Background: To assess the impact on virological outcomes of a switch from branded single-tablet regimen (STR) including tenofovir, efavirenz, and emtricitabine (STR-TEE) to generic triple-tablet regimen (TTR), including tenofovir, efavirenz, and lamivudine (TTR-TEL), which was implemented on April 1, 2011 to obtain economic savings.
Methods and Findings: From the Capital Region of Denmark (covering two-thirds of the Danish HIV patients), we included combination antiretroviral therapy (cART)–naive patients who administered STR-TEE from April 1, 2010 to March 31, 2011 (n = 111) or TTR-TEL from April 1, 2011 to March 31, 2012 (n = 56) and cART-experienced HIV patients who were on STR-TEE from April 1, 2010 (n = 356) or were switched from STR-TEE to TTR-TEL after April 1, 2011 (n = 512). We estimated the fraction with detectable HIV-RNA, development of the 184V/I resistance mutations, and time to switch of cART. Approximately 96.2% of cART-experienced patients on STR-TEE were shifted to TTR-TEL after April 1, 2011. For the naive STR-TEE and TTR-TEL patients, the fractions with detectable HIV-RNA at week 48 were 7.0% and 8.3% and for the cART experienced 4.0% and 4.4%, respectively. The 184V/I resistance mutation was detected in 1 cART-experienced patient on TTR-TEL with virological failure. The risk of switch to a new cART regimen was slightly increased in the cART-experienced population (difference in 1-year risk: 1.5%; 95% confidence interval: −2.4% to 5.4%).
Conclusions: In settings comparable with the Danish health care system, the estimated economic savings from a switch from STR-TEE to TTR-TEL can be realized with negligible short-term risk of adverse outcomes.
*Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Denmark;
†Department of Microbiology Diagnostics and Virology, Statens Serum Institut, Copenhagen, Denmark;
‡Department of Infectious Diseases, Copenhagen University Hospital, Nordsjælland Hospital, Denmark; and
§Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Denmark.
Correspondence to: Frederik Neess Engsig, MD, Department of Infectious Diseases, Rigshospitalet, Blegdamsvej 9, DK2100 Copenhagen, Denmark (e-mail: email@example.com).
N.O. has received research funding from Roche, Bristol-Myers Squibb, Merck Sharp & Dohme, GlaxoSmithKline, Abbott, Boehringer Ingelheim, Janssen-Cilag, and Swedish Orphan. F.N.E. has received research funding from Merck Sharp & Dohme. J.G. has received research funding from Abbott, Roche, Bristol-Myers Squibb, Merck Sharp & Dohme, Pharmasia, GlaxoSmithKline, Swedish Orphan, and Boehringer Ingelheim.
Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.jaids.com).
F.N.E. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. F.N.E., J.G., M.H., and N.O. contributed to design. F.N.E., J.G., M.H., L.N.N., G.K., L.R.M., and N.O. contributed to acquisition of data. F.N.E., J.G., M.H., and N.O. contributed to analysis and interpretation of data. F.N.E., J.G., and N.O. drafted the article. F.N.E., J.G., M.H., L.N.N., G.K., L.R.M., and N.O. revised the manuscript critically for important intellectual content. F.N.E., J.G., M.H., L.N.N., G.K., L.R.M., and N.O. approved the final manuscript.
Received November 11, 2013
Accepted April 09, 2014