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CD4 response, lipid changes and liver outcome in 506 patients receiving nevirapine-based regimens for a median of 9 years

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Journal of the International AIDS Society201013(Suppl 4):P81

https://doi.org/10.1186/1758-2652-13-S4-P81

Published: 8 November 2010

Keywords

  • Liver Function Test
  • General Health Status
  • Lipid Lowering Therapy
  • Alkaline Phosphatase Level
  • Favourable Change

Purpose of the study

To evaluate long-term outcomes in pts maintaining a NVP-based regimen

Methods

Retrospective cohort study. Pts received a NVP regimen for at least 5 years and continued up to present. Demographic, clinical, and analytical variables were recorded. A sample size of 506 pts was randomly selected from participating cohorts

Summary of results

Median follow up 8.9 (5.7-11.3) years (506 pts followed ≥6 years and 270 ≥ 9 years). At baseline: 74% men, 47 years old, 36% drug users, 40% AIDS, 40% HCV+, 14% alcohol. 45% detectable VL, CD4 395/uL, 19% CD4 < 200/uL, 27% ALT Grade 1-2, 36% AST grade 1-2. 30% ART naïve. 84% received NVP+2 nucleosides (NRTI) during the study period, 17% PI.

Most frequent current combinations were NVP+TDF/FTC in 31%, +ABC/3TC in 24% and +ZDV/3TC in 22%. 97% reached undetectable VL. In pts receiving 2 NRTI+NVP (n=423), regardless of being HCV+ or -, a significant increase was observed in general health status markers: hemoglobin, platelets and albumin (all p<0.001), and +218 and +322 CD4 cells increase after 6 and 9 years (p<0.001). Triglyceride levels decreased 19% and total cholesterol 4% in pretreated pts vs 9% and 12% increase in naive pts. After 6 years, the proportion of pts with lipid levels above (below in HDL) the NCEP thresholds for recommending lipid lowering therapy was 50% for TC, 43% TG, 34% LDL and 14% HDL.

Regarding liver outcomes in the 506 pts, a significant decrease in ALT and AST levels were found in naive (p=0.02, p<0.001) and HCV+ pts (p=0.065, p<0.001), while a strong decrease in alkaline phosphatase (AP) levels (up to -44%) was observed in naive and pretreated pts as well as in HCV+ or — (all p<0.001), regardless of TDF use. GGT levels increased by 78% regardless of the patient status (p<0.001).

This favourable changes in liver function tests occurred despite 53% of 89 pts in whom biopsy or fibroscan was performed after a median of 7.1 years of NVP therapy, fibrosis (≥ F2 and/or 7≥kPa) was detected. In addition, as a consequence of transaminase and platelet changes, Fib-4 index significantly decreased in ARV naive HIV/HCV pts at 9 years (p=0.01)

Conclusions

Patients receiving a long-term NVP-including regimen, show a progressive improvement in general health status and CD4 response, an acceptable lipid profile and favourable changes in liver function tests, even in those with HCV+. The marked decrease in AP levels shown in this large cohort of NVP-treated pts merits further study.

Authors’ Affiliations

(1)
Hospital Universitari de Bellvitge, HIV Unit, Barcelona, Spain
(2)
Hospital Universitari de Bellvitge, Edificio Antigua Escuela de Enfermeria 3° planta, Barcelona, Spain
(3)
Hospital Clinic de Barcelona, Barcelona, Spain
(4)
Hospital Universitario de Canarias, Tenerife, Spain
(5)
Hospital Alcalá de Henares, Madrid, Spain
(6)
Hospital Universitario de La Coruña, La Coruña, Spain
(7)
Hospital de Valdecilla, Santander, Spain
(8)
Hospital Virgen del Rocio, Sevilla, Spain
(9)
Hospital Gregorio Marañón, Madrid, Spain
(10)
Hospital Ramón y Cajal, Madrid, Spain
(11)
Hospital Arnau de Vilanova, Lleida, Spain
(12)
Hospital Vall d´Hebron, Barcelona, Spain
(13)
Hospital Son Dureta, Palma de Mallorca, Spain
(14)
Hospital Dr. Negrin, Las Palmas, Spain
(15)
Hospital Santa M° del Rosell, Murcia, Spain
(16)
Hospital La Fe, Valencia, Spain
(17)
Hospital de Mataró, Mataró, Spain
(18)
Hospital de la Princesa, Madrid, Spain

Copyright

© Podzamczer et al; licensee BioMed Central Ltd. 2010

This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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