More than two million people died from HIV/AIDS in 2008 and 2.7 million were newly infected, putting the disease under the category of having a significant public health impact [2]. In low resource settings, fixed-dose combinations of nucleoside reverse transcriptase inhibitors (NRTIs) such as tenofir and lamivudine; and non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as efavirenz, are commonly used as antiretroviral therapy for HIV-infected patients in order to increase adherence to lifelong treatment.

In a phase II open-label clinical trial carried out at HIV-NAT, Thai AIDS Research Centre, Thai Red Cross from April 2010 to December 2011, the efficacy and safety of a fixed-dose combination containing 300 mg tenofovir, 300 mg lamivudine and 600 mg efavirenz was assessed.

Fifty-one treatment-naïve patients and 49 patients previously on tenofovir, lamivudine and efavirenz as separate tablets (switch arm) were enrolled in the trial. Safety profiles, including liver and renal functions, were assessed at baseline, weeks 4, 12, 24 and 48. In the switch group, mid-dose tenofir plasma concentrations were measured by high performance liquid chromatography at baseline and week 4 after a switch to single fixed-dose combination tablet.

CD4 counts and HIV viral loads fell within acceptable limits. Three serious adverse events were reported, one of which was possibly related to the study drug. Forty-nine mild to moderate efavirenz-related central nervous system events also occurred. There were no statistically significant changes in renal function and liver enzymes. Mean plasma concentrations of all three drugs in the fixed-dose combination met the acceptable target levels.

The results showed that the generic fixed-dose combination of tenofir, lamivudine and efavirenz was well tolerated and efficacious. The authors concluded that their ‘findings lend support to the use of this generic fixed-dose combination as first-line antiretroviral therapy in resource limited settings.’

Editor’s comment
If you are interested in contributing a research article in safety and efficacy of generics to GaBI Journal, please send us your submission here.

Related articles

Black-box safety warnings and the future of generic drug liability

Overview of research on ‘general’ policies aimed at generics in 2012

Reference

1.  Maek-a-Nantawat W, et al. Safety and efficacy of once-daily single generic fixed-drug combination tablet of tenofovir, lamivudine and efavirenz among HIV-infected Thais. J Int AIDS Soc. 2012;15(Suppl 4):18285.

Permission granted to reproduce for personal and educational use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.