ABSTRACT
Introduction: in many settings, several factors including adverse drug reactions and clinical failure can limit treatment choices for combined antiretroviral therapy (cART). The aim of the study was to describe the incidence of first-line cART changes and associated factors in a cohort of Kenyan sex workers.Methods: this was a retrospective review of medical records collected from 2009 to 2013. The review included records of HIV-infected patients aged ⥠18 years, who received either stavudine or zidovudine or tenofovir disoproxil fumarate-based regimens. Using systematic random sampling, the study selected 1 500 records and censoring targeted the first incident of a drug change from the first-line cART.Results: the overall incidence rate of cART changes was 11.1 per 100 person-years within a total follow-up period of 3 427.9 person-years. Out of 380 patients who changed cART, 370 (97%) had a drug substitution and 10 (3%) switched regimens. The most commonly cited reasons for changing cART were adverse drug reactions (76%). Tenofovir disoproxil fumarate had a lower drug change rate (1.9 per 100 person years) compared to stavudine (27 per 100 person years). Using zidovudine as the reference group, stavudine-based regimens were significantly associated with an increased hazard of drug changes (adjusted hazards ratio 10.2; 95% CI: 6.02-17.2).Conclusion: these findings suggest a moderate incidence of cART changes among sex workers in Nairobi, Kenya. Individuals using stavudine were at a higher risk of experiencing a change in their cART, mostly presenting within 20 months, and primarily due to adverse drug reactions
Subject(s)
Antiretroviral Therapy, Highly Active , HIV Infections , Incidence , Kenya , StavudineABSTRACT
Background: The incidence of antiretroviral therapy (ART)-induced lactic acidosis and its associated mortality may be reduced by appropriate dosing; risk stratification and early detection. Objectives: To describe the epidemiology of lactic acidosis; define the risk factors and identify predictive laboratory markers in the context of the roll-out of ART in South Africa. Design: A nested case control study. Risk factor analysis was adjusted for the established risk factors of weight and gender.Setting and subjects: Persons commenced on stavudine-containing therapy between 2004 and 2007 at Port Shepstone Hospital in KwaZulu-Natal were included. Persons with a body weight above 60 kg received Stavudine 40 mg twice daily; and those with a body weight below 60 kg; 30 mg twice daily.Outcome measures: Assessed risk factors included weight; gender; age; alanine transaminase (ALT); urea; creatinine; albumin; cholesterol; triglyceride (TG) levels; CD4 counts and viral loads.Results: Lactic acidosis occurred in 79 (17 per 1 000 person-years) of 1 762 people living with HIV on ART. Significant factors were being female [adjusted odds ratio (AOR) of 5.4] and increased body weight (adjusted OR of 1.1 per kg). The risk of lactic acidosis increased 6.6; 6.9 and 95 times (adjusted ORs) as weight increased from a baseline weight of 60 kg to 60-69 kg; 70-79 kg or 80 kg; respectively. Six months into therapy; predictors of developing lactic acidosis were an ALT 50 IU/l (adjusted OR of 11.1) and a higher TG (adjusted OR of 8.8 per mmol/l). No associations were found with regard to age; CD4 count; viral load; and creatinine or albumin levels.Conclusion: Obese females are at greatest risk of lactic acidosis; with an exponential increase in risk above 80 kg. The 30-mg dose may be preferable; given that a sharp increase in risk occurred at 60 kg; was most likely dose related; and that 30 mg has been shown to provide adequate virological suppression. Additional risk factors for lactic acidosis include a high ALT and TG levels at treatment
Subject(s)
Acidosis , Anti-Retroviral Agents/toxicity , Biomarkers , Risk Factors , StavudineABSTRACT
Objectifs: Evaluer la prevalence des neuropathies peripheriques et leurs facteurs associes. Methode: Il s'agit d'une etude transversale menee du 1er fevrier au 1er juillet 2011 sur l'ensemble des patients recevant un traitement antiretroviral associant deux inhibiteurs nucleosidiques et un inhibiteur non nucleosidique de la reverse transcriptase. Le diagnostic des neuropathies peripheriques a ete pose sur la base de criteres cliniques. Les facteurs associes etaient representes par l'existence de facteurs de risque connu comme cause de neuropathies peripheriques. La numeration des lymphocytes T CD4 a ete effectuee chez tous les patients.Resultats : L'etude a porte sur 512 personnes. Parmi eux; 157 (30;7) presentaient des neuropathies peripheriques a type de paresthesies (75;2); les sensations de brulure (44;6); les douleurs franches (42;7). L'age avance; l'alcoolisme; l'immunodepression avancee et l'exposition a la stavudine etaient les facteurs. Conclusion : L'incrimination de la Stavudine dans la survenue de cette maladie justifie son retrait des protocoles ARV de premiere ligne
Subject(s)
Academic Medical Centers , Peripheral Nervous System Diseases , Prevalence , StavudineABSTRACT
Background: The number of antiretroviral drugs (ARVs) available to HIV/AIDS patients in Tanzania is increasing due to a number of intervention programs such as PEPFAR and the Clinton Foundation. These ARVs are imported from a number of countries. However; currently there are no reports on the quality of these medicines imported into Tanzania.The sale of substandard and counterfeit drugs has been well documented particularly in developing countries. The marketing of counterfeit and substandard antiretroviral drugs has also been widely reported in Africa. It is therefore important to closely monitor the quality of ARVs marketed in Tanzania to ensure that substandard or fake products are uncovered before great harm is done to public health.Objective: To assess the quality of ARVs marketed in Tanzania.Methodology: A total of five samples of two generic drugs (stavudine and indinavir) from different manufacturers were randomly collected from various retail pharmacies.Assessment of package inserts and labels was carried out using the Tanzania Food and Drugs Authority (TFDA) specifications. The capsules were analyzed for the content of the active components using validated in-house methodsResults: All samples of Indinavir and Stavudine investigated conformed to the packaging and labeling specifications. However; all Indinavir samples were found to contain excess amount of active ingredient (112.6- 118) compared to the official limit of 95 - 105. One sample of stavudine capsules failed the dissolution test; releasing only 56instead of the specified 80of the active ingredient. Conclusion: The results of this study emphasize the need for careful monitoring of the quality of drugs to ensure their safety and efficacy