Prevalence and Outcomes for Heavily Treatment-Experienced Individuals Living With Human Immunodeficiency Virus in a European Cohort

Pelchen–Matthews, Annegret; Borges, Álvaro H.; Reekie, Joanne; Rasmussen, Line Dahlerup; Wiese, Lothar; Weber, Jonathan; Pradier, Christian; Degen, Olaf; Paredes, Roger; Tau, Luba; Flamholc, Leo; Gottfreðsson, Magnús; Kowalska, Justyna D.; Jabłonowska, Elżbieta; Mozer‐Lisewska, Iwona; Rădoi, Roxana; Vasylyev, Marta; Kuznetsova, Anastasiia; Begovać, Josip; Svedhem, Veronica; Clark, Andrew; Cozzi‐Lepri, Alessandro; Study, EuroSIDA

doi:10.1097/qai.0000000000002635

Cited by 21 publications

(32 citation statements)

References 30 publications

(40 reference statements)

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“…Overall, the prevalence of subjects with resistance at 2 or more classes (described as “heavily treatment-experienced patients” according to recent definitions) was 31%. [ 19 ] No patients had major mutations for DOR at baseline. However, a 50-year-old highly treated male (for whom DOR was combined with lenacapavir, dolutegravir, bDRV, and tenofovir alafenamide), showed the V108X mutation which causes a low-level reduction in susceptibility to DOR.…”

Section: Resultsmentioning

confidence: 99%

Real-life use of Doravirine in treatment-experienced people living with HIV: A multicenter Italian study

Mazzitelli¹,

Antoni

Castelli

et al. 2022

Medicine

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Use of doravirine (DOR), a new nonnucleoside reverse-transcriptase inhibitors recently approved for HIV treatment, is still unclear in clinical practice and real-life data are scarce.We retrospectively investigated the rationale for switching people with HIV to DOR-containing/-based regimens in a real-life cohort. Among 132 patients (68.9% males, median age 56 years), the main reasons to start DOR were prevention of toxicities (39.4%) and dyslipidemia (18.2%). DOR was combined with integrase inhibitors in 40.9% cases, and in 25.7% of patients, DOR was prescribed without availability of a genotypic resistance test.Twenty-four weeks after the switch to DOR-containing/-based regimens, no significant changes in CD4+ T-cell count, CD4/ CD8 ratio, detectable HIV-RNA, serum creatinine levels, and body weight were detected. By contrast, a significant reduction in lipids (both cholesterol and triglycerides) was observed in 52 patients for whom a follow-up assessment was available (P = .008 and .01, respectively).Our data confirmed that switching to DOR-containing/-based regimens may have a favorable impact on lipid profile and a neutral impact on weight gain. However, more data are needed to support its use in patients who do not have a genotypic test available or have an extensive nonnucleoside reverse-transcriptase inhibitors-associated resistance, as well as its use in a dual regimen, especially in combination with second-generation integrase inhibitors.

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Section: Resultsmentioning

confidence: 99%

Real-life use of Doravirine in treatment-experienced people living with HIV: A multicenter Italian study

Mazzitelli¹,

Antoni

Castelli

et al. 2022

Medicine

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“…According to these criteria, 16.1% of the included PWH were classified as HTE. There is no general consensus on the definition of HTE PWH in the literature or guidelines, and multiple descriptions are available based on virologic failure and prior and current ART patterns and/or resistance data [ 2 , 6 , 13 , 14 ]. Previous studies in which the definition of HTE included consideration of resistance and/or prior exposure to ART have suggested that the prevalence of HTE PWH in the United States is <6% [ 6 , 13–15 ].…”

Section: Discussionmentioning

confidence: 99%

“…A subset of PWH are heavily treatment-experienced (HTE), having experienced virologic failure on multiple different treatment regimens, and have limited remaining ART options because of multidrug resistance and intolerance to certain ART agents [ 1–5 ]. Treatment of HIV-1 in HTE PWH may be further complicated by factors such as advanced HIV disease with low CD4+ cell count (≤200 cells/mm 3 ), multiple comorbid medical conditions requiring concomitant medications, and treatment of or prophylaxis for opportunistic infections [ 1 , 2 , 5–7 ]. These individuals may be unable to achieve virologic suppression and are thus at risk of further disease progression and transmission of infection [ 1 ].…”

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confidence: 99%

Characterization of Heavily Treatment-Experienced People With HIV and Impact on Health Care Resource Utilization in US Commercial and Medicare Advantage Health Plans

