Effectiveness of Dolutegravir-Based Antiretroviral Therapy in a Real-World Setting in a Belgian Cohort of 4101 HIV Patients

Rakan Nasreddine; Eric Florence; Bernard Vandercam; Michel Moutschen; Jean-Christophe Goffard; Paul De Munter; Marc Delforge; Wouter Marinus; Stéphane De Wit


AIDS. 2020;34(8):1151-1159. 

In This Article

Abstract and Introduction


Objective: To describe the treatment outcomes of patients receiving dolutegravir (DTG) in a 'real-world setting' in Belgium.

Design: Retrospective, observational, multicenter cohort.

Methods: Inclusion criteria: HIV-1 patients at least 18 years old having received DTG as part of their combined antiretroviral therapy (cART) between 1 April 2014 and 1 December 2017. Primary endpoint: rate of virologic suppression, defined as plasma HIV-1 viral load less than 50 copies/ml, at weeks 24, 48, and 96. Secondary endpoints: durability, expressed as probability of experiencing loss of virologic suppression by week 96 (defined as two consecutive HIV-1 viral load measurements of at least 200 copies/ml after having initially achieved virologic suppression); immunological response at weeks 24, 48, and 96; incidence of and reasons for DTG discontinuation; and change in weight at week 96.

Results: Four thousand, one hundred and one patients were included. Through 96 weeks, virologic suppression rate was 96% (on-treatment analysis), probability of experiencing loss of virologic suppression was 7%, and mean increase in CD4+ cell count was 100 cells/μl (SD 220). There were 785 (19.1%) discontinuations of DTG (8.9 discontinuations per 100 patient-years). The most common cause of discontinuation was an adverse drug reaction (ADR; 9.5%) with neuropsychiatric toxicity being the most prevalent (5.2%; 2.4 discontinuations per 100 patient-years). By week 96, the median change in weight for the study population was +2.0 kg (IQR -1 to 5).

Conclusion: In this large cohort, DTG showed excellent virologic efficacy and was generally well tolerated. Whether DTG results in undesirable weight gain or rather statistically significant results, remains a debate.


Current international guidelines recommend dolutegravir (DTG), a second-generation integrase strand transfer inhibitor (INSTI), in combination with other antiretrovirals as a preferred option for the management of treatment-naive and treatment-experienced HIV-1 patients.[1–4] Most of the available data concerning the use of DTG are based on controlled trials that may sometimes not reflect the everyday patient. As such, there is an increased interest for 'real-world data', gathered from heterogeneous patient populations by means of patient surveys and observational cohort studies.[5] Some 'real-world data' on DTG have been previously reported revealing some intriguing results, such as increased neuropsychiatric and gastrointestinal toxicity, and excessive weight gain.[6,7] The objective of this study is to describe the treatment outcomes in various sub-populations of patients receiving DTG in a 'real-world setting' in Belgium.