Toxicity and clinical outcomes in patients with HIV on zidovudine and tenofovir based regimens: a retrospective cohort study

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 HIVpositive 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 (p¼0.63) 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.

Adverse effects of chronic treatment with the Main subclasses of highly active antiretroviral therapy: a systematic review

“…A total of 21 articles were included in this study: 10 observational cohort studies , six clinical trials , two cross‐sectional studies , one experimental study , one observational prospective study and one case report .…”

Challenges associated with the treatment of Buruli ulcer

“…Patients may therefore require periodic blood transfusion corresponding to clinical symptomatic state, but this is not without risks ranging from transfusion reactions and risk of other infections . The incidence of severe anemia in BU/HIV coinfection may also require that a first choice drug namely Zidovudine be replaced with Tenofovir as per protocol in most Sub‐Saharan regions . Tenofovir however is not readily stocked at most antiretroviral therapy (ART) centers at the sub‐districts and may pose serious treatment challenges .…”

“…The incidence of severe anemia in BU/HIV coinfection may also require that a first choice drug namely Zidovudine be replaced with Tenofovir as per protocol in most Sub‐Saharan regions . Tenofovir however is not readily stocked at most antiretroviral therapy (ART) centers at the sub‐districts and may pose serious treatment challenges . In terms of effectiveness of drug therapy in BU/HIV coinfected cases, there are concerns about interaction between one of the first option ARTs (Nevirapine) and the antimycobacteria drug rifampicin, where it has been noted that the drug concentration of Nevirapine tends to decrease with such interactions …”

A Prospective Study of Adverse Drug Reactions to Antiretroviral Therapy in a Tertiary Care Hospital at Allahabad, Uttar Pradesh

“…A median delay of 5.5 days from the detection of HIV status to initiation of A.R.T was seen among the participants. A study by Thuppal et al 15 showed a median delay of 36 days with TDF regimen and 116 days with AZT based regimens. Incidence of ADRs accounted to 4.4 per person year and incidence of ADR reporting individuals to 123 per 100 person years.…”