Lenacapavir Demonstrates Safety and Efficacy Through a Year


The twice-yearly injectable shown to be beneficial in conjunction with an optimized background regimen.

People with multi-drug resistant (MDR) HIV have limited therapy options, which can leave their disease management very challenging. And there are only a couple of treatment options for these patients.

Last winter the FDA approved lenacapavir for the indication of treating adult patients living with HIV, whose infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations.

“Today’s approval ushers in a new class of antiretroviral drugs that may help patients with HIV who have run out of treatment options,” Debra Birnkrant, MD, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said in a statement at that time.

At the ongoing International AIDS Society (IAS) Conference 2023, Gilead Sciences is presenting new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including patient-reported outcomes (PRO) from the phase 2/3 CAPELLA trial.

Using 5 validated scoring instruments measuring health-related quality of life components including physical and mental health, CAPELLA participants (n=64/72) reported favorable scores at Week 52 and with relative consistency over the time period. These reflect values that are similar to that of the general US population. Separate analyses from the phase 2/3 CAPELLA and Phase 2 CALIBRATE trials showed weekly oral lenacapavir, when paired with optimized background regimen, led to high rates of virologic suppression and high, efficacious concentrations of lenacapavir in the blood in study participants when the administration of subcutaneous lenacapavir was interrupted.

“Understanding potential real-world use of novel HIV options is essential to helping ensure they have the greatest potential impact,” Jared Baeten, MD, PhD, vice president, HIV Clinical Development, Gilead, said in a statement. “The patient-reported outcome data presented at IAS 2023 provide deep insight into the tolerability of lenacapavir, and the oral bridging data helps demonstrate how twice-yearly lenacapavir can fit into people’s lives. As we continue development of lenacapavir-based options with the goal to optimize HIV treatment, people’s experience and insights are at the center.”

These latest findings underscore the role of lenacapavir, the first long-acting injectable HIV treatment medication administered twice-yearly, as a person-centric therapy option and its transformative potential impact on the future of coordinated HIV clinical care.

Patient-reported outcomes through Week 52 from the CAPELLA study were gathered from five validated instruments that assess quality of life: the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) index, EQ-5D-5L visual analogue scale (VAS), Short Form-36 (SF-36), HIV Symptom Index (HIV-SI), and Numeric Pain Rating Scale (NPRS). Of the 72 enrolled participants, 64 reported outcomes through Week 52, with notable stability in scores at baseline through Week 52 and generally reflective of the US population norms. These data demonstrate lenacapavir plus an optimized background regimen has the potential to be an effective HIV regimen without compromising health-related quality of life.

The company said it is studying lenacapavir as a long-acting option in multiple ongoing and planned early and late-stage clinical studies for HIV prevention and treatment.

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