A randomized comparison of health-related quality of life outcomes of dolutegravir versus efavirenz-based antiretroviral treatment initiated in the third trimester of pregnancy
| dc.contributor.author | Ochanda, Perez N | |
| dc.contributor.author | Lamorde, Mohammed | |
| dc.contributor.author | Kintu, Kenneth | |
| dc.contributor.author | Wang, Duolao | |
| dc.contributor.author | Chen, Tao | |
| dc.contributor.author | Malaba, Thokozile | |
| dc.contributor.author | Myer, Landon | |
| dc.contributor.author | Waitt, Catriona | |
| dc.contributor.author | Reynolds, Helen | |
| dc.contributor.author | Khoo, Saye | |
| dc.date.accessioned | 2022-09-06T12:38:32Z | |
| dc.date.available | 2022-09-06T12:38:32Z | |
| dc.date.issued | 2022-06-07 | |
| dc.date.updated | 2022-06-12T03:22:38Z | |
| dc.description.abstract | Introduction Evidence on health-related quality of life (HRQoL) outcomes is limited for new antiretroviral therapies (ART). Dolutegravir-based treatment is being rolled out as the preferred first-line treatment for HIV in many low- and middle-income countries. We compared HRQoL between treatment-naïve pregnant women randomized to dolutegravir- or efavirenz-based ART in a clinical trial in Uganda and South Africa. Methods We gathered HRQoL data from 203 pregnant women of mean age 28 years, randomized to either dolutegravir- or efavirenz-based ART. We used the medical outcomes study-HIV health survey at baseline, 24 and 48 weeks between years 2018 and 2019. Physical health summary (PHS) and mental health summary (MHS) scores were the primary study outcomes, while the 11 MOS-HIV subscales were secondary outcomes. We applied mixed model analysis to estimate differences within and between-treatment groups. Multivariate regression analysis was included to identify associations between primary outcomes and selected variables. Results At 24 weeks postpartum, HRQoL scores increased from baseline in both treatment arms: PHS (10.40, 95% CI 9.24, 11.55) and MHS (9.23, 95% CI 7.35, 11.10) for dolutegravir-based ART; PHS (10.24, 95% CI 9.10, 11.38) and MHS (7.54, 95% CI 5.66, 9.42) for efavirenz-based ART. Increased scores for all secondary outcomes were significant at p < 0.0001. At 48 weeks, improvements remained significant for primary outcomes within group comparison. Estimated difference in PHS were higher in the dolutegravir-based arm, while increases in MHS were more for women in the efavirenz-based armat 24 and 48 weeks. No significant differences were noted for corresponding PHS scores at these time points compared between groups. Differences between arms were observed in two secondary outcomes: role function (1.11, 95% CI 0.08, 2.13), p = 0.034 and physical function outcomes (2.97, 95% CI 1.20, 4.73), p = 0.001. In the multivariate analysis, internet access was associated with higher PHS scores while owning a bank account, using the internet and longer treatment duration were associated with an increase in MHS scores. Conclusion We found no important differences in HRQoL outcomes among HIV-positive women started on dolutegravir relative to efavirenz in late pregnancy. Increases in HRQoL in the first year after delivery provide additional support for the initiation of ART in HIV-positive women presenting late in pregnancy. Trial Registration Clinical Trial Number: NCT03249181 | en_US |
| dc.identifier.apacitation | Ochanda, P. N., Lamorde, M., Kintu, K., Wang, D., Chen, T., Malaba, T., ... Khoo, S. (2022). A randomized comparison of health-related quality of life outcomes of dolutegravir versus efavirenz-based antiretroviral treatment initiated in the third trimester of pregnancy. <i>AIDS Research and Therapy</i>, 19(1), 24. http://hdl.handle.net/11427/36799 | en_ZA |
| dc.identifier.chicagocitation | Ochanda, Perez N, Mohammed Lamorde, Kenneth Kintu, Duolao Wang, Tao Chen, Thokozile Malaba, Landon Myer, Catriona Waitt, Helen Reynolds, and Saye Khoo "A randomized comparison of health-related quality of life outcomes of dolutegravir versus efavirenz-based antiretroviral treatment initiated in the third trimester of pregnancy." <i>AIDS Research and Therapy</i> 19, 1. (2022): 24. http://hdl.handle.net/11427/36799 | en_ZA |
| dc.identifier.citation | AIDS Research and Therapy. 2022 Jun 07;19(1):24 | |