Priest¹,

Hulbert

Gilliam³

et al. 2021

Open Forum Infectious Diseases

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Background This retrospective, administrative claims study aimed to describe clinical characteristics, healthcare resource utilization (HCRU), and costs of people with HIV (PWH) in US commercial and Medicare Advantage health plans by antiretroviral treatment (ART) experience and CD4+ cell count. Methods Data from the national Optum Research Database between January 1, 2014, and March 31, 2018, for adult PWH continuously enrolled 6 months before and ≥12 months after the first ART identified (follow-up) were summarized by treatment (heavily treatment experienced [HTE] with limited remaining ART options, treatment experienced but not HTE [non-HTE], or treatment naive starting a first antiretroviral regimen) and index CD4+ cell count (<200, 200-500, or >500 cells/mm3). Results Compared with non-HTE (n=7604) and treatment-naive PWH (n=4357), HTE PWH (n=2297) were older (53.5 vs 48.8 and 42.3 years), were more likely to have HIV-related emergency department visits (22.3% vs 12.4% and 18.6%) and inpatient stays (15.8% vs 7.1% and 10.3%), had a higher mean (SD) daily pill burden (9.7 [7.7] vs 5.1 [5.9] and 3.6 [5.3] pills/day), and a higher mortality rate (5.9% vs 2.9% and 2.3%) during follow-up (all P<0.001). More HTE (21.8%) and treatment-naive PWH (27.0%) had <200 CD4+ cells/mm 3 vs non-HTE PWH (8.0%; P<0.001). All-cause and HIV-related costs were higher among HTE PWH in all CD4+ cell count strata and treatment-naive PWH with CD4+ cell counts <200 cells/mm 3 vs non-HTE PWH in all CD4+ cell count strata. Conclusions Improved support and clinical monitoring of HTE PWH are needed to prevent worsening outcomes and increased costs.

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“…A retrospective cohort study of commercial and Medicare Advantage health plan enrollees in the USA between 2013 and 2019 found that 16.1% of 14 258 people living with HIV were HTE [4]. An ongoing cohort study of 22 000 Europeans living with HIV estimates that approximately 10% are HTE, with this figure rising from just 5.8% in 2010 to 8.9% in 2016 [5]. Conversely, a study of ART-experienced individuals with HIV living in the USA found that the number with limited remaining treatment options declined from 5.2%-7.8% in 2000-2006 to <1% from 2012 through 2017 [6].…”

Section: Introductionmentioning

confidence: 99%

Opening the door on entry inhibitors in HIV: Redefining the use of entry inhibitors in heavily treatment experienced and treatment‐limited individuals living with HIV

et al. 2022

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Introduction: Entry inhibitors are a relatively new class of antiretroviral therapy and are typically indicated in heavily treatment experienced individuals living with HIV. Despite this, there is no formal definition of 'heavily treatment experienced'. Interpretation of this term generally includes acknowledgement of multidrug resistance and reflects the fact that patients in need of further treatment options may have experienced multiple lines of therapy. However, it fails to recognize treatment limiting factors including contraindications, age-associated comorbidities, and difficulty adhering to regimens. Methods: This manuscript follows a roundtable discussion and aims to identify the unmet needs of those living with HIV who are in need of further treatment options, to broaden the definition of heavily treatment experienced and to clarify the use of newer agents, with an emphasis on the potential role of entry inhibitors, in this population.Results/Conclusions: Within the entry inhibitor class, mechanisms of action differ between agents; resistance to one subclass does not confer resistance to others. Combinations of entry inhibitors should be considered in the same regimen, and if lack of response is seen to one entry inhibitor another can be tried.When selecting an entry inhibitor, physicians should account for patient preferences and needs as well as agent-specific clinical characteristics. Absence of documented multidrug resistance should not exclude an individual from treatment with an entry inhibitor; entry inhibitors are a valuable treatment option for all individuals who are treatment limited or treatment exhausted. We should advocate for additional clinical trials that help define the role of entry inhibitors in people with exhausted/limited ART options other than drug resistance.

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Prevalence and Outcomes for Heavily Treatment-Experienced Individuals Living With Human Immunodeficiency Virus in a European Cohort

Abstract: Supplemental Digital Content is Available in the Text.

Cited by 21 publications

References 30 publications

Real-life use of Doravirine in treatment-experienced people living with HIV: A multicenter Italian study

Real-life use of Doravirine in treatment-experienced people living with HIV: A multicenter Italian study

Characterization of Heavily Treatment-Experienced People With HIV and Impact on Health Care Resource Utilization in US Commercial and Medicare Advantage Health Plans

Opening the door on entry inhibitors in HIV: Redefining the use of entry inhibitors in heavily treatment experienced and treatment‐limited individuals living with HIV

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