Effectiveness and tolerability of dolutegravir and abacavir/lamivudine administered as two separate pills compared to their equivalent single‐tablet regimen in a multicentre cohort in Spain

Abstract

Introduction: We aimed to assess the effectiveness and tolerability of dolutegravir (DTG), abacavir (ABC) and lamivudine (3TC) administered as branded STR (DTG/ABC/3TC) or as two separate pills (DTG and either branded ABC/3TC [DTG+(ABC/3TC)b] or generic ABC/3TC [DTG+(ABC/3TC)g]). Methods: We included individuals from the multicentre cohort of the Spanish HIV/AIDS Research Network (CoRIS) who received DTG/ABC/3TC, DTG+(ABC/3TC)b or DTG+(ABC/3TC)g during 2015 to 2018. We used multivariable logistic regression to compare the proportion of antiretroviral-na€ ıve individuals who achieved viral suppression (VS) (viral load ≤50 copies/ mL) at 24 weeks of initiating with DTG+(ABC/3TC)b or DTG+(ABC/3TC)g versus DTG/ABC/3TC. We also calculated the proportion of virologically suppressed individuals who maintained VS at 24 weeks after switching from DTG/ABC/3TC to DTG+(ABC/3TC)g. Results: During the study period, 829, 68 and 47 treatment-na€ ıve individuals started treatment with DTG/ABC/3TC, DTG+(ABC/3TC)b or DTG+(ABC/3TC)g respectively. The proportions of individuals who changed their regimens due to side effects during the first 24 weeks were 3.7%, 4.4% and 6.4% respectively (p = 0.646). We did not find significant differences in VS at 24 weeks among individuals starting with DTG+(ABC/3TC)b or DTG+(ABC/3TC)g compared to those initiating with DTG/ABC/3TC. Among 177 virologically suppressed individuals who switched from DTG/ABC/3TC to DTG+(ABC/3TC)g, 170 (96.0%) maintained VS at 24 weeks. Conclusions: In na€ ıve individuals, the effectiveness and tolerability at 24 weeks of DTG plus ABC/3TC administered as two separate pills, either as branded or generic ABC/3TC, was similar to the STR DTG/ABC/3TC. Switching the STR DTG/ABC/ 3TC to its separate components DTG+(ABC/3TC)g in virologically suppressed individuals did not seem to impair its effectiveness.

Prescriptions of generic antiretroviral drugs in three healthcare centers in the Paris area, France

“…The relatively low rate of generic prescriptions (30.2%) in our study could be first explained because of the two levels of legal protection in France: intellectual property protection of the patent, which protects commercial exploitation for a period of 20 years, and administrative protection, as any drug is protected for a period of 8 years from the date of the first marketing authorization, thus favoring branded STR prescriptions. The second explanation could be the unwillingness of French medical doctors to de-simplify a branded STR regimen, which has been shown to be accepted by half of the people [9–11], with similar virologic outcomes to branded STR [12–14]. In 2015, a French study showed that up to 26% of prescribers favored de-simplifying STR to promote generic drugs [15].…”

Negative impact of a health insurer-mandated de-simplification from a single-tablet regimen to a two-tablet regimen

“…Since late 2017, the introduction of generic forms of frequently used tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) and abacavir/lamivudine (ABC/3TC) [1] has enabled healthcare providers to prescribe medications that are equally effective but at a much lower cost [6]. Several studies have shown that desimplifying an STR into a two-tablet regimen (TTR) containing the same antiretroviral agents induces serious cost reductions [7][8][9][10][11].…”