Real World Data on Forgiveness to Uncomplete Adherence to Bictegravir/ Emtricitabine/Tenofovir Alafenamide

Abstract

Background: forgiveness is the ability of a given regimen to maintain complete viral suppression despite a documented imperfect adherence. We explored forgiveness of bictegravir/emtricitabine/tenofovir alafenamide. Methods: drug refills were used to calculate the percent day covered (PDC) as a proxy of adherence. Forgiveness was calculated as the achieved rate of a selected HIV-RNA threshold by a given level of imperfect adherence. Results: 281 adult PLWH were followed for 343 patient/years. Adherence was very high with a median of 98% (IQR 95-100%). A PDC as low as 70% was sufficient to obtain 100% and maintain virologic suppression. According to probit analysis adherence was not related to the possibility to maintain an HIV-RNA TND or < 50 copies/ml. Conclusions: Long-term success of ART needs effective regimens that are the least intrusive of the patient's lifestyle, an elevated forgiveness may be considered as an additional feature that can further improve long-term outcomes.

Favorable Virological Outcome, Characteristics of Injection Site Reactions, Decrease in Renal Function Biomarkers in Asian People with HIV Receiving Long-Acting Cabotegravir Plus Rilpivirine

“…In Italian real-world data, about 40% of B/F/TAF users had undetectable HIV-RNA, and those with HIV-RNA less than detection sensitivity were able to maintain undetectable HIV-RNA if their estimated adherence level was about 70% or higher. 19 Because CAB plus RPV was introduced by switching to PWH with stably suppressed HIV-RNA, in this study, the proportion of PWH with undetectable HIV-RNA at baseline was ∼80%, but this proportion was maintained over 1 year, as was treatment with oral antiretroviral drugs. 19 …”

“… 19 Because CAB plus RPV was introduced by switching to PWH with stably suppressed HIV-RNA, in this study, the proportion of PWH with undetectable HIV-RNA at baseline was ∼80%, but this proportion was maintained over 1 year, as was treatment with oral antiretroviral drugs. 19 …”

Predicting Factors of Plasma HIV RNA Undetectability after Switching to Co-Formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Experienced HIV-1 Patients: A Multicenter Study

“…Interestingly, at T24, undetectable plasma HIV RNA frequency was comparable in PLWH with plasma HIV RNA < 50 copies/mL and with undetectable HIV RNA at T0. Although it is important to interpret these findings in the context of the study’s small size, this result suggests that the high forgiveness of the drug combination [ 35 ] and/or a bictegravir human plasma unbound fraction (able to cross cell membranes and act on pharmacological sanctuaries), which can reach 6.7% [ 36 ], may have an impact on the long-term virological response.…”

A cautionary note on entry and exit strategies with long-acting cabotegravir and rilpivirine

“…It must be emphasized that resistance to CAB leads to a substantial reduction in future treatment options because of the extensive cross resistance within the key class of integrase inhibitors [14]. Although 80-85% adherence to modern oral high genetic barrier regimens may be sufficient to achieve or maintain virological suppression [15][16][17], some PWH, who perfectly qualified for LA CAB-RPVas per current indications, failed virologically despite 100% adherence to the injection schedule. Notably, extensive analysis of the pooled data from key clinical trials failed to identify any single predictor of failure [18].…”