy; higher CD4 nadir, prompt initiation of HBV therapy, mainly with TDF-based regimen, improved HBsAg clearance and Anti-HBs seroconversion. Quantitative HBsAg significantly decreased, therefore could be a prognostic factor of HBV clearance.

618 HIGH HBV AND HIV SUPPRESSION WITH TREATMENT OF HIV/HBV COINFECTION IN B/F/TAF STUDIES Jürgen K. Rockstroh 1 , Paul E. Sax 2 , Eric Daar 3 , Sharon Walmsley 4 , Kimberly Workowski 5 , Chloe Orkin 6 , Jose R. Arribas 7 , Edwin DeJesus 8 , David Wohl 9 , Jean-Michel Molina 10 , David Piontkowsky 11 , Xuelian Wei 11 , Hal Martin 11 , Andrew Cheng 11 , Erin Quirk 11 1 Bonn University Hospital, Bonn, Germany, 2 Brigham and Women’s Hospital, Boston, MA, USA, 3 Harbor–UCLA Medical Center, Torrance, CA, USA, 4 Toronto General Hospital, Toronto, ON, Canada, 5 Emory University, Atlanta, GA, USA, 6 Royal London Hospital, London, UK, 7 La Paz University Hospital, Madrid, Spain, 8 Orlando Immunology Center, Orlando, FL, USA, 9 University of North Carolina Chapel Hill, Chapel Hill, NC, USA, 10 Hôpital Saint-Louis, Paris, France, 11 Gilead Sciences, Inc, Foster City, CA, USA Background: HBV is a common coinfection in HIV patients. We report HBV and HIV outcomes in ART-naïve and experienced HIV/HBV-coinfected subjects enrolled in 4 studies of bictegravir/emtricitabine/tenofovir alafenamide (B/F/ TAF). Methods: HBV serologies were collected at baseline (BL) and week (W) 48 in 4 B/F/TAF studies: Studies 1489 (B/F/TAF vs abacavir/lamivudine/ dolutegravir [DTG, ABC/3TC/DTG] as initial therapy), 1490 (B/F/TAF vs F/TAF+DTG as initial therapy), 1878 (switch from PI + 2 NRTIs to B/F/TAF vs stay on BL regimen [SBR]), and 1844 (maintain ABC/3TC/DTG vs switch to B/F/TAF). Studies 1490 and 1878 permitted HBV-infected patients to enroll; HBV coinfection was excluded from Studies 1489 and 1844 due to ABC/3TC in control arms. HBV seropositive patients had HBV DNA at baseline and W48. Proportion with W48 HBV DNA <29 IU/mL using missing=excluded data imputation was pre-specified for studies 1490 and 1878. HBV serology and DNA results were analyzed to identify incident HBV infections in all 4 studies through W48. Results: In Study 1490, 14 naïve coinfected subjects (n=12 HBV surface antigen [HBsAg] positive and n=2 HBsAg-/core antibody+ and HBV DNA detectable) were randomized to B/F/TAF (n=8) or DTG+F/TAF (n=6). 1 HBsAg positive subject (DTG+F/TAF group) discontinued study at Day 68. At W48, 11/13 (85%) had HBV DNA <29 IU/mL. 2/11 had HBsAg loss. In Study 1878, 14 treatment experienced coinfected subjects were randomized to stay on BL regimen (SBR, n=6) or switch to B/F/TAF (n=8). 2/14 had HBV DNA >29 IU/mL at BL: 1 (SBR) who discontinued at Day 1 and had no post BL HBV DNA, and 1 (B/F/ TAF) who at W48 had HBV DNA ≥29 IU/mL. 12/12 with suppressed HBV DNA at BL maintained HBV DNA <29 IU/mL at W48; none had HBsAg conversion. W48 HIV-1 RNA was <50 copies/mL in 25/28 of those with HIV/HBV coinfection at BL in these two studies (89%). In these two trials plus Studies 1489 and 1844, no patient receiving B/F/TAF, F/TAF or F/TDF acquired HBV. One naïve subject randomized to ABC/3TC/DTG acquired HBV infection by W48. Conclusion: High rates of HBV suppression were achieved at W48 in naïve HIV/HBV coinfected patients treated with F/TAF regimens. HBV suppression was maintained in experienced patients switching to B/F/TAF. At W48, HIV suppression among HBV coinfected patients was high and comparable to those with HIV mono-infection. Further studies of B/F/TAF and other regimens containing F/TAF for HBV treatment and prevention in HIV-infected patients are warranted.

Poster Abstracts

CROI 2018 228