Virological, Immunological, and Clinical Impact of Switching from Protease Inhibitors to Nevirapine or to Efavirenz in Patients with Human Immunodeficiency Virus Infection and Long-Lasting Viral Suppression

Abstract

Seventy-seven subjects infected with human immunodeficiency virus were randomized to switch from protease inhibitor (PI) therapy to nevirapine therapy (group A; n=26) or to efavirenz therapy (group B; n=25) or to continue PI therapy (group C; n=26). At month 12, viral suppression had been maintained in 96% of patients in group A, 92% of patients in group B, and 92% of patients in group C. A significant increase in the CD4(+) level was observed in all 3 groups. In group A, lipid profiles improved, whereas levels of gamma-glutamiltransferase and alanine aminotransferase significantly increased; 1 subject interrupted treatment because of hepatotoxicity. In group B, an increase in gamma-glutamiltransferase levels was also observed, and 3 patients interrupted treatment because of central nervous system symptoms. Two patients in group C withdrew therapy. Quality of life significantly improved for groups A and B. In patients receiving effective PI-based therapy, the replacement of the PI with either nevirapine or efavirenz is safe and virologically effective.

Evaluation of nevirapine‐switch strategies for HIV treatment

“…Furthermore, the CD4 count is consistently observed to increase (overall range approximately 50-150 cells/mL) and does not differ among NVP, EFV and ABC switch regimens [13][14][15].…”

“…These studies were all conducted in economically developed countries, mainly in Europe (the UK, Spain, Italy and France), with one each in the USA and Australia. Seven publications reporting results from randomized switch protocols were reviewed in great detail and are discussed comprehensively [10][11][12][13][14][15][16][17]. Two major retrospective cohort studies are considered [18][19][20].…”

“…A high rate of virological suppression maintenance was achieved in those switched to NVP after a minimum of 9 months of PI-based highly active antiretroviral therapy (HAART) despite the fact that 75% of this cohort had received nonsuppressive therapy [i.e. dual nucleoside reverse transcriptase inhibitor (NRTI) therapy] before HAART [14]. The effect of selection bias influences interpretation of these results, as a history of a demonstrated ability to take antiretroviral therapy predicts future treatment success.…”

“…Quality of life Quality of life may be improved in those switching to NVP-based therapy from PI treatment [11,14,16]. Ruiz et al reported that 70% of those with improved quality of life scores 48 weeks post-switch cited reduced pill burden and side-effect profile as the primary cause [10].…”

Simplification of Antiretroviral Therapy (ART)

“…Another study compared the change of PI to EFV (n = 25), NVP (n = 26) or continue with the PI (n = 26), in patients on ART with PI, CD4> 300 cells / microL and CVP <80 copies / mL maintained over 9 months. At 48 weeks (ITT) there was no difference in the proportion of patients with undetectable VL with EFV (80%) or IP (77%) 16 . In a combined study design (case-control and randomized), we compared outcomes of 167 patients (who after discontinuation of IP were randomized to EFV or ABC), with another 167 patients who continued with IP (control).…”