RESUMO
Background/Aims: The clinical course of hepatitis B virus (HBV) infection in individuals with HIV-1 coinfection is marked by accelerated disease progression. A tenofovir-containing antiretroviral regimen is recommended in most people with HIV-1/HBV-coinfection, but there have not been randomized studies of tenofovir disoproxil fumarate (TDF) vs tenofovir alafenamide (TAF) in treatment- naive HIV-1/HBV-coinfected individuals. We report primary endpoint results from a Phase 3 study comparing bictegravir/emtricitabine/ TAF (B/F/TAF) vs dolutegravir + emtricitabine/TDF (DTG + F/TDF) at Week (W)48 in participants initiating treatment for both viruses. Method(s): Adults with HIV-1/HBV coinfection were randomized 1:1 to initiate blinded treatment with B/F/TAF or DTG + F/TDF (with placebo). Primary endpoints were the proportion of participants with HIV-1 RNA<50 copies/mL (FDA Snapshot) and plasma HBV DNA<29 IU/mL (missing = failure) at W48. Noninferiority was assessed with 95% CI (12% margin). Secondary and other endpoints included change from baseline cluster of differentiation 4 (CD4) count, proportion with hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) loss/seroconversion, and alanine transaminase (ALT) normalization (AASLD criteria). Result(s): Participants (N = 243) were randomized and treated (B/F/ TAF [n = 121], DTG + F/TDF [n = 122]) from 11 countries in Asia, Europe, North, and Latin America. Baseline characteristics were median age of 32 years, 4.5% female, 88% Asian, 30% HIV-1 RNA>100,000 c/mL, 40% CD4<200 cells/lL, median HBV DNA 8.1 log10 IU/mL, 78% HBeAg+. At W48, B/F/TAF was noninferior to DTG + F/TDF at achieving HIV-1 RNA<50 copies/mL (95% vs 91%, difference 4.1%;95% CI -2.5%-10.8%;P = 0.21), with mean CD4 gains of + 200 and + 175 cells/lL, respectively. B/F/TAF was superior to DTG + F/TDF at achieving HBV DNA<29 IU/mL (63% vs 43%, difference 16.6%;95% CI 5.9%-27.3%;P = 0.0023). Participants treated with B/F/TAF vs DTG + F/TDF had numerically higher HBsAg loss (13% vs 6%;P = 0.059), HBeAg loss (26% vs 14%;P = 0.055), HBeAg seroconversion (23% vs 11%;P = 0.031), and ALT normalization (73% vs 55%;P = 0.066). The most frequent adverse events among participants treated with B/F/TAF vs DTG + F/TDF were upper respiratory tract infection (17% vs 11%), COVID- 19 (13% vs 11%), pyrexia (9% vs 12%), ALT increase (7% vs 11%), and nasopharyngitis (11% vs 4%). ALT flares (elevations at >= 2 consecutive postbaseline visits) occurred in 11 participants (7 B/F/ TAF, 4 DTG + F/TDF), and all resolved. Conclusion(s): Among adults with HIV-1/HBV-coinfection starting antiviral therapy, both B/F/TAF and DTG + F/TDF had high HIV-1 suppression at year 1, with B/F/TAF resulting in superior HBV DNA suppression and significantly more HBeAg seroconversion. Safety findings were similar between groups.
RESUMO
Proceedings of: 25th Bangkok International Symposium on HIV Medicine, 18-20 January 2023, held virtually and on site at Samyan Mitrtown Hall, Bangkok, Thailand. The Bangkok International Symposium on HIV Medicine has commenced on the third Wednesday of January since 1998. The Symposium aims to provide professional healthcare workers in Thailand and the region an opportunity to receive the most up-to-date information on HIV and its related conditions if they are unable to attend other HIV conferences abroad. This year's hybrid symposium was held from 18 January to 20 January 2023. A total of six plenary sessions were held in the mornings, and four afternoon workshops held on Wednesday and Thursday. Expert speakers from Thailand, China, Malaysia, Singapore, India, Hong Kong, the Philippines, Australia, the UK, The Netherlands and the USA participated in the symposium.Copyright © 2023 Future Medicine Ltd.
