ABSTRACT
PURPOSE: We previously reported a beneficial effect of benfluorex (BFL) on oral glucose tolerance test (OGTT) and visceral fat mass in an open-label study conducted in 60 HIV-infected patients. The objective of this study was to assess whether administration of BFL compared to placebo (PBO) improves insulin resistance (IR) in HIV+ patients with HAART- induced lipodystrophy. METHOD: 22 HIV-infected patients with IR or impaired glucose tolerance were double-blind randomly assigned to receive BFL 3 tablets/day or PBO for 24 weeks. Efficacy assessments included OGTT, abdominal computed tomography, and the measurement of fasting lipids. RESULTS: Change of median insulin AUC was -53.0 microIU/mL (IQR, -126.0 to -12.7) in the BFL group vs. +33.6 microIU/mL (IQR, 7.0 to 115.6) (p = .01) in PBO group. Weight decreased significantly in the BFL group (-2 kg +/- 2.6; IQR, -6.8 to 2.0) compared to the PBO group (0.8 kg +/- 1.7; IQR, -2.0 to 0.5) (p = .02). No significant changes in visceral or subcutaneous fat mass and plasma lipid level were observed between the two groups. CONCLUSION: Added to antiretroviral therapy, a 6-month therapy with BFL improved insulin sensitivity but is not sufficient to reduce significantly visceral fat mass.
Subject(s)
Fenfluramine/analogs & derivatives , Glucose Intolerance/drug therapy , HIV-1 , HIV-Associated Lipodystrophy Syndrome/drug therapy , Hypolipidemic Agents/therapeutic use , Insulin Resistance , Adult , Antiretroviral Therapy, Highly Active/adverse effects , Double-Blind Method , Female , Fenfluramine/therapeutic use , HIV-Associated Lipodystrophy Syndrome/chemically induced , Humans , Insulin/therapeutic use , Male , Middle Aged , Treatment OutcomeABSTRACT
This study presents a case-control nested analysis of cervical squamous intraepithelial lesions (SIL) in a cohort of 423 HIV-infected women with registered Pap smears between 1991 and 2004. Data on Pap smear results, CDC HIV classification, CD4 cell count and antiretroviral therapy were prospectively collected. Pap smears were classified using the Bethesda classification. Women had a median of three Pap smears registered in the database. The first Pap smear was registered Subject(s)
Antiretroviral Therapy, Highly Active/adverse effects
, Carcinoma, Squamous Cell/pathology
, Uterine Cervical Neoplasms/pathology
, Adolescent
, Adult
, Aged
, Antiretroviral Therapy, Highly Active/methods
, Carcinoma, Squamous Cell/chemically induced
, Case-Control Studies
, Cohort Studies
, Female
, HIV Seropositivity/complications
, Humans
, Middle Aged
, Papanicolaou Test
, Prospective Studies
, Treatment Outcome
, Uterine Cervical Neoplasms/chemically induced
, Vaginal Smears/methods
ABSTRACT
This retrospective and longitudinal study evaluated the long-term hepatic tolerance of a nelfinavir (NFV)-antiretroviral combined regimen in 82 patients of the HCV-HIV Cohort of CISIH-Sud of Marseilles. Follow-up data (liver enzyme levels, CD4 cell count, HIV viral load, and metabolic parameters) of patients treated with NFV on inclusion or during the follow-up of the cohort were analyzed under treatment over 24 months. Comparisons were performed with X2 or Kruskal-Wallis tests. At baseline (n = 82), the median exposure to NFV was 4.1 months; 58 patients received NFV combined with NRTI and 24 with NNRTI. The median CD4 cell count was 337/mm3 [interquartile range (IR): 216-480) and 39.7% had an undetectable HIV RNA level. Qualitative HCV PCR was positive in 91% of the patients and 19/51 patients with liver biopsy were F3-F4. Median alanine and aspartate aminotransferase (ALAT, ASAT), gamma-glutamyltransferase (GT), and alkaline phosphatase (ALP) were 46 UI/liter (IR: 36-76), 55 UI/liter (IR: 32-97), 97 UI/liter (IR: 50-194), and 88 UI/liter (IR: 72-104), respectively, with 76% of the patients with ALAT/ASAT grade <2. Median follow-up was 23 months (IR: 13.8-37). No significant difference was observed in the distribution of ALAT, ASAT, GT, and ALP as well as of ALAT/ASAT grades over the 24-month study period. Patients treated with NFV + NNRTI had significantly higher GT and ALP levels at baseline with no significant increase during follow-up. Cholesterol, triglyceride, and glycemia distributions remained stable over time. In conclusion, this study showed a good hepatic and metabolic tolerance of a long-term NFV-combined regimen in HIV-HCV coinfected patients.
Subject(s)
HIV Infections/drug therapy , Hepatitis C/drug therapy , Nelfinavir/therapeutic use , Reverse Transcriptase Inhibitors/therapeutic use , Adult , CD4 Lymphocyte Count , Cohort Studies , Drug Therapy, Combination , Female , HIV Infections/complications , Hepatitis C/complications , Humans , Male , Nelfinavir/administration & dosage , Reverse Transcriptase Inhibitors/administration & dosage , Viral LoadSubject(s)
AIDS-Related Opportunistic Infections/microbiology , Antiretroviral Therapy, Highly Active/adverse effects , Brain Abscess/microbiology , Immunocompromised Host , Mycobacterium avium-intracellulare Infection/diagnosis , Mycobacterium avium/isolation & purification , AIDS-Related Opportunistic Infections/drug therapy , Adult , Anti-Bacterial Agents , Antiretroviral Therapy, Highly Active/methods , Antitubercular Agents/therapeutic use , Brain Abscess/drug therapy , Brain Abscess/pathology , Drug Therapy, Combination/therapeutic use , Follow-Up Studies , Humans , Male , Mycobacterium avium-intracellulare Infection/drug therapy , Rare Diseases , Risk Assessment , Severity of Illness Index , Treatment OutcomeABSTRACT
PURPOSE: To evaluate tolerance and efficacy of an open-label interferon-ribavirin treatment and their determinants in 62 HCV-HIV coinfected patients in routine followup. METHOD: Patients received at least 6 and up to 12 months of combination interferon alpha-2b (peg or not) plus ribavirin. Determinants of therapeutic success were estimated by a multivariate logistic regression. RESULTS: Five patients stopped the study, 4 were lost to follow-up, and 53 participated in the entire therapeutic protocol. Among these 53, the end-of-treatment results showed complete clearance of HCV-RNA in 17 (32%). A sustained virologic response (SVR) after 6 or 9 months was observed in 9 (17%) patients, 3 relapsed, and data were not available for 5. Genotype 3a (odds ratio [OR] = 14.4; confidence interval [CI] = 1.84-110.3) favored SVR and treatment with protease inhibitor (PI) therapeutic resistance (OR = 14.4; CI = 1.01-200); as well, a higher fibrosis score tended to increase resistance (p =.11). Adverse events were reported by 24/53 patients (45.3%). CONCLUSION: HCV therapy associating interferon and ribavirin in HCV-HIV coinfected patients is well accepted even if tolerance is moderate. Treatment permitted SVR in at least 17% of the cases. This is likely when patients initiate treatment at the early fibrosis stage and are infected with genotype 3a. The potential interaction with PI therapy should be explored.