Bictegravir/emtricitabine/tenofovir alafenamide as first-line treatment in naïve HIV patients in a rapid-initiation model of care: BIC-NOW clinical trial.

OBJECTIVE: Multiple strategies have been utilised to reduce the incidence of HIV, including PrEP and rapid antiretroviral therapy initiation. The study objectives were to evaluate the efficacy, safety, satisfaction, treatment adherence, and system retention obtained with rapid initiation of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in naïve patients. METHODS: This phase IV, multicenter, open-label, single-arm, 48-week clinical trial enrolled patients between January 2020 and June 2022. Adherence to treatment was evaluated with the SMAQ questionnaire and patient satisfaction with the EQ-5D. RESULTS: Two hundred eight participants were enrolled with mean age of 35.6 years; 87.6% were males; mean CD4 count was 393.5 cells/uL (<200 cells/uL in 22.1%); viral load log was 5.6 (VL>100 000 cop/mL in 43.3%); 22.6% had AIDS, and 4.3% were coinfected with HBV. BIC/FTC/TAF was initiated on the day of their first visit to the HIV specialist in 98.6% of participants, and 9.6% were lost to follow-up. The efficacy at week 48 was 84.1 % by intention-to- treat (ITT), 94.6% by modified ITT, and 98.3% by per protocol analysis. The regimen was discontinued in two subjects (0.9%) during week 1 for grade 3 adverse events. Treatment adherence (weeks 4 [90%, IQR: 80-99%] vs. 48 [90%, IQR: 80-95%; P = 0.49]) and patient satisfaction (weeks 4 [90%, IQR: 80-99%] vs. 48 [90%, IQR: 80-95 P = 0.49]) rates were very high over the 48- week study period. CONCLUSIONS: BIC/FTC/TAF is an appropriate option for rapid ART initiation in naïve HIV patients, offering high efficacy, safety, durability, treatment adherence, retention in the healthcare system, and patient satisfaction. Number Clinical Trial registration: NCT06177574.

No differences in quality of life between men and women undergoing HIV antiretroviral treatment. Impact of demographic, clinical and psychosocial factors.

INTRODUCTION: The health-related quality of life (HRQL) is therefore a highly important tool for the evaluation of the health status of HIV positive patients. However, very little information is available about the differences between HRQL in men and women. The aim of this study is to analyse gender differences in HRQL in HIV positive patients. METHODOLOGY: A sample group of 540 patients infected with HIV and undergoing antiretroviral treatment was studied. All of these patients attended outpatient appointments in the infectious disease units of four hospitals in the southern Spanish region of Andalusia. HRQL was measured using the MOS-HIV health survey, which had been validated for use in this setting. RESULTS: One hundred forty-nine women (26.6%) and 411 men (73.4%) took part in the study. On the whole, the women were younger, more likely to be married and had more children. The men, on the other hand, were more likely to present with coinfection with hepatitis C, have a history of intravenous drug use, be undergoing methadone treatment or have lower levels of CD4. Both the overall average scores and the scores for specific dimensions were higher in women than in men. When these scores were adjusted using different clinical variables, these differences were not statistically significant. Amongst the women, psychic morbidity, longer periods of time as HIV carriers and low levels of social support were linked to lower MHS and PHS scores. An independent link was established between older age and a lower PHS score. Amongst the men, psychic morbidity, difficulty in taking tablets, intravenous drug use and low levels of social support were linked to lower PHS and MHS scores. AIDS and a higher number of antiretroviral medicines were linked to a lower PHS score. CONCLUSIONS: By carrying out an analysis according to gender it is possible to see different factors associated with a poorer quality of physical and mental health. This makes it possible to identify areas which could be developed and to optimise results in terms of patients' health.