Antiretroviral Treatment Outcomes Among Late HIV Presenters Initiating Treatment With Integrase Inhibitors or Protease Inhibitors

G Schuettfort; L Boekenkamp; A Cabello; AG Cotter; P De Leuw; J Doctor; M Górgolas; L Hamzah; E Herrmann; G Kann; P Khaykin; PW Mallon; A Mena; M Del Palacio Tamarit; CA Sabin; C Stephan; T Wolf; AE Haberl


HIV Medicine. 2021;22(1):47-53. 

In This Article


We conducted a retrospective, multicentre analysis including people diagnosed with HIV infection with a CD4 cell count < 200 cells/μL and/or an AIDS-defining condition who started ART at one of five European HIV treatment centres based in Frankfurt (Germany), Madrid (Spain) and London (England). All individuals were aged > 18 years, diagnosed as HIV positive with a CD4 cell count < 200 cells/μL and/or an AIDS-defining condition, and started ART for the first time from 1st of January 2014 to 31st of December 2016; those starting ART regimens including either an INI or a PI were included in this study. The start date of 1st of January 2014 was chosen because this was the date of the approval of dolutegravir (DTG) in the European Union.

The primary study endpoints were discontinuation of ART at or before 16 and 52 weeks after starting ART; these time-points were chosen to correspond to standard endpoint times in RCTs of 12 and 48 weeks, whilst allowing some flexibility around this to reflect the observational nature of the study and nonstandardized appointment times.

Secondary endpoints were mortality, reasons for any treatment discontinuations or switches (relating to the primary endpoints), change in CD4 cell count (%) at weeks 12 and 48, number (%) of patients with HIV RNA < 50 copies/mL at weeks 12 and 48, adverse events reported by 12 and 48 weeks and number of within the recruitment period newly diagnosed category B or C diagnosis. Virological response was assessed using the Food & Drug Administration (FDA) snapshot analysis at 12 and 48 weeks. For each of the above endpoints, a window period of 4 weeks around each time-point was considered to again allow for nonstandardized appointment times.

Adverse events were categorized as gastrointestinal intolerability, jaundice, renal stones, pancreatitis, nausea, diarrhoea, renal insufficiency, anaemia, fatigue, myalgia, vertigo, vomiting, dizziness, hepatitis, alopecia, joint pain, pruritus, rash, abnormal dreams, insomnia and proteinuria.

Data were pseudo-anonymized and national data sharing policies were followed. Ethical approval for the study was obtained for each participating site.

Statistical differences between the groups receiving an INI- or a PI-based regimen were assessed using Mann–Whitney tests, χ 2 tests or Fisher's exact test, as appropriate, and two-tailed tests were performed.

The study protocols were reviewed and approved by the Ethics Committee of the University Hospital Frankfurt, Germany (Approval No. 270/09). All human research procedures were in accordance with the standards set forth in the Declaration of Helsinki principles of 1975, as revised in 2013 ( All study participants provided written informed consent at admission to clinical care including consent for future analysis of their data. The study conforms to the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines.