De-simplifying single-tablet antiretroviral treatments for cost savings in France: From the patient perspectives to a 6-month follow-up on generics

Abstract

In developed countries, most people living with HIV/AIDS are treated with costly brand single-tablet regimens. Given the economic impact, French guidelines recommend using generic antiretroviral therapy when possible to decrease antiretroviral therapy costs. We aimed to study HIV-infected patients' acceptability to switch from a brand single-tablet regimens [abacavir/lamivudine/dolutegravir (Triumeq ®) or emtricitabine/tenofovir disoproxil fumarate/rilpivirine (Eviplera ®)] to a treatment comprising of two pills: one is a fixed-dose generic combination of 2 Nucleoside Analogs and the second tablet is the third antiretroviral. This study was a prospective observational study in a French hospital. During their followup, patients on stable single-tablet regimens were made aware of the possible cost-saving. They were questioned about their willingness and barriers accepting the substitution. Participants chose between the two regimens, either to remain on single-tablet regimens or switch to the de-simplified regimen. Six months later, a second survey was given to the patient who chose to de-simplify and HIV viral load was controlled. The study included 98 patients: 60 receiving emtricitabine/tenofovir disoproxil fumarate/rilpivirine (Eviplera ®) and 38 on abacavir/lamivudine/dolutegravir (Triumeq ®). Forty-five patients accepted the de-simplified treatment, 37 refused and 16 were undecided and followed the decision offered by their physician. The main reason for unwillingness to switch is the number of pills (77.3%). In multivariate model analysis, male patients (p = 0.001) who have taken antiretroviral therapy for over 20 years (p = 0.04) and who retrieve their treatment in their community hospital (p = 0.03) are more likely to accept the switch. Fifty-one patients accepted to replace their singletablet regimens and six months later, the majority was satisfied; only four returned to singletablet regimens because of suspected side effects. Half of the people living with HIV/AIDS in our cohort accepted to switch from brand single-tablet regimens to a two-tablet regimen containing generic drugs within a process that emphasizes health expenditure savings.

Adverse drug reactions attributed to generic substitution of antiretroviral medications among HIV treatment and pre-exposure prophylaxis clients in British Columbia, Canada

“…The subset analysed for the primary outcome of generic PSI ADRs in the first-year-post-rollout included 5339 HIV-Tx and 8095 PrEP clients. Across all product versions, HIV-Tx clients were 83% male sex and median (Q1-Q3), age 52 (43-58) years, while PrEP clients were 99% male sex, age 33 (27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42) years (Table 1).…”

“…Several single-clinic studies describe safe and effective de-simplification of single tablet ARV regimens to an equivalent multi-tablet combination including a generic NRTI product. [32][33][34] In Alberta, Canada, 19/257 (7.4%) clients who voluntarily initiated or switched to generic abacavir-lamivudine plus dolutegravir subsequently switched to the brand-name, single tablet equivalent after median 255 days (8.5 months) follow-up. In 2/257, (0.8%) a generic-related ADR was noted as the reason for change (one gastrointestinal upset, one allergic reaction).…”

The effect of number of pills and dosing frequency on antiretroviral drug adherence: An assessment using two adherence monitoring measures

“…This claim is buttressed by findings of Cantundo et al [18] whose study reported that patients on concomitant medications to address other health conditions asides HIV infection are prone to non-adherence to antiretroviral drugs. Furthermore, some researchers demonstrated that though the simplification of ARVs has helped in improving adherence, not all patients benefit from it as its effect can be counterbalanced by the effect on non-antiretroviral drugs taken by HIV positive individuals [19,20].…”

The transformation of HIV therapy: One pill once a day

“…De-simplifying STRs to two or three tablets once-daily regimens for cost savings was attempted in Calgary, Canada [35], France [36], and Denmark [37]. In these health care systems which emphasize health expenditure savings and societal altruism, de-simplification was accepted by ∼ 50% of patients approached in the Canadian and French study with preference for STR cited for those declining de-simplification.…”