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HIGH HBV AND HIV SUPPRESSION WITH TREATMENT OF HIV/HBV COINFECTION IN B/F/TAF STUDIES
Jürgen K. Rockstroh1, Paul E. Sax2, Eric Daar3, Sharon Walmsley4, Kimberly Workowski5, Chloe Orkin6, Jose R. Arribas7, Edwin DeJesus8, David Wohl9, Jean-Michel Molina10, David Piontkowsky11, Xuelian Wei11, Hal Martin11, Andrew Cheng11, Erin Quirk11
1Bonn University Hospital, Bonn, Germany,2Brigham and Women's Hospital, Boston, MA, USA,3Harbor–UCLA Medical Center, Torrance, CA, USA,4Toronto General Hospital, Toronto, ON, Canada,5Emory University, Atlanta, GA, USA,6Royal London Hospital, London, UK,7La Paz University Hospital, Madrid, Spain,8Orlando Immunology Center, Orlando, FL, USA,9University of North Carolina Chapel Hill, Chapel Hill, NC, USA,10Hôpital Saint-Louis, Paris, France,11Gilead Sciences, Inc, Foster City, CA, USA
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).
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.
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.
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.