High acceptability and viral suppression of patients on Dolutegravir-based first-line regimens in pilot sites in Uganda: A mixed-methods prospective cohort study

Abstract

Uganda adopted the integrase inhibitor dolutegravir (DTG) as part its preferred first-line HIV treatment regimen in 2018. Prior to the national rollout, the Uganda Ministry of Health and Clinton Health Access Initiative (CHAI) launched a pilot study in July 2017 aimed at better understanding patients' and prescribers' experience and acceptability of DTG. Patients were enrolled in the study if they were newly initiating treatment or switched from an NNRTI regimen due to intolerance. Patients were followed up for 6 months after initiation onto DTG and acceptability and experiences were assessed through questionnaires at one-month and six-month follow-up visits. In addition to acceptability side effects of patients on DTG regimens were assessed. Analysis was conducted using MS Excel and SAS 9.4 and confidence intervals were adjusted for facility level clustering. A total of 365 patients from 6 study sites were enrolled in the study, of whom 50% were treatment-experienced and 50% treatment naïve. 325 patients completed the 6 months of follow-up. Survey results showed a high level of acceptability (more than 90%) of DTG-containing regimens for both categories of patients during the from one-month and six-months interviews. The rate of self-reported side effects amongst patients was 33% overall and higher for experienced (37%) than naïve (29%) patients at 6 months. Although frequencies declined between month-1 and month-6, the changes were not statistically significant. Almost all patients (94%) were virally suppressed at 6 months. Overall, the study findings showed a very high level of acceptability of Dolutegravir-based regimens across both experienced and naïve patients. The overall viral suppression rate in this cohort was 94% at six months of taking DTG-based regimen.

Virological Suppression and Its Associated Factors of Dolutegravir Based Regimen in a Resource-Limited Setting: An Observational Retrospective Study in Ethiopia

“…This percentage of viral suppression was in line with the study done in Uganda which showed a high virologic suppression with 94% of patients maintaining virologic suppression. 18 Since there is limited evidence in resource limited settings, it is difficult to compare the result with other studies. This study revealed that there is a better virological suppression after the initiation of dolutegravir based regimen than pre-dolutegravir based regimen initiation ( Z scores = −4.825; p- value <0.001), with a small effect size (r =0.18).…”

Provider perspectives on the acceptability and tolerability of dolutegravir-based anti-retroviral therapy after national roll-out in Uganda: a qualitative study

“…More specifically, we found that it was common for patients to take DTG-based medication during night time contrary to explicit instructions from clinicians to take the tablet in the morning. A study by Nabitaka and colleagues [ 44 ] found that trouble sleeping was the third most prevalent self-reported side effect by patients who had been on DTG for at least 6 months. Previous studies have reported insomnia as an ADR associated with DTG [ 45 – 47 ], however our study shades more light on this phenomenon by suggesting that patient adherence to clinician instructions on when to take DTG-based ART is an attribute of interest.…”

“…This calls for programming interventions aimed at improving adherence to medication instructions with regard to DTG-based regimens. Furthermore, our findings point to the need for increased sensitizations of patients prior to enrolling them on newer HIV medications [ 44 , 48 ]. For instance, patients were used to a routine of taking efavirenz-based regimens at night.…”

Patient-Reported Treatment Satisfaction and Quality of Life Among People Living with HIV Following the Introduction of Dolutegravir-Based ART Regimens in Ukraine

“…An observational study following DTG scale-up in Brazil found higher rates of ART adherence with daily dosing, DTG-based regimen (DTG + TDF/3TC), in routine practice [38]. Similarly, a prospective observational cohort study of DTG use in Uganda found that 97% of new ART patients and 92% of existing ART patients on DTG reported after 6 months that they would recommend the treatment to a friend, and 93% of existing ART patients who switched to DTG indicated they preferred it over their prior regimen [39]. Despite the evidence of favorable treatment satisfaction with DTG, our study in Ukraine showed modest but not statistically significant evidence of lower ART adherence among new and existing ART patients on DTG-based regimens.…”