The WHO recommends enhanced adherence counseling (EAC) before regimen switch for HIV-positive, antiretroviral therapy (ART)-treated individuals with non-suppressed viral loads (VL). However, there is a paucity of data, especially within a clinical trial setting, on the determinants of viral suppression (VS) following EAC among those failing ART. We thus evaluated predictors of VS among adults failing ART who had undergone EAC in the VISEND clinical trial.
Our trial is a randomized 144 week open label non-inferiority study with adults failing (VL? 1000 copies/mL) ART of tenofovir disoproxil fumarate (TDF), lamivudine (3TC) plus efavirenz (EFV) or nevirapine (NVP), switched to 1) TDF,3TC,DTG or 2) tenofovir alafenamide (TAF), emtricitabine (FTC),DTG or 3) lopinavir/ritonavir (LPV/r) or atazanavir/r (ATV/r), zidovudine (ZDV),3TC. Viral loads and other biomarkers were collected at weeks 12, 24, 48, 72, 96 and 144. Adults with VL? 1000 copies/mL at each of these time points underwent EAC involving 3 sessions over a period of 3 months according to existing guidelines. We calculated proportions of individuals who achieved VS post EAC and analyzed factors (demographic and clinical) independently associated with VS post EAC. Using multivariable log regression models, associations were analyzed as crude risk ratios (CRR) and adjusted risk ratios (ARR).
The overall VS rates following EAC among individuals with virologic failure was 66%; broken down as follows: TAF,FTC,DTG (78%), TDF,3TC,DTG (71%), ZDV,3TC,ATV/r (62%), and ZDV,3TC,LPV/r (53%). Compared to adults with no formal education, those having primary (ARR 1.55 [1.32–1.81], P<0.001) or secondary level education (ARR 1.93 [1.65 – 2.27], P<0.001) were more likely to achieve VS. Those less likely to suppress post EAC were individuals on ART for > 5 years (ARR 0.75 [ 0.75–0.75], P<0.001), VL > 10,000 copies/mL at time of failure (0.48 [0.48 – 0.48], P<0.001), presence of comorbidities (ARR 0.77 [0.66 – 0.90], P=0.001) and those taking concomitant medications (ARR 0.67 [0.58-0.79], P<0.001). Having suffered from COVID-19 infection had no association with VS post EAC (ARR 0.59 [0.22–1.58], P=0.30). Consistent results are in Table 1.
In the VISEND trial, EAC led to VS rates near the WHO target of 70% with disparities in outcomes according to gender, education, and other factors. There is a need to routinely incorporate EAC into clinical trials and practice before regimen switch in order to maximize outcomes.