Browsing by Author "Ategeka, Gilbert"

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    Efficacy and Safety of Dolutegravir or Darunavir in Combination with Lamivudine plus either Zidovudine or Tenofovir for second-line Treatment of HIV Infection (NADIA): week 96 results from a Prospective, Multicentre, Open-label, Factorial, Randomised, Non-inferiority trial
    (The Lancet HIV, 2022) Paton, Nicholas I.; Musaazi, Joseph; Kityo, Cissy; Walimbwa, Stephen; Hoppe, Anne; Balyegisawa, Apolo; Mirembe, Grace; Lugemwa, Abbas; Ategeka, Gilbert; Mugerwa, Henry; Kambugu, Andrew
    WHO guidelines recommend dolutegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs) for second-line HIV therapy, with NRTI switching from first-line tenofovir to zidovudine. We aimed to examine whether dolutegravir is non-inferior to darunavir, the best-in-class protease inhibitor drug, and whether maintaining tenofovir in second-line therapy is non-inferior to switching to zidovudine. In this prospective, multicentre, open-label, factorial, randomised, non-inferiority trial (NADIA), participants with confirmed HIV first-line treatment failure (HIV-1 RNA ≥1000 copies per mL) were recruited at seven clinical sites in Kenya, Uganda, and Zimbabwe. Following a 2 × 2 factorial design and stratified by site and screening HIV-1 RNA concentration, participants were randomly assigned (1:1:1:1) to receive a 96-week regimen containing either dolutegravir (50 mg once daily) or ritonavir-boosted darunavir (800 mg of darunavir plus 100 mg of ritonavir once daily) in combination with either tenofovir (300 mg once daily) plus lamivudine (300 mg once daily) or zidovudine (300 mg twice daily) plus lamivudine (150 mg twice daily). The NRTI drugs allocated by randomisation were administered orally in fixed-dose combination pills; other drugs were administered orally as separate pills. The previously reported primary outcome was the proportion of participants with a plasma HIV-1 RNA concentration of less than 400 copies per mL at 48 weeks. Here, we report the main secondary outcome: the proportion of participants with a plasma HIV-1 RNA concentration of less than 400 copies per mL at 96 weeks (non-inferiority margin 12%). We analysed this outcome and safety outcomes in the intention-to-treat population, which excluded only those who were randomly assigned in error and withdrawn before receiving trial drugs. This study was registered at ClinicalTrials.gov, NCT03988452, and is complete.
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    Patient experiences of sexual dysfunction after transition to dolutegravir‑based HIV treatment in mid‑Western Uganda: a qualitative study
    (BMC Infectious Diseases, 2022) Zakumumpa, Henry; Kiguba, Ronald; Byomire Ndagije, Helen; Ategeka, Gilbert; Nambi Ssanyu, Jacquellyn; Kitutu, Freddy Eric
    The literature on dolutegravir (DTG)-based HIV treatment has focused on assessing therapeutic efficacy particularly with regard to viral load suppression. However, little empirical attention has been devoted to understanding the effects of DTG on quality of life, in particular sexual health and functioning in PLHIV. This study focused on understanding patient experiences of sexual dysfunction, after transition to DTG-based regimens in Rwenzori region in Mid-Western Uganda. Methods: We adopted a qualitative exploratory research design. Between August and September 2021, we conducted sixteen in-depth interviews and six focus group discussions (48 participants) with patients reporting ‘new’ sexual dysfunction after transition to DTG-based regimens at seven health facilities in mid-Western Uganda. Data were analyzed by thematic approach. Results: Decreased libido was reported in both sexes of patients within weeks of transition to DTG-based regimens. Diminished interest in sex was more frequently reported among women while men complained of a marked reduction in the frequency of sex. Women reported loss of psycho-social attraction to their long-term male partners. Erectile dysfunction was common among men in this sample of patients. Patients described their experiences of sexual dysfunction as an affront to their socially-constructed gender identities. Patients described tolerating sexual adverse drug reactions (ADRs) as a necessary tradeoff for the extension in life granted through antiretroviral therapy. A number of women reported that they had separated from their spouses as a result of perceived drug-induced sexual dysfunction. Marital strife and conflict arising from frustration with sexual-partner dysfunction was frequently reported by participants in both sexes. Several participants indicated experiencing insecurity in their heterosexual relationships due to difficulties in sexual functioning. Conclusion: Sexual dysfunction following transition to DTG-based regimens is common in both sexes of PLHIV, who indicated that they had no prior experience of difficulties in sexual health. Our findings demonstrate that sexual ADRs negatively impact self-esteem, overall quality of life and impair gender relations. DTG-related sexual health problems merit increased attention from HIV clinicians. Further research is warranted to assess the prevalence of DTG-associated sexual dysfunction in patients in Uganda.