RESUMO
The Bangkok International Symposium on HIV Medicine has commenced on the 3rd Wednesday in January since 1998. The Symposium aims to provide professional healthcare workers in Thailand and the region an opportunity to receive the most up-to-date information on HIV and its related conditions if they are unable to attend other HIV conferences abroad. This year's hybrid symposium was held from 18 January to 20 January 2023. A total of six plenary sessions were held in the mornings, and four afternoon workshops held on Wednesday and Thursday. Expert speakers from Thailand, China, Malaysia, Singapore, India, Hong Kong, Philippines, Australia, UK, The Netherlands and the USA participated in the symposium.
RESUMO
HIV-NAT has held the Bangkok International Symposium on HIV Medicine annually since 1998. It provides the latest advances in HIV medicine to professional healthcare workers in the Asia-Pacific region. This year's symposium (the 24th) was held virtually, from 19 to 21 January 2022. There were a total of 27 sessions divided over 3 days. The Symposium started in the afternoon following industrial symposia and ended at 18:00. Various topics were presented by experts from Australia, India, Malaysia, The Netherlands, Singapore, Switzerland, Thailand, UK and USA. COVID-19 has changed healthcare delivery and artificial intelligence is changing medical practice so sessions on these topics were included in the symposium.
RESUMO
Background: To achieve global hepatitis C virus (HCV) elimination by 2030, 80% of the ∼71 million people with chronic HCV need to be treated, necessitating simplification of treatment delivery and associated laboratory monitoring without compromising efficacy or safety. The COVID-19 pandemic has further highlighted the need for innovative models that minimize face-toface contact. Methods: ACTG A5360 is a single-arm, open-label trial to evaluate safety and efficacy of a minimal monitoring (MINMON) approach to HCV therapy in treatment-naïve persons with no evidence of decompensated cirrhosis. All participants received a single-tablet, fixed-dose regimen of sofosbuvir/velpatasvir for 12 weeks. MINMON included: (1) no genotyping;(2) all tablets dispensed at entry;(3) no on-treatment visits/labs;and (4) two remote contacts at Weeks 4 (adherence assessment) and 22 (scheduling sustained virology response [SVR] visit). Unplanned visits for participant concerns (related/unrelated to an adverse event [AE]) were allowed. SVR is defined as HCV RNA <lower limit of quantification at least 22 weeks after treatment initiation (missing HCV RNA = failure). 95% confidence intervals (CI) for SVR used Wilson's Score. Results: 400 participants were enrolled from 10/2018-07/2019 at 38 sites in five countries across 4 continents;399 initiated treatment. Median age was 47 years, 138 (35%) were cisgender women, 22 (6%) self-identified across the transgender spectrum, and 166 (42%) were White. At entry, 34 (9%) had compensated cirrhosis (FIB-4 ≥3.25) and 166 (42%) had HIV co-infection. Remote contact was successful at Weeks 4 and 22 for 394 (99%) and 335 (84%) participants, respectively. HCV RNA for SVR was available for 396 participants. Overall, 95% (379/399) achieved SVR (95% CI: 92.4%, 96.7%);SVR by country, biological sex, gender identity, age, cirrhosis status, HIV co-infection status and injection drug use are presented in Figure. Fifteen (3.8%) participants had unplanned visits;3 were AE related and 6 were related to abnormalities during screening. Serious AE events through Week 24 visit were reported in 14 (3.5%) participants;none were treatment related or resulted in death. Conclusion: In a diverse, global patient population, the MINMON approach to HCV treatment delivery was safe and achieved SVR comparable to current standards. Wider adoption of this approach coupled with innovative casefinding strategies may facilitate HCV elimination while minimizing in-person appointments and resource use.