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Switching from zidovudine/lamivudine (ZDV/LMV) to tenofovir/emtricitabine (TDF/FTC) or abacavir/lamivudine (ABC/LMV) in HIV/HCV co-infection (COTKI study)

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Journal of the International AIDS Society200811 (Suppl 1) :P267

https://doi.org/10.1186/1758-2652-11-S1-P267

  • Published:

Keywords

  • Insulin Resistance
  • Liver Fibrosis
  • Homeostasis Model Assessment
  • Hepatic Toxicity
  • Hepatic Tolerability

Background

Patients with HIV/hepatitis C co-infection have glucose and lipids metabolism alterations. Both HAART and HCV contribute to lipids and glucose metabolic damage. HAART-related insulin resistance contributes to the liver steato/fibrosis evolution. Fewer data on metabolic and hepatic tolerability are available in HIV/HCV co-infected patients who switch from ZDV/LMV to TDF/FTC or ABC/LMV.

Methods

A total of 150 HIV/HCV co-infected subjects with HIV-RNA <50 copies/ml, on BID ZDV/LMV + atazanavir/ritonavir (ATV/rtv) >6 months were randomized 1:1:1 to continue this regimen or to switch to QD TDF/FTC+ATV/rtv or QD ABC/LMV +ATV/rtv. The primary end-point was change in insulin resistance, calculated with HOMA score (Homeostasis Model Assessment: fasting insulin UI/ml x glucose mmol/l/22.5) at 48 weeks. Secondary end-points included changes in absolute haemoglobin, AST, ALT, fasting lipids, CD4, and viral load. Liver fibrosis assessment by Fibroscan was planned at baseline and 96 weeks. Two sample t-test for between group comparison was used.

Summary of results

All 150 subjects were randomized: 49 to continue ZDV/LMV; 50 to switch to TDF/FTC; and 51 to switch to ABC/LMV. All patients were available for the 48-week analysis. Subjects were well matched for baseline characteristics and received a mean of 9 years prior ZDV/LMV. Median stiffness score was 7.9. Cirrhosis was in 13.5%. At 48 weeks, all randomized subjects maintained the same study therapy with VL <50 copies/ml. The change in median HOMA score was 0.2, -0.4 and -0.1 in ZDV/LMV, TDF/FTC and ABC/LMV, respectively (ZDV/LMV vs. TDF/FTC: p < 0.001; ZDV/LMV vs. TDF/FTC: p > 0.001; TDF/FTC vs. ABC/LMV: p = 0.06). Total cholesterol significantly decreased in subjects who switched from ZDV/LMV to TDF/FTC (-23 mg/dl; ZDV/LMV vs. TDF/FTC: p 0.005). Change in median HDL-cholesterol was -2, +2.5, +4 mg/dl in three arms, respectively (ZDV/LMV vs ABC/LMV: p > 0.001; ZDV/LMV vs. TDF/FTC: p > 0.001; TDf/FTC vs. ABC/LMV: p 0.08). T CD4 cell count increased significantly in subjects who switched from ZDV/LMV to TDF/FTC (+23 cell/mm3: p 0.01) or ABC/LMV (+87 cell/mm3: p = 0.001).

Conclusion

Switching from ZDV/LMV to TDF/FTC or ABC/LMV in HIV/HCV persons treated with ATV/rtv provides a simplified QD regimen which maintains virological control and improves both lipid and glucose parameters without increase in hepatic toxicities.

Authors’ Affiliations

(1)
Institute of Infectious and Tropical Diseases, Brescia, Italy

Copyright

© Nasta et al; licensee BioMed Central Ltd. 2008

This article is published under license to BioMed Central Ltd.

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