Outcomes by sex following treatment initiation with darunavir/cobicistat in a large Spanish cohort of the CODAR study (GeSIDA 9316)

2019 ◽  
Vol 74 (10) ◽  
pp. 3044-3048
Author(s):  
M J Pérez Elías ◽  
B Alejos ◽  
M J Vivancos ◽  
E Ribera ◽  
M J Galindo ◽  
...  

Abstract Background Few women have been included in darunavir/cobicistat clinical development studies, and hardly any of them were antiretroviral experienced or treated with anything other than triple-based therapies. Objectives Our aim was to increase our knowledge about women living with HIV undergoing darunavir/cobicistat-based regimens. Methods A multicentre (21 hospitals), retrospective study including a centrally selected random sample of HIV-1 patients starting a darunavir/cobicistat-based regimen from June 2014 to March 2017 was planned. Baseline characteristics, 24 and 48 week viral load response (<50 copies/mL), CD4+ lymphocyte count increase, time to change darunavir/cobicistat and adverse event occurrence were all compared by sex. The study was approved by each of the 21 ethics committees, and patients signed informed consent. Results Out of 761 participants, 193 were women. Similar characteristics were found for both sexes, except that the women had a longer duration of HIV infection (P = 0.001), and were less frequently pre-treated with darunavir/cobicistat in their previous regimen (P = 0.02). The main reason for using a darunavir/cobicistat-based regimen was simplification, without differences by sex, while monotherapy seems to be more frequently prescribed in women than in men (P = 0.067). The main outcomes, HIV viral load response, CD4+ lymphocyte count increase at 24 or 48 weeks, occurrence of adverse events, main reasons for changing and time to the modify darunavir/cobicistat regimen, did not show differences between the sexes. Conclusions No sex disparities were found in the main study outcomes. These results support the use of a darunavir/cobicistat-based regimen in long-term pre-treated women. Clinical Trial.gov No. NCT03042390.

2021 ◽  
Vol 21 (3) ◽  
pp. 995-1002
Author(s):  
Esra Zerdali ◽  
İnci Yılmaz Nakir ◽  
Serkan Sürme ◽  
Uğurcan Sayılı ◽  
Mustafa Yıldırım

Background/aim: Tuberculosis (TB) is one of the most common chronic infectious conditions causing mortality and se- vere outcomes, particularly in people living with HIV/AIDS (PLWHA). In this study, we aimed to determine the prevalence and predictors of TB among PLWHA. Materials and methods: We conducted a retrospective and single-center study of adults (≥18 years) PLWHA registered at our tertiary teaching and research hospital between 2000 and 2016. Results: A total of 711 PLWHA were included. Of whom, 633 (89.0%) were male. Mean age was 36.53 ±11.55 years (range, 17-79). Thirty-eight (5.3%) patients were diagnosed with active TB. TB development was associated with low CD4+ lymphocyte count (p<0.001), high viral load (p=0.040) and alcohol consumption (p=0.004) but no association with age (p=0.392), gender (p=0.928) and duration since anti-retroviral therapy initiation (p=0.788) was found. Also, a receiver operating characteristic analysis showed that the area under the curves of CD4+ lymphocyte count as a predictor for TB development in PLWHA was 0.717 (p<0.001). Conclusion: There are still clinical challenges to predict TB diagnosis. However, CD4+ lymphocyte count and viral load may be considered as valuable predictors for TB development. Also, community strategies to reduce harmful effect of alco- hol use should be developed. Keywords: Tuberculosis; HIV viral load; CD4 cell counts.


2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Teshale Ayele Mega ◽  
Firehiwot Belayneh Usamo ◽  
Getandale Zeleke Negera

Background. Both abacavir- (ABC-) based and zidovudine- (AZT-) based regimens are widely utilized for managing HIV infection in children. Unfortunately, there is a lack of data regarding their immunological response and associated risk factors in Ethiopia. Methods. A retrospective hospital-based cohort study was conducted on HIV-infected children in Jimma Medical Center (JMC). A total of 179 records were reviewed by including data from November 2015 to April 2017. Data were collected on sociodemographic, clinical characteristics of patients and drug-related variables. Data analysis was done using STATA 13.1. Mixed-effect linear regression was performed to assess the difference in CD4+ changes between groups adjusting for baseline characteristics. The change in predicted CD4 count attributed to each regimen was also assessed by marginal analysis. P<0.05 for slope of the random-effect linear regression was used as an indicator for the presence of association. Result. Of 179 patients, 98 (54.7%) were females. The mean (±SD) duration of follow-up was 939.8 ± 478.3 and 984.92 ± 453.1 days for ABC and AZT groups, respectively. AZT group had a significant CD4+ count gain per visit compared with their ABC counterparts ((β = 20.51, 95% CI [6.37–34.65]), P=0.004) over time. The regimen AZT + 3TC + LPV/r tended to have an excellent predicted CD4+ lymphocyte count change relative to all other regimens, while ABC + 3TC + LPV/r had the least immunologic recovery (margins 338.0 cells/mm3 versus 249.13 cells/mm3 (P<0.001)). Baseline CD4+ lymphocyte count, ART group, WHO clinical stages, and viral load were independent predictors for CD4+ change overtime. Conclusion. AZT-based regimens seem to have better immunological response compared to ABC-based regimens. Immunologic response was described worse in patients with a viral load of >1000copies/ml, low baseline CD4+ count, advanced WHO clinical stages, and ABC-containing regimens. Further study is needed to clarify these aspects.


AIDS Care ◽  
2004 ◽  
Vol 16 (4) ◽  
pp. 446-457 ◽  
Author(s):  
E. Castillo ◽  
A. Palepu ◽  
A. Beardsell ◽  
L. Akagi ◽  
B. Yip ◽  
...  

2003 ◽  
Vol 26 (1) ◽  
pp. 101-107 ◽  
Author(s):  
Penelope R Smith ◽  
Liat Sarner ◽  
Maurice Murphy ◽  
Beki James ◽  
Janice M Thomas ◽  
...  

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