Seven-Year Efficacy of a Lopinavir/Ritonavir-Based Regimen in Antiretroviral—Naïve HIV-1-Infected Patients
| Autor: | Barbara A. da Silva, George J. Hanna, Martin S. King, Roy M. Gulick, Charles B. Hicks, Florence I. McMillan, Robert L. Murphy, Melanie A. Thompson, Scott C. Brun, Joseph J. Eron |
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| Rok vydání: | 2008 |
| Předmět: |
Adult
Male medicine.medical_specialty Anti-HIV Agents Lopinavir/ritonavir HIV Infections Pyrimidinones Pharmacology Lopinavir Antiretroviral Therapy Highly Active Internal medicine Multicenter trial Drug Resistance Viral Humans Medicine Pharmacology (medical) Ritonavir business.industry Stavudine Lamivudine Middle Aged Regimen Infectious Diseases Tolerability HIV-1 Female business medicine.drug |
| Zdroj: | HIV Clinical Trials. 9:1-10 |
| ISSN: | 1945-5771 1528-4336 |
| DOI: | 10.1310/hct0901-1 |
| Popis: | Evaluate efficacy and tolerability of lopinavir/ritonavir (LPV/r) plus stavudine and lamivudine long term in antiretroviral-naïve patients.Open-label follow-up of prospective, randomized, multicenter trial.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.At 7 years, by intent-to-treat analysis, 61 % had plasma HIV-RNA400 copies/mL and 59% had50 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).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. |
| Databáze: | OpenAIRE |
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