ABSTRACT
Background: Evidence supports switching DTG/3TC/ABC in patients complaining about insomnia. However, there is unknown if the benefit observed could also apply to non-complaining patients displaying sleep disturbances in self-reported questionnaires used as screening tools, such as the Pittsburg sleep quality index (PSQI). Methods: We designed the DETOX study, as an open label, randomized (1:1), multicenter, pilot clinical trial, to evaluate the reversibility of sleep disturbances detected with the PSQI in well-suppressed patients on DTG/3TC/ABC (>12 weeks) not complaining of insomnia. Participants with a PSQI >5 were randomized either to switch to DRV/c/FTC/TAF for 8 weeks (arm 1) or either to continue 4 weeks on DTG/3TC/ABC and then switch to DRV/c/FTC/TAF for 8 weeks (arm 2). Every 4 weeks, participants self-reported using the PSQI, the Hospital Anxiety & Depression Scale (HADS) and a questionnaire exploring about 11 neuropsychiatric adverse events (AE). Raw scores on PSQI and HADS, along with an average score from adding the grade of each neuropsychiatric AE, were normalized (0-100). Then we compared changes at week 4 (between study arms) and after participants completed 4 and 8 weeks on DRV/c/FTC/TAF. Additional analyses included virological outcomes. Results: The study included 72 participants (arm 1: n=37;arm 2: n=35). Both arms had similar baseline characteristics. Three discontinued prematurely before week 4 (arm 1: none;arm 2: 1 COVID-19, 1 loss of follow up (LFU) and 1 consent withdrawal). At week 4, we observed significant improvements (arm 1 vs. arm 2) in PSQI (mean change±SD: 11.5±10.2 vs. 0.6±8.9;p<0.001), HADs anxiety scale (14±16.9 vs. 1.9±15.6;p=0.003) and AE (13.7±13.3 vs. 1.3±8.6;p<0.001) scores. Sixty-nine participants switched to DRV/c/FTC/TAF: 37 at baseline (arm 1) and 32 at week 4 (arm 2). All except 3 who discontinued prematurely (2 LFU and 1 due to AE nausea) completed 8 weeks of follow up. Pooled analysis showed significant improvements in most neuropsychiatric scores and symptoms (table), with no virologic failures reported. After switching to DRV/c/FTC/TAF, 26 participants (37.7%) reported any AE (all grade 1-2). Most common AE were headache (7.2%) and dyslipidemia (7.2%). Conclusion: Sleep disturbances detected through self-reported screening tools seem to be associated with patients on DTG/3TC/ABC not complaining of insomnia. These disturbances, among other neuropsychiatric symptoms such as anxiety or depression, could improve after switching to DRV/c/FTC/TAF.
ABSTRACT
Background: We compared the characteristics and clinical outcomes of hospitalized patients with COVID-19 with and without HIV infection (HIV-pos and HIV-neg) in Spain during the first wave of the pandemic. Methods: HIV-pos were identified by reviewing clinical records and laboratory registries of 10,922 patients in active-follow-up within the Spanish HIV Research Network (CoRIS) up to June 30, 2020. Each HIV-pos was matched with 5 HIV-neg of the same age and sex randomly selected from COVID-19@Spain, a multicenter cohort of 4,035 patients hospitalized with PCR confirmed COVID-19 in Spain (Clin Microbiol Infect 2020;26:1525-36). Data were collected with the ISARIC-WHO Core case report form (https://isaric.org/document/COVID-19-crf/). The COVID-19 SEIMC score (predictive of 30-day mortality), based on age, sex, dyspnea, O2 saturation, neutrophil-to-lymphocyte ratio, and estimated glomerular filtration rate, was calculated at admission in all patients (ESCMID Conference on Coronavirus Disease, 2020, Abstract#00513). Outcomes included the need for mechanical ventilation and all-cause in-hospital mortality. Results: Forty-five patients with PCR confirmed