Published online Jul 26, 2019. doi: 10.12998/wjcc.v7.i14.1814
Peer-review started: March 15, 2019
First decision: April 18, 2019
Revised: May 2, 2019
Accepted: May 23, 2019
Article in press: May 23, 2019
Published online: July 26, 2019
Processing time: 136 Days and 13.7 Hours
United States and European human immunodeficiency virus (HIV) treatment guidelines consider regimen simplification to fixed dose coformulations (FDCs) to improve adherence to antiretroviral therapy. However, the US Department of Health and Human Services states that there is limited data to support or refute the superiority of FDCs versus multi-tablet regimens (MTRs). With the constant increase in the number of patients in highly active antiretroviral therapy (HAART), innovative measures are increasingly needed to contain costs while maintaining the highest quality of care.
HAART is provided free of charge to all HIV positive residents in Italy. As FDCs are often more expensive in comparison to the same drugs administered separately in a MTR, we considered a cost-effective strategy involving patients in the switch from their FDCs to corresponding MTRs including generic antiretrovirals.
We conducted a prospective study among a cohort of adults with suppressed HIV-1 viremia who accepted to switch from FDCs to corresponding MTRs in order to verify if this would affect the virological and immunological response in comparison to maintaining the FDC regimens.
From January 2012 to December 2013, we assessed the eligibility of all the HIV-1 positive adults on stable HAART being treated at our hospital-based outpatient clinic in Treviso, Italy. Participants who accepted to switch from their FDC regimen to the corresponding MTR joined the MTR group, while those who maintained a FDC regimen joined the FDC group. Clinical data, including changes in HAART regimens, respective reasons why and adverse effects, were recorded at baseline and at follow-up visits occurring at weeks 24, 48 and 96. All participants were assessed for virological and immunological responses at baseline and at weeks 24, 48 and 96.
Two hundred and forty-three eligible HIV-1 adults on HAART were enrolled: 163 (67%) accepted to switch to a MTR, joining the MTR group, while 80 (33%) maintained their FDCs, joining the FDC group. In a parallel analysis, there were no significant differences in linear trend of distribution of HIV-RNA levels between the two groups and there were no significant odds in favour of a higher level of HIV-RNA in either group at any follow-up and on the overall three strata analysis. In a before-after analysis, both FDC and MTR groups presented no significant differences in distribution of HIV-RNA levels at either weeks 48 vs 24 and weeks 96 vs 24 cross tabulations. A steady increase of mean CD4 count was observed in the MTR group only, while in the FDC group we observed a slight decrease (-23 cells per mmc) between weeks 24 and 48.
Involving patients in the switch from their FDC regimens to the corresponding MTRs for economic reasons did not affect the effectiveness of antiretroviral therapy in terms of virological response and immunological recovery. The appropriate use of generic drugs and a good doctor-patient relationship must play a key role in balancing the needs of HIV patients with those of the Health System.
With the advent of the new generic drugs in Italy (abacavir/lamivudine, tenofovir/emtricita-bine, darunavir, tenofovir, and in the near future rilpivirine), it will be of great interest to assess the effectiveness of the desimplification of Triumeq and other new FDCs to their respective generic drugs in the context of our National Health System.