Switching d4T to tenofovir and protease inhibitor to efavirenz

15 May 2005. Related: Conference reports, Paediatric care, CROI 12 (Retrovirus) 2005.

Alessandra Viganò and colleagues reported findings from a study to assess the strategy of replacing protease inhibitor (PI) by efavirenz (EFV) and stavudine (d4T) by tenofovir (TDF) in HIV-positive children with long-lasting viral suppression.

In this study, 27 HIV-positive children (age range 5.0 to 17.5 years) with viral load < 50 copies/mL for the last 48 weeks, on HAART containing lamivudine (3TC) + d4T+ 1 PI were randomised either to switch d4T to TDF and PI to EFV at baseline (n = 14; group A) or at week 24 (n = 13; group B).

All children maintained 3TC and were followed with clinical assessment, viral load, CD4 count, fasting metabolic, and renal parameters for 48 weeks.

The authors reported from baseline to week 24 and at week 48, both groups had unchanged CD4 count 884, 759, 848 vs 809, 795, 754 cells/mm3; HIV RNA < 50 copies/mL; unchanged and normal levels of serum creatinine, phosphate, calculated creatinine clearance; absence of proteinuria and glycosuria.

The children in Group A, from baseline to week 24, showed a significant decrease on total cholesterol (–20%, p< 0.03), triglycerides (–35%, p< 0.05) and total cholesterol/HDL ratio from 3.5 to 3.0, p< 0.006); and at week 48, the authors reported stable cholesterol levels and a further decrease of triglycerides and HDL cholesterol. Children in this group with elevated (> 95th percentile for age and sex) cholesterol and triglyceride levels showed a marked decrease of both over the study period (from 43 to 0% and from 36 to 7%, respectively).

In Group B, from baseline to week 24, the children showed unchanged cholesterol, triglycerides, HDL cholesterol and percentage of HIV with elevated cholesterol and triglyceride levels; at week 48, the authors reported a significant decrease of cholesterol (–14%; p < 0.03), triglycerides (–41%; p < 0.05), and HDL cholesterol (from 3.9 to 3.2; p < 0.006). The children with elevated cholesterol and triglyceride levels showed marked reduction of both after the initiation of the new regimen (from 46 to 8% and from 54 to 0%, respectively).

No adverse events were reported throughout this study.

The authors concluded: “The replacement of PI by EFV and d4T by TDF in HIV-infected children who had been receiving a HAART regimen containing 3TC+d4T+PI who had long lasting viral suppression provides continued virological suppression, stable CD4 response.

References:

1. Verweel G, van der Lee M, Burger D et al. 6-Month follow-up of once-daily lopinavir/ritonavir in HIV-1-infected children. 12th CROI Boston 2005 Abstract 769.
2. Chadwick EG, Rodman J, Palumbo P et al. A prospective evaluation of pharmacologic, virologic, and immunologic parameters of lopinavir/ritonavir for HIV-1-infected infants < 6 months of age. 12th CROI, Boston 2005. Abstract 766.
3. Kiser J, Rutstein R, Aldrovandi G et al. Pharmacokinetics of atazanavir/ritonavir in HIV-infected infants, children, and adolescents: PACTG 1020A. 12th CROI, Boston 2005. Abstract 767.
4. Viganò A, V Giacomet V, Beretta S et al. Switching stavudine to tenofovir and protease inhibitor to efavirenz results in a favourable clinical outcome in HIV-infected children. 12th CROI, Boston 2005. Abstract 770.