Anchalee Avihingsanon1, Wirach Maek-A-Nantawat2, Sivaporn Gatechompol3, Vorapot Sapsirisavat3, Wanida Thiansanguankul3, Jiratchaya Sophonphan3, Narujakorn Thammajaruk3, Sasiwimol Ubolyam3, David M Burger4, Kiat Ruxrungtham2. 1. HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS Research Centre, 104 Ratchadamri Rd, Pathumwan, Bangkok, 10330, Thailand; Division of Allergy and Immunology, Faculty of Medicine, Chulalongkorn University, Rama IV Rd, Pathumwan, Bangkok,10330, Thailand. Electronic address: anchaleea2009@gmail.com. 2. HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS Research Centre, 104 Ratchadamri Rd, Pathumwan, Bangkok, 10330, Thailand; Division of Allergy and Immunology, Faculty of Medicine, Chulalongkorn University, Rama IV Rd, Pathumwan, Bangkok,10330, Thailand. 3. HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS Research Centre, 104 Ratchadamri Rd, Pathumwan, Bangkok, 10330, Thailand. 4. Department of Pharmacy and Nijmegen Institute for Infection, Inflammation and Immunity (N4i), Radboud University Nijmegen Medical Center, Nijmegen, Postbus 9101, 6500 HB Nijmegen, The Netherlands.
Abstract
OBJECTIVE: To assess the efficacy and safety of a new single-tablet regimen (STR) of tenofovir disoproxil fumarate (TDF) 300mg, lamivudine (3TC) 300mg, and efavirenz (EFV) 600mg in HIV-infected Thai patients. METHODS: This was a prospective study performed for 144 weeks among 51 treatment-naïve patients and 49 experienced patients on separate tablets of TDF, 3TC, and EFV with HIV RNA<50 copies/ml. CD4, HIV RNA, liver and renal function, and lipid profiles were assessed at baseline, weeks 12, 24, and 48, and then every 24 weeks. RESULTS: The median baseline CD4 cell count was 512 cells/μl for treatment-experienced patients and 230 cells/μl for treatment-naïve patients. Median baseline log10 HIV-1 RNA for treatment-naïve subjects was 4.9 copies/ml. From the intention-to-treat (ITT) analysis, the proportion of subjects with HIV RNA <50 copies/ml at week 48, 96, and 144 was 95%, 94%, and 94%, respectively, for antiretroviral-experienced patients and 88%, 90%, and 80%, respectively, for antiretroviral-naïve patients. One virological failure at week 12 had primary drug resistance of K70R, T69D, V75L. Three serious adverse events occurred (tension headache, infective endocarditis, and cervical dysplasia) and another three discontinued the study drug due to EFV intolerance. CONCLUSIONS: This generic STR TDF/3TC/EFV is effective and well-tolerated. These findings lend support to the use of this generic STR as first-line antiretroviral therapy in resource-limited settings.
OBJECTIVE: To assess the efficacy and safety of a new single-tablet regimen (STR) of tenofovir disoproxil fumarate (TDF) 300mg, lamivudine (3TC) 300mg, and efavirenz (EFV) 600mg in HIV-infected Thai patients. METHODS: This was a prospective study performed for 144 weeks among 51 treatment-naïve patients and 49 experienced patients on separate tablets of TDF, 3TC, and EFV with HIV RNA<50 copies/ml. CD4, HIV RNA, liver and renal function, and lipid profiles were assessed at baseline, weeks 12, 24, and 48, and then every 24 weeks. RESULTS: The median baseline CD4 cell count was 512 cells/μl for treatment-experienced patients and 230 cells/μl for treatment-naïve patients. Median baseline log10 HIV-1 RNA for treatment-naïve subjects was 4.9 copies/ml. From the intention-to-treat (ITT) analysis, the proportion of subjects with HIV RNA <50 copies/ml at week 48, 96, and 144 was 95%, 94%, and 94%, respectively, for antiretroviral-experienced patients and 88%, 90%, and 80%, respectively, for antiretroviral-naïve patients. One virological failure at week 12 had primary drug resistance of K70R, T69D, V75L. Three serious adverse events occurred (tension headache, infective endocarditis, and cervical dysplasia) and another three discontinued the study drug due to EFV intolerance. CONCLUSIONS: This generic STR TDF/3TC/EFV is effective and well-tolerated. These findings lend support to the use of this generic STR as first-line antiretroviral therapy in resource-limited settings.