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 ≥18 years old having received DTG as part of their combined antiretroviral therapy (cART) between April 1, 2014 and December 1, 2017. Primary endpoint: rate of virologic suppression, defined as plasma HIV-1 viral load (VL) < 50 copies/mL, at weeks 24, 48, and 96. Secondary endpoints: (i) durability, expressed as probability of experiencing loss of virologic suppression by week 96 (defined as 2 consecutive HIV-1 VL measurements of ≥200 copies/mL after having initially achieved virologic suppression), (ii) immunological response at weeks 24, 48, and 96, (iii) incidence of and reasons for DTG discontinuation, and (iv) change in weight at week 96.
RESULTS: 4,101 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 (NP) 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 -1.0 - 5.0).
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.