CROI 2024 Abstract eBook

Abstract eBook

Poster Abstracts

642

Phase II Study of Switch to Daily BIC + LEN in Individuals on a Multitablet HIV Treatment Regimen Karam Mounzer 1 , Jihad Slim 2 , Moti Ramgopal 3 , Malcolm Hedgcock 4 , Mark Bloch 5 , Jorge Santana 6 , Ines Mendes 7 , Ying Guo 7 , Priyanka Arora 7 , Jairo M. Montezuma-Rusca 7 , Hal Martin 7 , Peter Sklar 7 , Jared Baeten 7 , Sorana Segal Maurer 8 1 Philadelphia FIGHT, Philadelphia, PA, USA, 2 New York Medical College, Valhalla, NY, USA, 3 Midway Immunology and Research Center, Fort Pierce, FL, USA, 4 Spectrum Health, Vancouver, Canada, 5 Holdsworth House Medical Practice, Darlinghurst, Australia, 6 University of Puerto Rico, San Juan, Puerto Rico, 7 Gilead Sciences, Inc, Foster City, CA, USA, 8 New York Presbyterian Hospital Queens, New York, NY, USA Background: While single-tablet regimens (STRs) are currently the global standard for HIV treatment, some people with HIV (PWH) take multi-tablet regimens (MTR) due to treatment resistance, intolerance or drug interactions. The combination of bictegravir (BIC), an integrase strand transfer inhibitor, and lenacapavir (LEN), a first-in-class capsid inhibitor, could simplify treatment in virologically suppressed (VS) PWH for whom STRs are not indicated. We report the Phase 2, 24-Week primary outcomes for BIC + LEN versus stable baseline regimen (SBR) in VS PWH on a complex regimen. Methods: ARTISTRY-1 (NCT05502341) is an ongoing, randomized, open-label, multicenter Phase 2/3 study. In Phase 2, 128 participants on SBR (≥6 months prior to screening) were randomized 2:2:1 to receive once-daily oral BIC 75 mg + LEN 25 mg, oral BIC 75 mg + LEN 50 mg or continue SBR. All participants receiving BIC + LEN received an oral loading dose of LEN 600 mg on Days 1 and 2 of treatment. The primary endpoint was the proportion of participants with HIV RNA ≥50 copies/mL (FDA Snapshot) at Week 24. Secondary endpoints included the proportion of participants with HIV RNA <50 copies/mL, change from baseline in CD4 cell count and the proportion of participants with treatment emergent adverse events (TEAEs) up to Week 24. Results: 51 and 52 participants received BIC 75 mg + LEN 25 mg or BIC 75 mg + LEN 50 mg, respectively, and 25 continued SBR. At baseline, 19% of participants were female, 31% were Black and 16% were Hispanic or Latinx; median (Q1, Q3) age was 60 (56, 65) years and participants were taking a median (range) of 3 (2–9) tablets per day. Outcomes at Week 24 are shown in the Table. HIV-1 RNA was ≥50 copies/mL in 0/51 of participants in the BIC 75 mg + LEN 25 mg group, 1/52 (2%) in the BIC 75 mg + LEN 50 mg group (later suppressed to <50 copies/mL without regimen change) and 0/25 in the SBR group. CD4 counts were comparable in all groups. The most common TEAEs in the two BIC + LEN treatment groups up to Week 24 were diarrhea (7%), COVID-19 (6%) and constipation (5%). Drug-related TEAEs occurred in 18%, 6% and 0% of participants, respectively. Conclusion: BIC + LEN was highly effective in maintaining viral suppression in participants switching from an MTR, with similar safety profiles observed in the two BIC + LEN treatment groups. These data support the use of BIC and LEN in combination to simplify treatment in VS PWH who are receiving complex regimens. A BIC/LEN STR will be tested in the Phase 3 part of the study.

