Real word outcomes associated with use of raltegravir in older people living with HIV: results from the 60 months follow-up of the RAL-age cohort

ABSTRACT

Objective: In people living with HIV (PLWH), antiretroviral treatments have increased the median life expectancy. Raltegravir (RAL) represents a long-term safe regimen used both in the first-line antiretroviral treatments and in the optimization strategies. Aim of the study was to evaluate the real-life efficacy, tolerability, and safety of the long-term RAL use in a multicenter cohort of elderly PLWH.

Methods: A 60-month follow-up observational study was carried out in the RAL-AGE Cohort including aged PLWH (≥60 years old) treated with RAL-based regimens (n = 96). The control group was a cohort of PLWH aged less than 60 years (n = 50).

Results: RAL treated aged HIV population experiences an increase of CD4⁺ cells and a stable control of viral load at 60 months of follow-up. A significant improvement in lipid metabolism profile, a decrease of platelet count and a reduction in cardiovascular risk levels were observed in the older population. Immune activation markers expressed on CD4⁺ T cells decreased compared to baseline, but this difference was greater in the control group.

Conclusion: A 60-month treatment with RAL-containing regimens is safe and highly effective in the older PLWH and these data give new insights on the elderly population.

Clinical trial registration: NCT02765776 and NCT03579485

KEYWORDS:

• Efficacy
• immune activation
• metabolism
• raltegravir
• real-life
• tolerability

Article highlights

• RAL treatment remains effective after 5 years of follow up in older PLWH.

• Long-term real-life experience showed a safe profile of RAL-based regimens in older PLWH.

• RAL is associated to an improvement in lipid metabolic profile.

• RAL-containing regimen reduces immune activation levels in older PLWH.

• Further, larger studies should be performed to confirm these data and analyze if the reduction of immunoactivation and improvement of lipid metabolism could also impact on the cardiovascular risk.

Author Contributions

Study conceptualization and design, LS, GC, GdE; Data Curation, CB, LC, PP, GPI, OS, CF, FC, FDS; Data analysis and interpretation, CB, LC, PP, GPI; Critical revision for intellectual content, IM, CMM, GdE; Final approval of published version, LS, GC, GdE; all authors agree to be accountable for all aspects of the work.

Declaration of Interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

Supported in part by a research grant awarded under the Investigator Initiated Study Program of Merck Sharp & Dohme [MSD] Corp. The views expressed in this report are from the authors and do not necessarily represent those of Merck Sharp & Dohme Corp.