Sowmyanarayanan V Thuppal1, Christine A Wanke2, Farzad Noubary3, Joshua T Cohen4, Mkaya Mwamburi5, Abraham C Ooriapdickal6, Jayaprakash Muliyil7, Gagandeep Kang7, George M Varghese6, Priscilla Rupali6, Rajiv Karthik6, Rajkumar Sathasivam6, Peace Clarance6, Susanne A Pulimood8, Dincy Peter8, Leni George8. 1. Department of Public Health and Community Medicine, Nutrition/Infection Unit, Tufts University School of Medicine, Boston, MA 02111, USA Department of Medicine, Unit-1 and ID, Christian Medical College, Vellore, TN 632004, India tvsowmy@gmail.com Sowmyanarayanan.thuppal@tufts.edu. 2. Department of Public Health and Community Medicine, Nutrition/Infection Unit, Tufts University School of Medicine, Boston, MA 02111, USA. 3. Institute for Clinical Research and Health Policy Studies, Research Design Center/Biostatistics Research Center, Tufts University School of Medicine, Boston, MA 02111, USA. 4. Institute for Clinical Research and Health Policy Studies, Center for the Evaluation of Value and Risk in Health, Tufts University School of Medicine, Boston, MA 02111, USA. 5. Department of Public Health and Community Medicine, Nutrition/Infection Unit, Tufts University School of Medicine, Boston, MA 02111, USA Department of Medicine, Unit-1 and ID, Christian Medical College, Vellore, TN 632004, India. 6. Department of Medicine, Unit-1 and ID, Christian Medical College, Vellore, TN 632004, India. 7. Department of Gastrointestinal Sciences, Christian Medical College, Vellore, TN 632004, India. 8. Department of Dermatology, Christian Medical College, Vellore, TN 632004, India.
Abstract
BACKGROUND: Adverse drug reactions are a major concern with zidovudine/stavudine treatment regimens. The less toxic tenofovir regimen is an alternative, but is seldom considered due to the higher costs. This study compared adverse drug reactions and other clinical outcomes resulting from the use of these two treatment regimens in India. METHODS: Baseline, clinical characteristics and follow-up outcomes were collected by chart reviews of HIV-positive adults and compared using univariate/multivariate analysis, with and without propensity score adjustments. RESULTS: Data were collected from 129 and 92 patients on zidovudine (with lamivudine and nevirapine) and tenofovir (with emtricitabine and efavirenz) regimens, respectively. Compared to patients receiving the zidovudine regimen, patients receiving the tenofovir regimen had fewer adverse drug reactions (47%, 61/129 vs 11%, 10/92; p<0.01), requiring fewer regimen changes (36%, 47/129 vs 3%, 3/92; p0.01). With the propensity score, the zidovudine regimen had 8 times more adverse drug reactions (p<0.01). Opportunistic infections were similar between regimens without propensity score, while the zidovudine regimen had 1.2 times (p=0.63) more opportunistic infections with propensity score. Patients on the tenofovir regimen gained more weight. Increase in CD4 levels and treatment adherence (>95%) was similar across regimens. CONCLUSIONS: Patients on a tenofovir regimen have better clinical outcomes and improved general health than patients on the zidovudine regimen.
BACKGROUND: Adverse drug reactions are a major concern with zidovudine/stavudine treatment regimens. The less toxic tenofovir regimen is an alternative, but is seldom considered due to the higher costs. This study compared adverse drug reactions and other clinical outcomes resulting from the use of these two treatment regimens in India. METHODS: Baseline, clinical characteristics and follow-up outcomes were collected by chart reviews of HIV-positive adults and compared using univariate/multivariate analysis, with and without propensity score adjustments. RESULTS: Data were collected from 129 and 92 patients on zidovudine (with lamivudine and nevirapine) and tenofovir (with emtricitabine and efavirenz) regimens, respectively. Compared to patients receiving the zidovudine regimen, patients receiving the tenofovir regimen had fewer adverse drug reactions (47%, 61/129 vs 11%, 10/92; p<0.01), requiring fewer regimen changes (36%, 47/129 vs 3%, 3/92; p0.01). With the propensity score, the zidovudine regimen had 8 times more adverse drug reactions (p<0.01). Opportunistic infections were similar between regimens without propensity score, while the zidovudine regimen had 1.2 times (p=0.63) more opportunistic infections with propensity score. Patients on the tenofovir regimen gained more weight. Increase in CD4 levels and treatment adherence (>95%) was similar across regimens. CONCLUSIONS:Patients on a tenofovir regimen have better clinical outcomes and improved general health than patients on the zidovudine regimen.
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Authors: Thomas B Campbell; Laura M Smeaton; N Kumarasamy; Timothy Flanigan; Karin L Klingman; Cynthia Firnhaber; Beatriz Grinsztejn; Mina C Hosseinipour; Johnstone Kumwenda; Umesh Lalloo; Cynthia Riviere; Jorge Sanchez; Marineide Melo; Khuanchai Supparatpinyo; Srikanth Tripathy; Ana I Martinez; Apsara Nair; Ann Walawander; Laura Moran; Yun Chen; Wendy Snowden; James F Rooney; Jonathan Uy; Robert T Schooley; Victor De Gruttola; James Gita Hakim Journal: PLoS Med Date: 2012-08-14 Impact factor: 11.069