641

Switching From a Second-Line Boosted PI Regimen to B/F/TAF: Results of a Randomized Clinical Trial Samuel Pierre 1 , Jean Bernard Marc 1 , Fabienne Homeus 1 , Guirlaine Rivette Bernadin 1 , Letizia Trevisi 2 , Evens Jean 1 , Emelyne Dumont 1 , Sanjana Sundaresan 3 , Vanessa Rivera 1 , Dennis Israelski 4 , Sean E. Collins 4 , Jean W. Pape 1 , Patrice Severe 1 , Paul E. Sax 5 , Serena Koenig 2 1 GHESKIO, Port-au-Prince, Haiti, 2 Harvard Medical School, Boston, MA, USA, 3 Analysis Group, Inc, Boston, MA, USA, 4 Gilead Sciences, Inc, Foster City, CA, USA, 5 Brigham and Women's Hospital, Boston, MA, USA Background: Patients on second-line boosted PI-based regimens in resource limited settings have high rates of NRTI resistance, but this information is unknown in routine clinical care. This study compared continuing boosted PI + NRTIs vs bictegravir/tenofovir alafenamide/emtricitabine (B/F/TAF) in PWH on second-line ART with no prior drug resistance testing. Methods: This prospective, open-label trial conducted at GHESKIO in Port au-Prince, Haiti, randomized adults (≥18 years) with viral suppression on second-line PI/r-based ART to continue their current regimen vs. switch to B/F/ TAF. The primary endpoint was the proportion of participants with HIV-1 RNA ≥200 copies/mL at week 48 using the FDA snapshot algorithm, the difference between groups was assessed with a non-inferiority margin of 4%. Results: Between October 2020 and March 2023, 290 participants were randomized and treated (B/F/TAF: 149; bPI: 141). Median age was 50 years (IQR 42, 58) and 165 (57%) were women. At enrollment, 175 (60%) were taking lopinavir/r and 115 (40%) atazanavir/r; 226 (78%) were taking tenofovir disoproxil fumarate, 51 (18%) zidovudine, and 13 (4%) abacavir; all were taking lamivudine or emtricitabine. The median time on PI/r was 3.7 years (IQR 2.2, 5.7) years. At week 48, the proportion with HIV-1 RNA ≥200 copies/mL was 0.7% (1/149) and 2.8% (4/141) in the B/F/TAF and PI/r groups, respectively: difference -2.1 (95% CI: -6.7 to 1.2), meeting non-inferiority for B/F/TAF compared to PI/r (Table 1). 140 (94.0%) and 129 (91.5%), respectively had 48-week HIV-1 RNA <200 copies/mL. Eight in each group were censored – all had HIV-1 RNA <200 copies/mL at latest test (B/F/TAF: 4 completed study with no 48-week viral load; 1 died; 3 lost or left country; PI/r: 2 completed study with no 48-week viral load; 1 stopped study due to pregnancy; 2 died; 3 were lost or left country). There were no study drug discontinuations due to adverse events in either group. Baseline archived proviral DNA (B/F/TAF group) and genotypic resistance testing for virologic failures (both groups) are pending. This study was conducted during both COVID-19 and severe civil unrest and gang-related violence in Haiti. Follow-up was enabled by community health workers and neighborhood drug distribution when travel in Port-au-Prince was not safe or not possible for participants. Conclusion: Switching virally suppressed adults on a second-line PI/r regimen to B/F/TAF is non-inferior to continuing PI/r-based ART. Rates of viral suppression were high in both groups.

Poster Abstracts

643

A Randomized Trial Switching Adults ≥ 60 Years Old From First-Line ART to B/F/TAF: Week 48 Results Loice A Ombajo 1 , Jeremy Penner 2 , Joseph Nkuranga 1 , Edwin Otieno 1 , Victor Mbewa 1 , Jared O. Mecha 1 , Simon Wahome 3 , Florentius Ndinya 4 , Sanjay Bhagani 5 , Anton L. Pozniak 6 , for the B/F/TAF Study Group 1 University of Nairobi, Nairobi, Kenya, 2 University of British Columbia, Vancouver, Canada, 3 Kenyatta National Hospital, Nairobi, Kenya, 4 Jaramogi Oginga Odinga Teaching & Referral Hospital, Kisumu, Kenya, 5 Royal Free Hospital, London, United Kingdom, 6 London School of Hygiene and Tropical Medicine, London, United Kingdom Background: Age-related comorbidities and toxicities of some antiretrovirals (ART) limit treatment options for the aging population of people living with HIV.

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