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CD4 T Cells Decline after 48 Weeks on a Once-Daily Didanosine, Tenofovir and Nevirapine Simplification Regimen

The aim of the current study was to assess the efficacy and safety of a once-daily antiretroviral regimen in HAART-experienced subjects with long-lasting viral suppression.

One-hundred-and-sixty-nine patients with chronically suppressed viral load (limit of detection <50 copies/ml) were recruited.

Based on patient willingness to simplify treatment, 84 of them continued receiving their usual treatment (BID Group) and 85 switched to once-daily didanosine (Videx)/tenofovir (Viread)/ nevirapine (Viramune) (QD Group) in a non-randomized fashion.

Results

At week 48, the proportion of patients with viral suppression in the QD and in the BID Group, respectively, was 97 vs 100% in the per-protocol analysis (P=0.497), and 76 vs 86% for the intention-to-treat analysis (P=0.176).
Nevertheless, CD4 count decreased in the QD Group, with a mean decline of 95 cells/mm3 (95% CI: 45–145). Twelve subjects in the QD Group (14%) discontinued treatment due to adverse events, mainly nevirapine-related hepatitis (6%).
No significant differences regarding the rate of acute pancreatitis or peripheral neuropathy were observed between both groups.

A significant improvement in the lipid profile was only seen in the QD Group. High levels of adherence were observed in both groups during follow-up, as well as a good quality of life.

At week 48, a reduction in effort to take medication (P<=0.001) and an increment in the satisfaction with the treatment (P<0.001) was only seen in the QD group.

No differences were observed in median nevirapine trough levels between patients on twice-daily nevirapine at baseline (4820 ng/ml) and subjects in the QD Group (6090 ng/ml, P=0.30).

Conclusion

The authors conclude, “Treatment simplification to a once-daily antiretroviral regimen based on didanosine, tenofovir and nevirapine may be a valid approach in HIV-infected subjects with long-lasting viral suppression.”

“Combination of standard doses of didanosine and tenofovir may have contributed to the CD4 cell decline observed with this QD regimen.”

08/13/04

Reference
E Negredo and others. Safety and efficacy of once-daily didanosine, tenofovir and nevirapine as a simplification antiretroviral approach. Antiviral Therapy 9:335-342. 2004.

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One-hundred-and-sixty-nine patients with chronically suppressed viral load (limit of detection <50 copies/ml) were recruited.

Based on patient willingness to simplify treatment, 84 of them continued receiving their usual treatment (BID Group) and 85 switched to once-daily didanosine (Videx)/tenofovir (Viread)/ nevirapine (Viramune) (QD Group) in a non-randomized fashion.

Results

At week 48, the proportion of patients with viral suppression in the QD and in the BID Group, respectively, was 97 vs 100% in the per-protocol analysis (P=0.497), and 76 vs 86% for the intention-to-treat analysis (P=0.176).

No significant differences regarding the rate of acute pancreatitis or peripheral neuropathy were observed between both groups.

A significant improvement in the lipid profile was only seen in the QD Group. High levels of adherence were observed in both groups during follow-up, as well as a good quality of life.

At week 48, a reduction in effort to take medication (P<=0.001) and an increment in the satisfaction with the treatment (P<0.001) was only seen in the QD group.

No differences were observed in median nevirapine trough levels between patients on twice-daily nevirapine at baseline (4820 ng/ml) and subjects in the QD Group (6090 ng/ml, P=0.30).

Conclusion

The authors conclude, “Treatment simplification to a once-daily antiretroviral regimen based on didanosine, tenofovir and nevirapine may be a valid approach in HIV-infected subjects with long-lasting viral suppression.”

“Combination of standard doses of didanosine and tenofovir may have contributed to the CD4 cell decline observed with this QD regimen.”

Reference E Negredo and others. Safety and efficacy of once-daily didanosine, tenofovir and nevirapine as a simplification antiretroviral approach. Antiviral Therapy 9:335-342. 2004.

Reference
E Negredo and others. Safety and efficacy of once-daily didanosine, tenofovir and nevirapine as a simplification antiretroviral approach. Antiviral Therapy 9:335-342. 2004.