Browsing by Author "Ahimbisibwe, Grace Miriam"

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    Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial
    (The Lancet HIV, 2022-07-19) Turkova, Anna; Bwakura-Dangarembizi, Mutsa F.; Kekitiinwa, Adeodata R.; Lugemwa, Abbas; Ahimbisibwe, Grace Miriam; Burger, David M.
    Children with HIV-associated tuberculosis (TB) have few antiretroviral therapy (ART) options. We aimed to evaluate the safety and pharmacokinetics of dolutegravir twice-daily dosing in children receiving rifampicin for HIV-associated TB.
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    Neuropsychiatric manifestations and sleep disturbances with dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial
    (The Lancet Child & Adolescent Health, 2023) Anna, Turkova; Ellen, White; Adeodata, R. Kekitiinwa; Mumbiro, Vivian; Kaudha, Elizabeth; Afaaf, Liberty; Ahimbisibwe, Grace Miriam; Moloantoa, Tumelo; Ussanee, Srirompotong; Nozibusiso, Rejoice Mosia; Thanyawee, Puthanakit; Kobbe, Robin; Clàudia, Fortuny; Kataike, Hajira; Bbuye, Dickson; Sathaporn, Na-Rajsima; Alexandra, Coelho; Lugemwa, Abbas; Bwakura-Dangarembizi, Mutsa F.; Nigel, Klein; Hilda, A. Mujuru; Kityo, Cissy; Mark, F. Cotton; Rashida, A. Ferrand; Carlo, Giaquinto; Pablo, Rojo; Avy, Violari; Diana, M. Gibb; Deborah, Ford
    Cohort studies in adults with HIV showed that dolutegravir was associated with neuropsychiatric adverse events and sleep problems, yet data are scarce in children and adolescents. We aimed to evaluate neuropsychiatric manifestations in children and adolescents treated with dolutegravir-based treatment versus alternative antiretroviral therapy. Methods This is a secondary analysis of ODYSSEY, an open-label, multicentre, randomised, non-inferiority trial, in which adolescents and children initiating first-line or second-line antiretroviral therapy were randomly assigned 1:1 to dolutegravir-based treatment or standard-of-care treatment. We assessed neuropsychiatric adverse events (reported by clinicians) and responses to the mood and sleep questionnaires (reported by the participant or their carer) in both groups. We compared the proportions of patients with neuropsychiatric adverse events (neurological, psychiatric, and total), time to first neuropsychiatric adverse event, and participant-reported responses to questionnaires capturing issues with mood, suicidal thoughts, and sleep problems. Findings Between Sept 20, 2016, and June 22, 2018, 707 participants were enrolled, of whom 345 (49%) were female and 362 (51%) were male, and 623 (88%) were Black-African. Of 707 participants, 350 (50%) were randomly assigned to dolutegravir-based antiretroviral therapy and 357 (50%) to non-dolutegravir-based standard-of-care. 311 (44%) of 707 participants started first-line antiretroviral therapy (ODYSSEY-A; 145 [92%] of 157 participants had efavirenz-based therapy in the standard-of-care group), and 396 (56%) of 707 started second-line therapy (ODYSSEY-B; 195 [98%] of 200 had protease inhibitor-based therapy in the standard-of-care group). During follow-up (median 142 weeks, IQR 124–159), 23 participants had 31 neuropsychiatric adverse events (15 in the dolutegravir group and eight in the standard-of-care group; difference in proportion of participants with ≥1 event p=0·13). 11 participants had one or more neurological events (six and five; p=0·74) and 14 participants had one or more psychiatric events (ten and four; p=0·097). Among 14 participants with psychiatric events, eight participants in the dolutegravir group and four in standard-of-care group had suicidal ideation or behaviour. More participants in the dolutegravir group than the standard-of-care group reported symptoms of self-harm (eight vs one; p=0·025), life not worth living (17 vs five; p=0·0091), or suicidal thoughts (13 vs none; p=0·0006) at one or more follow-up visits. Most reports were transient. There were no differences by treatment group in low mood or feeling sad, problems concentrating, feeling worried or feeling angry or aggressive, sleep problems, or sleep quality.
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    Viral Load suppression after intensive adherence counselling among HIV infected adults at Kiswa Health Centre, Kampala: A retrospective cohort study. Secondary data analysis
    (Research Square, 2022) Nakaye, Catherine; Mukiza, Nelson; Mawanda, Denis; Kataike, Hajira; Kaganzi, Hellen; Ahimbisibwe, Grace Miriam; Businge, Gerald Bright; Kyambadde, Raymonds Crespo; Nakalega, Rita
    The Joint United Nations Programme on HIV/AIDS through the 95-95-95 target requires 95% of people with HIV infection (PWHIV) on antiretroviral treatment (ART) to be virally suppressed. Viral Load (VL) non-suppression has been found to be associated with suboptimal ART adherence, and Intensive Adherence Counselling (IAC) has been shown to lead to VL re-suppression by over 70% in PWHIV on ART. Currently, there is data paucity on VL suppression after IAC in adult PWHIV in Uganda. This study aimed to evaluate the proportion of VL suppression after IAC and associated factors among adult PWHIV on ART at Kiswa Health Centre in Kampala, Uganda. Methods Study was a retrospective cohort design and employed secondary data analysis to review routine program data. Medical records of adult PWHIV on ART for at least six months with VL non-suppression from January 2018 to June 2020 at Kiswa HIV clinic were examined in May 2021. Descriptive statistics were applied to determine sample characteristics and study outcome proportions. Multivariable modified Poisson regression analysis was employed to assess predictors of VL suppression after IAC. Results Analysis included 323 study participants of whom 204 (63.2%) were female, 137 (42.4%) were between the age of 30 and 39 years; and median age was 35 years (interquartile range [IQR] 29–42). Participant linkage to IAC was 100%. 48.6% (157/323) of participants received first IAC session within 30 days or less after unsuppressed VL result. 66.78% (205/307) of participants who received recommended three or more IAC sessions achieved VL suppression. 34% of participants completed three IAC sessions in recommended 12 weeks. Receipt of three IAC sessions (ARR = 1.33, 95%CI: 1.16–1.53, p < 0.001) and having baseline VL of 1,000–4,999 copies/ml (ARR = 1.47, 95%CI: 1.26–1.73, p < 0.001) was significantly associated with VL suppression after IAC. Conclusion VL suppression proportion of 66.78% after IAC in this population was comparable to 70%, the percentage over which adherence interventions have been shown to cause VL re-suppression. However, timely IAC intervention is needed from receipt of unsuppressed VL results to IAC process completion. Resistance testing should be performed for PWHIV with persistent VL non-suppression after IAC for apt ART regimen switch.