Document Detail


Second-line treatment in the Malawi antiretroviral programme: high early mortality, but good outcomes in survivors, despite extensive drug resistance at baseline.
MedLine Citation:
PMID:  20345885     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: The Malawi antiretroviral therapy (ART) programme uses the public health approach to identify ART failure. Advanced disease progression may occur before switching to second-line ART. We report outcomes for patients evaluated and initiated on second-line treatment in Malawi.
METHODS: Patients meeting Malawi immunological or clinical criteria for ART failure in two large urban ART clinics were evaluated for virological failure (viral load >400 HIV-1 RNA copies/mL) and, if failure was confirmed, initiated on second-line ART (zidovudine/lamivudine/tenofovir/lopinavir/ritonavir). Patients were seen monthly and laboratory evaluations were performed quarterly and as needed. We performed logistic regression modelling to identify factors associated with mortality, mortality or new HIV illnesses, and virological suppression at 12 months.
RESULTS: Of the 109 patients with confirmed virological failure, five patients died prior to initiation, three declined switching and 101 patients initiated second-line treatment. Over 12 months, 10 additional patients died, 34 patients experienced 45 HIV-related events, and 19 patients experienced grade 3 or 4 toxicities. Among survivors, 85.2% had HIV-1 RNA<400 copies/mL at 12 months. While power to distinguish differences was limited, response rates were similar regardless of baseline resistance level. The median CD4 count increase was 142 cells/microL. World Health Organization clinical failure at baseline [odds ratio (OR) 3.47; 95% confidence interval (CI) 1.14-10.59] and body mass index <18.5 (OR 4.43; 95% CI 1.15-17.12) were risk factors for death. Baseline CD4 count <50 cells/microL was associated with increased risk for death or morbidity at 12 months (OR 2.57; 95% CI 1.01-6.52).
CONCLUSIONS: Second-line treatment in Malawi was associated with substantial mortality, morbidity and toxicity but, among survivors, virological outcomes were favourable.
Authors:
M C Hosseinipour; J J Kumwenda; R Weigel; L B Brown; D Mzinganjira; B Mhango; J J Eron; S Phiri; J J van Oosterhout
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Publication Detail:
Type:  Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2010-03-19
Journal Detail:
Title:  HIV medicine     Volume:  11     ISSN:  1468-1293     ISO Abbreviation:  HIV Med.     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-08-10     Completed Date:  2011-01-05     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100897392     Medline TA:  HIV Med     Country:  England    
Other Details:
Languages:  eng     Pagination:  510-8     Citation Subset:  IM    
Affiliation:
University of North Carolina Project, Lilongwe, Malawi. mina_hosseinipour@med.unc.edu
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MeSH Terms
Descriptor/Qualifier:
Adenine / adverse effects,  analogs & derivatives
Adolescent
Adult
Anti-Retroviral Agents / adverse effects,  therapeutic use*
Body Mass Index
CD4 Lymphocyte Count
Developing Countries
Drug Resistance, Viral*
Drug Therapy, Combination / methods
Drug Toxicity / chemically induced,  epidemiology*
Female
Genotype
HIV Infections / drug therapy*,  etiology,  mortality
HIV-1 / genetics*
Humans
Malawi / epidemiology
Male
Medication Adherence
Middle Aged
National Health Programs
Phosphonic Acids / adverse effects
Prospective Studies
RNA, Viral / analysis*
Statistics as Topic
Treatment Failure
Tuberculosis / complications
Urban Population
Viral Load
Zidovudine / adverse effects
Chemical
Reg. No./Substance:
0/Anti-Retroviral Agents; 0/Phosphonic Acids; 0/RNA, Viral; 107021-12-5/tenofovir; 30516-87-1/Zidovudine; 73-24-5/Adenine

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