COVID-19 were identified in CoRIS, 21 of which were hospitalized. A total of 105 age/sex-matched controls were selected from COVID-19@Spain. The median age in both groups was 53 (Q1-Q3, 46-56) years, and 90.5% were men. In HIV-pos, 19.1% were IDUs, 95.2% were on ART, 94.4% had HIV-RNA < 50 copies/mL, and the median (Q1-Q3) CD4+ count was 595 (349-798) cells/mm3. No statistically significant differences were found between groups in number and type of comorbidities, presenting signs and symptoms, laboratory parameters, and radiology findings. The median (Q1-Q3) COVID-19 SEIMC score on admission was 4 (2-7) and 5 (3-7) in HIV-pos and HIV-neg, respectively;P=.890. Corticosteroids were administered to 33.3% and 27,4% HIV-pos and HIV-neg, respectively;P=.58. Remdesivir was administered to 0 and 2.9% of HIV-pos and HIV-neg, respectively;P=.426. During admission, 9.5% HIV-pos and 23.3% HIV-neg underwent mechanical ventilation;P=.158. In-hospital mortality was 9.5% in HIV-pos and 11.4% in HIV-neg;P=.800. Conclusion: Our findings suggest that well-controlled HIV infection does not modify the clinical presentation or worsen clinical outcomes in patients hospitalized with COVID-19. (Figure Presented).
ABSTRACT
Background: Within a prospective cohort of people with HIV (PWH) in Spain, we assessed the prevalence of SARS-CoV-2 antibodies (Ab), the proportion of asymptomatic COVID-19, and identified predictors of infection. Methods: We determined SARS-CoV-2 Ab in plasma samples collected from April 1st to September 30th, 2020, from enrollees in the Spanish HIV Research Network Cohort (CoRIS), a prospective national cohort of PWH, naive to ART at study entry, seen for the first time from January 1st, 2004. Samples were stored at-80°C in the Spanish HIV BioBank, and serology was performed using the Platelia SARS-CoV-2 Total Ab assays (BioRad, Hercules, CA, USA). Illness severity (NIH criteria) was assessed by medical records review and, if needed, participant interviews. Multivariable logistic regression analysis was used to identify predictors of seropositivity among the following variables: sex, age, country of birth, education level, comorbidities (hypertension, chronic heart disease, diabetes, non-AIDS related cancer, chronic kidney disease, cirrhosis), route of HIV acquisition, prior AIDS, CD4+ cell count, HIV viral load, and N(t)RTI backbone. Results: During the study period, blood samples were collected and stored in the HIV BioBank from 1,076 consecutive PWH in CoRIS: 88.0% male at birth, median age 43 yr., 72.3% MSM, 97.7% on ART, median CD4+ 688 cells/mm3, 91.4% undetectable HIV viral load. SARS-CoV-2 Ab were detected in 91 PWH, for a seroprevalence of 8.5% (95%CI: 6.9%-10.3%). A total of 41 PWH (45.0%) had asymptomatic infections;the disease was mild in 43 (47.3%), moderate in 4 (4.4%), severe in 3 (3.3%), and 0 critical. Seven PWH (7.7%) were hospitalized. COVID-19 was confirmed by RT-PCR in 22 (24.2%) PWH. Variables independently associated with SARS-CoV-2 seropositivity were birth in Latin American (LA) Countries vs. Spain (adjusted odds ratio [aOR]: 2.34, 95%CI: 1.42-3.85;P=.001);arterial hypertension (aOR: 1.63, 95%CI: 1.00-2.67;P=.050);and therapy with tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC) vs tenofovir alafenamide (TAF)/FTC as the N(t)RTI backbone (aOR: 0.32, 95%CI: 0.12-0.84;P=.021). (Table). Conclusion: A large proportion of SARS-CoV-2 infections among PWH were asymptomatic. Birth in LA-countries and arterial hypertension were associated with increased risk of SARS-CoV-2 seropositivity. Our analysis, adjusted by comorbidities and other variables, suggest that TDF/FTC may prevent SARS-CoV-2 infection among PWH. (Figure Presented).