Efficacy and safety of the switch of Triumeq^® to generic (abacavir + lamivudine) + Tivicay^®: data at 48 weeks

Abstract

Background: Generic drugs may help to support antiretroviral treatment. We want to assess the efficacy and safety at 24 weeks of the change of coformulated (abacavir + lamivudine + dolutegravir) to (abacavir + lamivudine) coformulated as a generic pharmaceutical specialty + dolutegravir. Methods: Between February and June 2017, switch from Triumeq® to a generic pharmaceutical specialty co-formulated tablet (abacavir + lamivudine) plus Tivicay® was made. Demographic, viroimmunological characteristics and the Charlson index were collected. Six months after switching, efficacy and safety were evaluated. Results: Switch was made in 93 patients, with a mean age of 47 years, after six months there were five patients (5.4%) with viral loads between 50 and 400 copies, no patient had viral loads of greater amount. There were 2 interruptions due to toxicity (2.15%), in relation to symptoms of the central nervous system. There were no differences in the amount of years with HAART, nor in the previous months with the STR regimen based on abacavir + lamivudine + dolutegravir, nor in the Charlson index. The effective saving in 2017 derived from the change in these 93 patients was € 125.512. Conclusions: The change from a regimen of abacavir + lamivudine + dolutegravir seems to be safe and effective at 24 weeks.

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].…”