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


A total of 218 individuals were included in the study: 13.8% were women and 25.7% were of non-European ethnicity. The median baseline CD4 cell count was 91 cells/μL [interquartile range (IQR) 40, 91 cells/μL] and the median CD4:CD8 ratio was 0.17 (IQR 0.12, 0.20). In total, 131 (60.1%) commenced an INI-based regimen, of whom 82 (62.6%) started DTG, 34 (26.0%) raltegravir (RAL) and 15 (11.5%) elvitegravir (EVG). Of the 87 (39.9%) commencing a PI-based regimen, 54 (62.1%) started darunavir (DRV), 28 (32.2%) atazanavir (ATV) and 8 (5.8%) lopinavir (LPV), all of which were boosted with ritonavir. The backbone nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) included in the regimens were tenofovir disoproxil/emtricitabine [TDF/FTC; 171 (78.7%)], abacavir/lamivudine [ABC/3TC; 42 (19.0%)] and zidovudine/lamivudine [ZDV/3TC; five (2.3%)]. Those commenced on PI-based regimens were older (median 42 years vs. 44.9 years for those on INIs). The mean HIV viral load was 5.8 (IQR 4.6, 7.0) log10 copies/mL and just over half [121 (55.5%)] of participants had presented with an AIDS-defining condition at HIV diagnosis. Baseline characteristics are presented in Table 1.

There was no significant difference in the proportion of patients discontinuing ART by week 12 between those receiving an INI- and those receiving a PI-based regimen [17.7% vs. 16.1%, respectively; 96% confidence interval (CI) 0.59, 2.00; P = 0.76]. The most frequent documented reasons for discontinuation by week 12 were changes in the NRTI backbone (73.9% vs. 35.7%, respectively), including minor modifications to fixed-dose regimens [e.g. the replacement of TDF with tenofovir alafenamide (TAF)], followed by side effects, with no significant differences between the regimens. Reasons for discontinuations are presented in Table 2. Similarly, no significant difference in discontinuation proportions was observed at week 48 between the groups (39.3% vs. 44.0%, respectively; P = 0.52). Twelve (28.5%) of those receiving an INI-based regimen experienced a change in the NRTI backbone compared to only four (12.1%) of those receiving a PI-based regimen. Other reasons for discontinuation/switch of the first-line regimen by week 48 are presented in Table 2.

Virological failure was reported in four patients on INI-based regimens and in two patients on PI-based regimens at week 48.

By week 12, there was a significant difference between those receiving INI- and PI-based regimens in terms of the proportions with an HIV RNA ≤ 50 copies/mL (63.5% vs. 42.9%, respectively; P = 0.009), although this was not sustained at week 48 (86.1% vs. 81.1%, respectively; P = 0.36).

The median CD4 cell count after 48 weeks was 360 (IQR 243, 461) cells/μL in those receiving an INI-based regimen and 315 (234, 461) cells/μL in those receiving a PI-based regimen (P = 0.41). There were no significant differences in the clinical outcomes reported between the two groups. There was no difference between the number of patients within the recruitment period newly diagnosed with centers for disease control and prevention (CDC) category B or C infection (P = 0.17 and 0.52, respectively). Mortality at week 48 was 2.3% (three patients) in those receiving INI-based regimens and 3.4% (three patients) in those receiving PI-based regimens. The causes of death for those receiving INI-based regimens were progressive multifocal leukoencephalopathy and one non-AIDS-defining cause of death, and for those receiving PI-based regimens, Pneumocystis jirovecii pneumonia (PJP)/Kaposi's sarcoma, Pneumocystis carinii pneumonia (PCP)/Kaposi's sarcoma/cytomegalovirus infection and Kaposi's sarcoma/primary effusion lymphoma. The most frequently reported adverse event within the observation period was gastrointestinal intolerance, with 10.6% and 12.6% of those in the two groups reporting this event, respectively. Less frequently reported events were nausea (3.0% vs. 5.7%, respectively), pruritus (3.0% vs. 1.1%, respectively), joint pain (3.0% vs. 1.1%, respectively) and sleep disorders (0.7% vs. 2.3%, respectively). Clinical outcomes at week 48 are presented in Table 3.