Abstract

Long-acting (LA) formulations have been designed to improve the quality of life of people with HIV (PWH) by maintaining virologic suppression. However, clinical trials have shown that patient selection is crucial. In fact, the HIV-1 resistance genotype test and the Body Mass Index of individual patients assume a predominant role in guiding the choice. Our work aimed to estimate the patients eligible for the new LA therapy with cabotegravir (CAB) + rilpivirine (RPV). We selected, from the Antiviral Response Cohort Analysis (ARCA) database, all PWH who had at least one follow-up in the last 24 months. We excluded patients with HBsAg positivity, evidence of non-nucleoside reverse transcriptase inhibitor (except K103N) and integrase inhibitor mutations, and with a detectable HIV-RNA (>50 copies/mL). Overall, 4103 patients are currently on follow-up in the ARCA, but the eligible patients totaled 1641 (39.9%). Among them, 1163 (70.9%) were males and 1399 were Caucasian (85.3%), of which 1291 (92%) were Italian born. The median length of HIV infection was 10.2 years (IQR 6.3–16.3) with a median nadir of CD4 cells/count of 238 (106–366) cells/mm3 and a median last available CD4 cells/count of 706 (509–944) cells/mm3. The majority of PWH were treated with a three-drug regimen (n = 1116, 68%). Among the 525 (30.3%) patients treated with two-drug regimens, 325 (18.1%) were treated with lamivudine (3TC) and dolutegravir (DTG) and only 84 (5.1%) with RPV and DTG. In conclusion, according to our snapshot, roughly 39.9% of virologically suppressed patients may be suitable candidates for long-acting CAB+RPV therapy. Therefore, based on our findings, many different variables should be taken into consideration to tailor the antiretroviral treatment according to different individual characteristics.

Highlights

  • HIV infection has become a chronic condition with a life expectancy comparable to uninfected people [1]

  • This is due to the introduction of modern antiretroviral therapy (ART) and its extensive use in both naïve and experienced patients, which leads to viral suppression in a high percentage of people with HIV (PWH) [2]

  • Several downsides have emerged or remain critical: (i) the therapy is lifelong; (ii) the oral route is the only path of administration, leading to issues for patients with dysphagia or altered consciousness; (iii) all available compounds need to be taken daily, which requires high compliance by the patient; (iv) the aging of the HIV-population leads to age-related pathologies [9,10,11]; (v) polypharmacotherapy must account for the risk of incorrect drug assumption and interaction [12]; (vi) there are still patients with limited treatment options due to viral resistance for those in whom preserving available molecules remains critical [13,14]; and (vii) the current SARS-CoV-2 pandemic has led to a more complex and discontinued retention in care and treatment adherence [15]

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Summary

Introduction

HIV infection has become a chronic condition with a life expectancy comparable to uninfected people [1]. This is due to the introduction of modern antiretroviral therapy (ART) and its extensive use in both naïve and experienced patients, which leads to viral suppression in a high percentage of people with HIV (PWH) [2]. (ii) the oral route is the only path of administration, leading to issues for patients with dysphagia or altered consciousness; (iii) all available compounds need to be taken daily, which requires high compliance by the patient; (iv) the aging of the HIV-population leads to age-related pathologies (e.g., dementia) [9,10,11]; (v) polypharmacotherapy must account for the risk of incorrect drug assumption and interaction [12]; (vi) there are still patients with limited treatment options due to viral resistance for those in whom preserving available molecules remains critical [13,14]; and (vii) the current SARS-CoV-2 pandemic has led to a more complex and discontinued retention in care and treatment adherence [15].

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