Efficacy and Safety of Bictegravir Plus Lenacapavir: 48-Week Outcomes in People With HIV-1 Who Are Virologically Suppressed on Complex Antiretroviral Regimens at Baseline

Q: What type of study is this?

This is a Phase 2 study (also classified as: Phase 3).

Karam Mounzer; Jihad Slim; Moti Ramgopal; Malcolm Hedgcock; Mark Bloch; Jorge Santana‐Bagur; Keith Aizen; Xu Zhang; Peter Sklar; Jairo M. Montezuma-Rusca; Sorana Segal‐Maurer

doi:10.1093/ofid/ofaf615

October 6, 2025Open Forum Infectious DiseasesOpen Access

Efficacy and Safety of Bictegravir Plus Lenacapavir: 48-Week Outcomes in People With HIV-1 Who Are Virologically Suppressed on Complex Antiretroviral Regimens at Baseline

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Key Points

Bictegravir plus lenacapavir maintained virologic suppression in HIV-1 patients at 48 weeks, showing effective treatment.
The trial involved 128 vis-ssupressed people, demonstrating that both doses of lenacapavir were well tolerated.
Conducted as a phase 2/3 trial, the findings suggest this combination is a viable alternative to complex regimens.
The results indicate that bictegravir plus lenacapavir may offer a new pathway for maintaining HIV-1 control among patients.

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Implication

Phase 2/3 trial shows bictegravir and lenacapavir maintain virologic suppression in HIV-1, highlighting safety and effectiveness.

Abstract

ARTISTRY-1 is a phase 2/3 trial of bictegravir (BIC; 75mg) plus lenacapavir (LEN; 25mg or 50mg) versus complex antiretroviral therapy regimens in 128 virologically suppressed people with HIV-1. At 48 weeks, BIC+LEN (at either LEN dose) was highly effective at maintaining virologic suppression and was well tolerated.

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Cite This Study

Mounzer et al. (2025) studied this question.

synapsesocial.com/papers/68e5c1b46950a706b22b51af https://doi.org/10.1093/ofid/ofaf615

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Efficacy and Safety of Bictegravir Plus Lenacapavir: 48-Week Outcomes in People With HIV-1 Who Are Virologically Suppressed on Complex Antiretroviral Regimens at Baseline

Key Points

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Implication

Abstract

Discussion

Cite This Study

Efficacy and Safety of Bictegravir Plus Lenacapavir: 48-Week Outcomes in People With HIV-1 Who Are Virologically Suppressed on Complex Antiretroviral Regimens at Baseline

Key Points

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Implication

Abstract

Discussion

Cite This Study

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