| 1997 | Zidovudine toxicity in uninfected healthcare workers. Italian Registry of Antiretroviral Prophylaxis. | Am J Med | To evaluate the toxicity of zidovudine (ZDV) prophylaxis in human immunodeficiency virus (HIV)-exposed healthcare workers (HCWs) in Italy, a national protocol for postexposure prophylaxis has been implemented and a national registry has been established. All Italian clinical centers licensed to dispense ZDV participate. As of December 1995, data from 674 individuals who received ZDV prophylaxis have been collected. In three cases ZDV was used in combination with either didanosine (DDI) or dideoxycytidine (DDC). In 556 cases (82%), the daily dose of ZDV was 1,000 mg/day; 21 HCWs (3%) were treated with 300-800 mg/day, and in 72 persons (11%) the dose was 1,200-3,000 mg/day. A total of 332 (49%) HCWs reported at least one adverse effect; 132 (20%) discontinued prophylaxis because of side effects (40% of those reporting side effects). Nausea was reported in 243 cases; other side effects included vomiting, gastric pain, diarrhea, asthenia, and headache. Most constitutional adverse effects were reported during the first week of prophylaxis. Grade 1 anemia (hemoglobin 9.5-11 g/dL) occurred in 10 cases (3%); in 2 cases, the neutrophil count decreased to <1,000 cells/mm3. A transient increase of serum alanine aminotransferase to three times the upper limit of normal was observed in 7 persons. All side effects were reversible after the prophylaxis was stopped. Among those reporting at least one side effect the mean duration of treatment was 22 days; for HCWs reporting hematologic or liver adverse effects the mean length of treatment was 34 days. A total of 351 HCWs (54.6%) ceased the treatment before the scheduled 1-month period. In the 132 persons who discontinued treatment because of side effects, the mean length of prophylaxis was 8 days. One HCW seroconverted after conjunctival exposure to blood. The short-term toxicity of ZDV prophylaxis is frequent, mild, dose related, and reversible. Further studies are needed to assess the risk of long-term sequelae of this treatment as well as of prophylaxis with combinations of antiretroviral drugs. |
| 1995 | Evaluation of safety and efficacy of 3TC (lamivudine) in patients with asymptomatic or mildly symptomatic human immunodeficiency virus infection: a phase I/II study. | J Infect Dis | In a phase I/II study, 7 levels of 3TC therapy (from 0.5 to 20.0 mg/kg/day) were studied in 104 asymptomatic and mildly symptomatic human immunodeficiency virus-infected patients with CD4 cell counts < or = 400 x 10(6)/L. Mild and transient episodes of diarrhea, headache, fatigue, nausea, and abdominal pain were the most frequent events reported. No dose-limiting toxicities were observed. Small and transient increases in CD4 cell counts were detected during the first 4 weeks of treatment. These were followed by progressive declines during prolonged therapy. Sustained decreases in beta 2-microglobulin, neopterin, and p24 antigen levels were seen over the 52-week study. There was no consistent dose-response correlation for any surrogate marker. Penetration of 3TC into cerebrospinal fluid (CSF) was in the same range as reported for ddC and ddI; the mean CSF-to-serum ratio was 0.06. These findings indicate that 3TC exhibits an excellent safety profile and has antiretroviral activity at the dosages studied. |
| 1994 | [Therapy for HAM/TSP and AIDS]. | Nihon Rinsho | (1) We evaluated efficacy of several treatments for HTLV-I-associated myelopathy (HAM) on the basis of our study on 254 HAM patients and of literature review. Improvement of motor disability more than fair response was obtained as follows: 82% in prednisolone, 69% in interferon-alpha, 92% in fosfomycin, 82% in high-dose vitamin C, 72% in blood purification therapy, 70% in heparin, 59% in salazosulfapyridine, 56% in thyrotropin-releasing hormone, 55% in erythromycin, 50% in mizoribine. (2) In the absence of clear guideline, the efficacy of zidovudine in the AIDS dementia complex has been demonstrated. There are also efficacy of amytriptylinein controlling HIV headache, corticosteroid in mononeuritis multiple and inflammatory myositis, hydrocortisone in autonomic neuropathy and plasmapheresis in distal sensory neuropathy respectively. Otherwise, it is emphasized that ddI, ddC and d4T have peripheral neuropathy as major, dose related side effect. |