Seven-year efficacy of a lopinavir/ritonavir-based regimen in antiretroviral-naïve HIV-1-infected patients.
OBJECTIVE
Evaluate efficacy and tolerability of lopinavir/ritonavir (LPV/r) plus stavudine and lamivudine long term in antiretroviral-naïve patients.


METHODS
Open-label follow-up of prospective, randomized, multicenter trial.


METHODS
Antiretroviral-naïve HIV-infected subjects (N = 00) received of 3 doses of LPV/r plus stavudine and lamivudine for 48 weeks then received LPV/r soft-gel capsules 400/00 mg plus stavudine and lamivudine. After 6 years, subjects replaced stavudine with tenofovir.


RESULTS
At 7 years, by intent-to-treat analysis, 61 % had plasma HIV-RNA <400 copies/mL and 59% had < 50 copies/mL. Thirty-nine subjects discontinued treatment due to adverse events (n = 6), personal/other reasons (0), loss to follow-up (9), and noncompliance (4). Among 28 subjects qualifying for drug resistance testing, no protease inhibitor or stavudine resistance was observed and 4 showed lamivudine resistance. Most common drug-related moderate or severe adverse events were diarrhea (28%), nausea (6%), and abdominal pain (11 %). Subjects who received stavudine (median 6.6 years) and switched to tenofovir demonstrated significant improvements in total cholesterol (p = .009), triglycerides (p = .023), apolipoprotein C-III (p < .001 ), adiponectin (p = .008), fasting insulin (p = .04), and leptin (p = .03).


CONCLUSIONS
LPV/r-based therapy demonstrated sustained efficacy with no protease inhibitor or stavudine resistance through 7 years in antiretroviral-naïve patients. Switching from stavudine to tenofovir resulted in significant improvements in multiple metabolic parameters.
Murphy
Robert L
RL
Northwestern University, Chicago, Illinois, USA.
da Silva
Barbara A
BA
Hicks
Charles B
CB
Eron
Joseph J
JJ
Gulick
Roy M
RM
Thompson
Melanie A
MA
McMillan
Florence
F
King
Martin S
MS
Hanna
George J
GJ
Brun
Scott C
SC
D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D024882:Drug Resistance, Viral; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D019259:Lamivudine / Q000009:adverse effects / Q000627:therapeutic use*; D061466:Lopinavir; D008297:Male; D008875:Middle Aged; D011744:Pyrimidinones / Q000009:adverse effects / Q000627:therapeutic use*; D019438:Ritonavir / Q000009:adverse effects / Q000627:therapeutic use; D018119:Stavudine / Q000009:adverse effects / Q000627:therapeutic use*
D019380:Anti-HIV Agents; D011744:Pyrimidinones; D061466:Lopinavir; D019259:Lamivudine; D018119:Stavudine; D019438:Ritonavir