| dc.identifier.ris | TY - Journal Article AU - Ochanda, Perez N AU - Lamorde, Mohammed AU - Kintu, Kenneth AU - Wang, Duolao AU - Chen, Tao AU - Malaba, Thokozile AU - Myer, Landon AU - Waitt, Catriona AU - Reynolds, Helen AU - Khoo, Saye AB - Introduction Evidence on health-related quality of life (HRQoL) outcomes is limited for new antiretroviral therapies (ART). Dolutegravir-based treatment is being rolled out as the preferred first-line treatment for HIV in many low- and middle-income countries. We compared HRQoL between treatment-naïve pregnant women randomized to dolutegravir- or efavirenz-based ART in a clinical trial in Uganda and South Africa. Methods We gathered HRQoL data from 203 pregnant women of mean age 28 years, randomized to either dolutegravir- or efavirenz-based ART. We used the medical outcomes study-HIV health survey at baseline, 24 and 48 weeks between years 2018 and 2019. Physical health summary (PHS) and mental health summary (MHS) scores were the primary study outcomes, while the 11 MOS-HIV subscales were secondary outcomes. We applied mixed model analysis to estimate differences within and between-treatment groups. Multivariate regression analysis was included to identify associations between primary outcomes and selected variables. Results At 24 weeks postpartum, HRQoL scores increased from baseline in both treatment arms: PHS (10.40, 95% CI 9.24, 11.55) and MHS (9.23, 95% CI 7.35, 11.10) for dolutegravir-based ART; PHS (10.24, 95% CI 9.10, 11.38) and MHS (7.54, 95% CI 5.66, 9.42) for efavirenz-based ART. Increased scores for all secondary outcomes were significant at p < 0.0001. At 48 weeks, improvements remained significant for primary outcomes within group comparison. Estimated difference in PHS were higher in the dolutegravir-based arm, while increases in MHS were more for women in the efavirenz-based armat 24 and 48 weeks. No significant differences were noted for corresponding PHS scores at these time points compared between groups. Differences between arms were observed in two secondary outcomes: role function (1.11, 95% CI 0.08, 2.13), p = 0.034 and physical function outcomes (2.97, 95% CI 1.20, 4.73), p = 0.001. In the multivariate analysis, internet access was associated with higher PHS scores while owning a bank account, using the internet and longer treatment duration were associated with an increase in MHS scores. Conclusion We found no important differences in HRQoL outcomes among HIV-positive women started on dolutegravir relative to efavirenz in late pregnancy. Increases in HRQoL in the first year after delivery provide additional support for the initiation of ART in HIV-positive women presenting late in pregnancy. Trial Registration Clinical Trial Number: NCT03249181 DA - 2022-06-07 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - AIDS Research and Therapy KW - HRQoL KW - Dolutegravir KW - Pregnancy KW - Women KW - HIV KW - ART LK - https://open.uct.ac.za PY - 2022 T1 - A randomized comparison of health-related quality of life outcomes of dolutegravir versus efavirenz-based antiretroviral treatment initiated in the third trimester of pregnancy TI - A randomized comparison of health-related quality of life outcomes of dolutegravir versus efavirenz-based antiretroviral treatment initiated in the third trimester of pregnancy UR - http://hdl.handle.net/11427/36799 ER - | en_ZA |
| dc.identifier.uri | https://doi.org/10.1186/s12981-022-00446-3 | |
| dc.identifier.uri | http://hdl.handle.net/11427/36799 | |
| dc.identifier.vancouvercitation | Ochanda PN, Lamorde M, Kintu K, Wang D, Chen T, Malaba T, et al. A randomized comparison of health-related quality of life outcomes of dolutegravir versus efavirenz-based antiretroviral treatment initiated in the third trimester of pregnancy. AIDS Research and Therapy. 2022;19(1):24. http://hdl.handle.net/11427/36799. | en_ZA |
| dc.language.iso | en | en_US |
| dc.language.rfc3066 | en | |
| dc.publisher.department | Department of Public Health and Family Medicine | en_US |
| dc.publisher.faculty | Faculty of Health Sciences | en_US |
| dc.rights.holder | The Author(s) | |
| dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | en_US |
| dc.source | AIDS Research and Therapy | en_US |
| dc.source.journalissue | 1 | en_US |
| dc.source.journalvolume | 19 | en_US |
| dc.source.pagination | 24 | en_US |
| dc.subject | HRQoL | en_US |
| dc.subject | Dolutegravir | en_US |
| dc.subject | Pregnancy | en_US |
| dc.subject | Women | en_US |
| dc.subject | HIV | en_US |
| dc.subject | ART | en_US |
| dc.title | A randomized comparison of health-related quality of life outcomes of dolutegravir versus efavirenz-based antiretroviral treatment initiated in the third trimester of pregnancy | en_US |
| dc.type | Journal Article | en_US |