Background Adverse drug reactions are a major concern with zidovudine/stavudine treatment

Background Adverse drug reactions are a major concern with zidovudine/stavudine treatment regimens. p<0.01) requiring fewer regimen changes (36% 47 vs 3% 3 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. Keywords: Adverse drug reaction Clinical outcome HIV Propensity score analysis Tenofovir Zidovudine Introduction In 2012 the adult HIV prevalence in India was 0.27% with approximately 2 million people infected with HIV.1 Free anti-retroviral therapy (ART) has been provided to eligible patients through the government sponsored ART centers since 2005 and by December 2013 approximately one-third of patients living with HIV were covered under the program.2 The Rapamycin Rapamycin (Sirolimus) (Sirolimus) combination ART commonly used to initiate therapy is composed of a non-nucleoside reverse transcriptase inhibitor with a two nucleoside reverse transcriptase inhibitor backbone. At the Rapamycin (Sirolimus) initiation of combination ART zidovudine or stavudine were the first-line nucleoside reverse transcriptase inhibitor choices for inclusion in the backbone.3 However adverse drug reactions (ADRs) are a major concern in patients receiving these drug therapies and approximately one-quarter of patients on treatment containing these regimens experience ADRs.4-7 These findings led WHO to recommend tenofovir-containing regimens as the preferred first-line treatment of choice.8 In resource-limited settings however stavudine/zidovudine regimens are often still used due Rabbit Polyclonal to GPRIN2. to the higher costs of the tenofovir-containing regimens. Studies in resource-sufficient settings have demonstrated greater efficacy with Rapamycin (Sirolimus) tenofovir-containing regimens compared to non-tenofovir-containing regimens.9-12 There are very few studies from resource-limited settings that have compared tenofovir-containing regimens with other ART treatment modalities. A South African study has demonstrated that tenofovir-containing regimens are associated with fewer toxicity related switches and lower proportions of loss-from-care compared to zidovudine-containing regimens.13 While a Cochrane review comparing zidovudine- and tenofovir-containing regimens showed Rapamycin (Sirolimus) that ADR and virologic responses were similar between these regimens tenofovir-containing regimens were superior to zidovudine-containing regimen in terms of immunological response and adherence.14 Another study from Lesotho demonstrated that toxicity-related treatment change was two times greater among patients on zidovudine-containing regimen than among patients on tenofovir-containing regimen.15 A multicenter randomized trial showed that a tenofovir-containing regimen had higher efficacy and better safety outcomes than zidovudine-containing regimen.16 In India efforts are being made to shift to a tenofovir-containing regimen as the preferred first line therapy for patients with HIV under the free government ART program. To better understand the impact of a tenofovir-containing regimen in India we examined differences in several clinical outcomes including ADRs opportunistic infections CD4 count BMI weight and morbidity in patients receiving either the zidovudine- or tenofovir-containing regimens at a single private hospital clinic. Materials and methods Study population The study population consisted of all adult ART na?ve patients with a confirmed diagnosis of HIV infection with a CD4 value <200 cells/μl who attended and initiated treatment at the Infectious Disease clinic at the Christian Medical College Vellore India between January 2001 and June 2008. The free roll-out of government sponsored ART was initiated at this center in August 2008. Until that time.