Treatment outcomes in people with a late HIV diagnosis: a pooled analysis of participants with advanced HIV disease at diagnosis randomized to receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)
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Authors
Rockstroh J.
Avihingsanon A.
Orkin C.
Lazzarin A.
Workowski K.
Liu H.
Hindman J.T.
Sax, P.
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2025
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Article
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Purpose: Late HIV diagnoses are associated with increased morbidity and mortality. This post hoc analysis investigated B/F/TAF in treatment-naive people with advanced HIV disease (AHD) at diagnosis. Method(s): Data were pooled from participants randomized to B/F/TAF in three clinical trials, including extension phases (Studies 1490, 1489 [both 240 weeks], and ALLIANCE [144 weeks]). AHD was defined as an AIDS diagnosis and/or baseline CD4 count <200 cells/muL. Coprimary endpoints were virologic suppression (VS; HIV-1 RNA <50 copies/mL; missing=excluded [M=E] analysis) and CD4 cell count at Week 0, 4, 8, and 12, and every 12 weeks thereafter up to Week 240. Secondary endpoints included treatment-emergent adverse events (TEAEs) up to Week 240 and baseline factors associated with AHD at diagnosis (univariate analysis). Result(s): Overall, 755 participants were included. Baseline characteristics are shown in the Table. All participants had HIV-1 RNA >=50 copies/mL at baseline. Participants without AHD reached high VS levels (>=96%; M=E analysis) by Week 12; participants with AHD reached this threshold by Week 48 (Figure 1). Thereafter, VS remained high through Week 144 and up to Week 240. Missing=failure analysis yielded similar results. Increased CD4 cell counts were observed in participants with and without AHD up to Week 240 but remained significantly lower in those with AHD (- Figure 2). There was a strong association between lower baseline body mass index (<sup>2</sup>) and AHD (P<0.0001). The incidences of TEAEs, serious TEAEs, drug-related TEAEs, discontinuations due to TEAEs, and deaths up to Week 240 were similar for participants with and without AHD. Conclusion(s): Participants with AHD at diagnosis achieved high VS rates up to Week 240, with no safety concerns. Consistent with previous studies, people with AHD took longer to achieve VS and maintained lower CD4 cell counts than those without AHD. Early diagnosis is, therefore, key to achieving positive treatment outcomes.
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HIV.Med.