title: Safety, efficacy, and tolerability of nelfinavir-containing antiretroviral therapy for patients coinfected with HIV and hepatitis C undergoing methadone maintenance.
abstract: The safety, efficacy, and tolerability of nelfinavir (NFV)-containing antiretroviral therapy were evaluated in patients coinfected with HIV and hepatitis C undergoing methadone maintenance at an urban outpatient opioid treatment program serving a minority adult population. Eligibility covered methadone-maintained patients coinfected with HIV and hepatitis C who had received or were currently receiving NFV. The yield was 51 case patients. Parameters examined looked into safety, efficacy, and tolerability. Nelfinavir was discontinued in 2 patients for liver function abnormalities but resumed in 1 patient. One patient developed laboratory abnormalities during NFV therapy that were not present before NFV therapy; in 12 case patients, pre-NFV therapy liver function abnormalities resolved completely during NFV therapy. There was a statistically significant increase in CD4 count during NFV therapy. Viral load decreased or was unchanged in 10 case patients and increased in 8, of whom 5 had a CD4 count increase during NFV therapy. Three patients had diarrhea and 4 patients had constipation. Nelfinavir was not discontinued -- neither was dose adjusted -- in any of these patients. Patients who had received NFV > or =36 months had a smaller increase in mean methadone dose as compared with patients who had received NFV <36 months. The results show that NFV is safe, efficacious, and well tolerated.
authors.affiliation: Division of Medical Services, Evaluation and Research, Addiction Research and Treatment Corporation, Brooklyn, NY 11201, USA.
authors.forename: Lawrence S
authors.initials: LS
authors.lastname: Brown
authors.forename: Steven
authors.initials: S
authors.lastname: Kritz
authors.forename: Melissa
authors.initials: M
authors.lastname: Chu
authors.forename: Charles
authors.initials: C
authors.lastname: Madray
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D006526:Hepatitis C / Q000150:complications*; D006801:Humans; D008297:Male; D008691:Methadone / Q000008:administration & dosage*; D008875:Middle Aged; D019888:Nelfinavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D009293:Opioid-Related Disorders / Q000150:complications / Q000534:rehabilitation*; D012189:Retrospective Studies
chemical_list: D019380:Anti-HIV Agents; D019888:Nelfinavir; D008691:Methadone