ABSTRACT
Introduction: BICSTaR is an ongoing, multinational, observational cohort study evaluating B/F/TAF in ART therapy-naïve (TN) and ART-experienced (TE) PLWH. The BICSTaR population has a high baseline prevalence of comorbidities (particularly neuropsychiatric). PROs were prospectively collected. Materials and Methods: One hundred eighty TN/955 TE participants were considered for the 12M analysis (cut-off Feb 2021, including people enrolled from Jun 2018 to Sept 2020, i.e. partially during the COVID- 19 pandemic). PRO measures: Adherence [visual analogue scale (VAS)];physical/mental health [short form 36 (SF-36) questionnaire: Aggregated physical/mental component summary (PCS/MCS) scores;HIV-symptom index (HIV-SI;symptoms dichotomised into bothersome/not bothersome);HIV treatment satisfaction questionnaire (HIVTSQ;TE only);physician visits. VAS/SF-36/HIV-SI: Analysis population restricted to participants with questionnaires completed at both baseline/12M. SF-36/HIV-SI/HIVTSQ were described for participants with/without prior/ongoing neuropsychiatric comorbidities (TE only as TN subgroup was small). Results: Adherence to treatment was high at baseline (TE) and was maintained at 12M after switch to B/F/TAF [Table 1 (T1)]. Statistically significant improvements in PCS/MCS scores were observed in TN participants at 12M (p<0.05);scores remained stable in TE participants (Figure 1). The medyan (Q1, Q3) number of bothersome symptoms in TN participants declined from 6 (2, 9) at baseline to 2 (0, 6) at 12M (p<0.001;T1);TE, no change in absolute count. Statistically significant reductions in the frequency of several bothersome symptoms were reported in TN participants (p<0.05) (TE: No statistically significant changes). Treatment satisfaction was high at baseline (TE), with improvements observed at 12M following switch to B/F/TAF (p<0.001) (T1). Physician visits are shown (T1). In TE participants with baseline prior/ongoing neuropsychiatric comorbidities [275/955 (29%)], similar PRO trends were seen. Conclusion: In this real-world cohort of PLWH with a high prevalence of comorbidities (and in the setting of a global pandemic), patient-reported adherence, physical/mental health, bothersome symptoms, and treatment satisfaction were maintained/showed improvements during 12M of B/F/ TAF treatment.
ABSTRACT
Introduction: Headache is one of the most frequent symptoms of coronavirus disease 2019 (Covid-19). Most of the published series and cases described hospitalized patients, which could bias the results because of a more severe Covid-19. Objectives: In the present study we aim to describe the clinical phenotype of headache attributed to Covid-19 (HAC-19) including the full spectrum of patients, including cases managed both in primary care and hospital care. Methods:We screened the presence of headache all consecutive patients with a confirmed diagnosis of Covid-19, since the first hospitalized patient (March 8th, 2020) until April 11th. Patients with headache and capability to describe the headache phenotype were invited to participate. Diagnosis was confirmed by polymerase chain reaction test in all patients. A physician conducted a structured interview including demographic and clinical variables. Local ethics review board approved the study (PI 20- 1738). Results: A total of 138/576 (26.0%) hospitalized patients and 408/1690 (24.1%) primary care patients described headache, being.8 included in the study 105 and 352 of them. Mean age was 52.1±15.6 years, being 329 (72.0%) female, and 151 (33.0%) had pneumonia. Prior history of headache was described by 223 (48%) of patients, being migraine in 83 (18.2%). Headache was the first Covid-19 symptom in 126 (27.6%) patients and the mean duration of headache was 12.8 (16.1) days. The most frequent concomitant symptoms were olfactory disorders in 268 (58.6%) cases, followed by asthenia 335 (73.3%), cough 296 (64.8%), fever 259 (56.7%), and myalgia 223 (48.8%). Headache was the most bothersome Covid- 19 symptom in 69 (15.1%) cases, being the mean intensity 6.9±1.7. Patients estimated that headache allowed them to do 49.1±32.6% of their planned activities because of it. The headache was holocranial in 335 (73.3%), with frontal topography in 244 (53.4%), followed by temporal (121 (26.5%) and periocular in 97 (21.2%). Quality of pain was oppressive in 323 (70.7%) and throbbing in 66 (14.1%). Patients described avoidance of routine physical activity in 288 (63.0%) cases, photophobia in 150 (32.8%) cases, phonophobia in 146 (31.9%), and nausea in 69 (15.1%). The most frequently used symptomatic medication was paracetamol in 379 (82.9%), followed by ibuprofen in 70 (15.3%) and metamizole in 48 (10.5%). Conclusion: Headache is a frequent symptom in Covid- 19 disease. The clinical phenotype combines features from both tension-type headache and migraine, with moderate intensity and significant disability. A quarter of patients described headache as the first Covid-19 symptom.