Effectiveness of the combination elvitegravir/cobicistat/tenofovir/emtricitabine (EVG/COB/TFV/FTC) plus darunavir among treatment-experienced patients in clinical practice: a multicentre cohort study.

BACKGROUND: The aim of this study was to investigate the effectiveness and tolerability of the combination elvitegravir/cobicistat/tenofovir/emtricitabine plus darunavir (EVG/COB/TFV/FTC + DRV) in treatment-experienced patients from the cohort of the Spanish HIV/AIDS Research Network (CoRIS). METHODS: Treatment-experienced patients starting treatment with EVG/COB/TFV/FTC + DRV during the years 2014-2018 and with more than 24 weeks of follow-up were included. TFV could be administered either as tenofovir disoproxil fumarate or tenofovir alafenamide. We evaluated virological response, defined as viral load (VL) < 50 copies/ml and < 200 copies/ml at 24 and 48 weeks after starting this regimen, stratified by baseline VL (< 50 or ≥ 50 copies/ml at the start of the regimen). RESULTS: We included 39 patients (12.8% women). At baseline, 10 (25.6%) patients had VL < 50 copies/ml and 29 (74.4%) had ≥ 50 copies/ml. Among patients with baseline VL < 50 copies/ml, 85.7% and 80.0% had VL < 50 copies/ml at 24 and 48 weeks, respectively, and 100% had VL < 200 copies/ml at 24 and 48 weeks. Among patients with baseline VL ≥ 50 copies/ml, 42.3% and 40.9% had VL < 50 copies/ml and 69.2% and 68.2% had VL < 200 copies/ml at 24 and 48 weeks. During the first 48 weeks, no patients changed their treatment due to toxicity, and 4 patients (all with baseline VL ≥ 50 copies/ml) changed due to virological failure. CONCLUSIONS: EVG/COB/TFV/FTC + DRV was well tolerated and effective in treatment-experienced patients with undetectable viral load as a simplification strategy, allowing once-daily, two-pill regimen with three antiretroviral drug classes. Effectiveness was low in patients with detectable viral loads.

Knowledge and Perceived Emotions Regarding an Anal Cancer Preventive Program in People Diagnosed With HIV: A Qualitative Study.

BACKGROUND: To the best of our knowledge, no studies have yet examined the emotional repercussions of the care processes among people infected with the human immunodeficiency virus who participate in preventive anal cancer screening programs. OBJECTIVE: This study aimed to explore the knowledge, emotions, sexuality, barriers, and facilitators perceived by this patient group during the process of anal cancer screening and diagnosis. METHODS: Detailed, semistructured, qualitative interviews were completed with 17 men and 3 women to explore their knowledge, experiences, and emotions regarding the screening process. Purposive sampling was conducted on the basis of age, gender, and type of lesion diagnosed in the anal biopsy. RESULTS: Four major themes were identified: 1) knowledge of the disease and its treatment, 2) emotions perceived by the patients, 3) the influence of screening on sexual practices, and 4) facilitators and obstacles during the care provision process. Patients reported appropriate knowledge of anal cancer and human papillomavirus. Predominant emotions were worry and fear with avoidance as one of the coping strategies. CONCLUSION: These results suggest that communication of information and clinical results can be improved. IMPLICATION FOR PRACTICE: Understanding the facilitators and barriers to the program will allow the integration of interventions designed to improve healthcare provision into direct care.

Evaluation of the validity of the HPV viral load compared to conventional techniques for the detection of high-grade anal intraepithelial lesions in men with HIV who have sex with men.

Background: The incidence of high-grade anal intraepithelial lesions (HSILs) has increased in recent years among men who have sex with men with human immunodeficiency virus (HIV). This work evaluated the validity of the human papilloma virus viral load (HPV-VL) versus cytological and qualitative HPV results to detect HSILs. Methods: From May 2017 to January 2020, 93 men who have sex with men and HIV were included in an anal cancer screening program from the Infectious Diseases Unit at a tertiary-care hospital in Alicante (Spain). The gold-standard for the screening of anal HSILs is the anal biopsy using high-resolution anoscopy. The diagnostic methods compared against gold-standard were HPV-16-VL, HPV-18-VL, and HPV-16-18-VL co-testing, anal cytology, and qualitative HPV detection. The receiver operating characteristic (ROC) curve and cut-off points for HPV-VL were calculated. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and Cohen's Kappa coefficient (κ) were also calculated. Results: The mean patient age was 44.6 ± 9.5 years. All of them received antiretroviral treatment, 96.8% had an HIV viral load of <50 copies/mL and 17.2% had a previous diagnosis of AIDS. The diagnosis of the anal biopsies were: 19.4% (n = 18) HSIL, 29.1% (n = 27) LSIL, and 51.6% (n = 48) negative. An HPV-16-VL >6.2 copies/cell was detected in the HSIL biopsy samples (p = 0.007), showing a sensitivity of 100% and a specificity of 46.2%. HPV-18-VL and HPV16-18-VL co-testing showed a sensitivity of 75% and 76.9% and a specificity of 72.7% and 61.3%, respectively. The highest PPV was 50% obtained with the cytology and HPV-18-VL. The HPV-16-VL showed a NPV of 100%, followed by 88.9% in the HPV-18-VL and 87% in the abnormal cytology. Cohen's Kappa coefficient were: HPV-18-VL (κ = 0.412), abnormal cytology (κ = 0.353) and HPV-16-VL (κ = 0.338). Conclusions: HPV-VL testing improved the detection sensitivity but not the specificity for HSIL biopsies compared to anal cytology and the qualitative detection of HPV. In men who have sex with men and HIV the HPV-VL could be an useful tool for diagnosis of HSILs in anal cancer screening programs. Further studies will be needed to evaluate the clinical implications of HPV-VL in these programs.

The Role of Mental Health Conditions in the Diagnosis of Neurocognitive Impairment in People Living with HIV.

The aims of the present study were to evaluate the prevalence of undiagnosed mental health conditions (UMHC) in people living with HIV (PLWHIV) on antiretroviral treatment and with long-term suppressed HIV viremia, and its association with neurocognitive impairment (NCI). A cross-sectional observational study on HIV subjects, ≥18 years old, on stable antiretroviral treatment and with HIV viral load <50 copies/mL was carried out. Patients with known comorbidities, substances abuse, anxiety or depression were excluded. UMHC were evaluated by the Millon Clinical Multiaxial Inventory-III and NCI by Frascati criteria. The association between NCI and sociodemographic, clinical HIV variables and mental health conditions was analyzed. Further, the relationship between mental health conditions scores and NCI diagnosis was evaluated. Eighty patients were included, 37.5% had at least one undiagnosed mental health condition, and 26.3% had NCI. The most frequent mental health conditions were: anxiety (21.3%); bipolar disorder (11.3%); and substance dependence (8.8%). Only longer time since HIV diagnosis (p = 0.030) and at least one mental health condition diagnosis (p = 0.002) showed an association with NCI. Participants with NCI presented higher scores in anxiety, alcohol dependence and post-traumatic stress. Undiagnosed mental health conditions are frequent in PLWHIV. These disorders cannot be identified by HIV clinicians or basic screening questionnaires, and they are not usually self-reported by patients. UMHC could act as confounders in the evaluation of NCI.