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PubMed1986

Susceptibility of strains of Mycobacterium leprae isolated prior to 1977 from patients with previously untreated lepromatous leprosy.

Because of the recent spate of reports of primary resistance to dapsone among patients with lepromatous leprosy, largely to small concentrations of the drug, a survey was made of the results of dapsone-susceptibility testing of strains of Mycobacterium leprae isolated before 1977 among six laboratories which employed the mouse foot pad technique for this work prior to that time. Data have been found for strains that had been isolated from 73 patients, representing 19 countries and dependencies, with previously untreated lepromatous leprosy; all 73 strains were inhibited from multiplication by dapsone administered to mice in a concentration of 0.0001 g per 100 g mouse diet. These data suggest that the properties of M. leprae isolated from previously untreated patients with respect to susceptibility to dapsone have changed since the years preceding 1977.

Animals↗
PubMed1986

[Sulfone-resistance of Mycobacterium leprae--monotherapy with diaminodiphenylsulfone--the value of triple-drug combinations].

While the emergence of drug resistance in Mycobacterium leprae was foreseen and known for a long time, it is now presented as a tragedy jeopardizing leprosy control through monotherapy. This resistance has been mainly reported in the United States. It is not observed in other parts of the world. In our opinion, the unfavorable observations made at present result from an incorrect implementation of dapsone (DDS) therapy in the patients, resulting in low sulfone blood levels, as a consequence of the use of complex disubstituted sulfones, insufficient daily dapsone dosages, irregular or noncompliance to treatment, premature interruption of treatment, etc. Two measures are required in order to prevent the emergence of primary or secondary resistance to dapsone in M. leprae. First, it is necessary to go back to the previous regimen of 200 mg dapsone daily in an adult. It yields the "maximum tolerated effective dosage." It should never have been rejected in favor of 100 mg daily as currently recommended at the moment. The second measure is the implementation of multiple drug therapy (MDT), using concurrently DDS in association with rifampin and clofazimine. This is a logical and rational approach, at least from a theoretical point of view. However, MDT is most unfortunately quite expensive and therefore inapplicable in most countries with high prevalence, since they are poor and underdeveloped. Implementation of MDT also raises great problems, since dosages have to be strictly adhered to in order to prevent a potentially catastrophic emergence of multiple drug resistance in M. leprae.

Clofazimine↗
PubMed1985

Temperature-induced changes in viability, diphenoloxidase and permeability of Mycobacterium leprae.

Among mycobacteria secretion of the enzyme diphenoloxidase has been established as a property of Mycobacterium leprae. The antileprosy drug dapsone (DDS), which completely inhibits the enzyme from plant and mammalian sources, does not readily penetrate intact M. leprae. When the drug is complexed with polylysine, it easily permeates the bacteria and produces 100% inhibition of its diphenoloxidase, suggesting a permeability barrier of the cytoplasmic membrane of M. leprae to dapsone. In this study: (1) when the organisms, purified from fresh tissues of experimentally infected armadillos, were treated with dilute alkali or exposed to warmer temperatures, DDS penetrated the bacteria and inhibited the diphenoloxidase. Washing with trypsin had no effect. Dapsone easily permeated the bacilli, purified from tissues stored at 0 degrees C or at -80 degrees C. (2) Diphenoloxidase of freshly-prepared M. leprae was stimulated when the bacteria were exposed to 50 degrees C for 10 min; at 60 degrees C the activity decreased, and at 100 degrees C the enzyme was completely inactivated. When the enzyme was assayed at temperatures below 37 degrees C, the activity was considerably lower, indicating that M. leprae may not be a psychrophilic organism in this respect. (3) The bacteria exposed to 50 degrees C failed to multiply in mouse footpads. M. leprae remained viable in tissues stored at 0 degrees C or -80 degrees C; but when the bacteria purified from these tissues were frozen, they lost their viability. On the other hand, the organisms separated from fresh tissues remained viable when frozen at -80 degrees C. The inhibition of diphenoloxidase of M. leprae by dapsone could serve as an indirect method to assess the integrity of the bacterial cell membrane and to predict whether the bacteria would retain their viability on freezing.

Catechol Oxidase↗
PubMed1983

Studies on sulphone resistant strains of M. leprae in field and institutionalized cases of leprosy.

The proportions of dapsone resistant strains of M. leprae in cases from the field and in patient institutionalized for treatment were compared. Identification of dapsone resistance was done by mouse-foot-pad experiments carried out in the Laboratory in Central Leprosy Teaching and Research Institute, Chengalpattu. A higher percentage of resistance was detected among institutional patients as compared to field cases. The distribution of M.I. ranges of M. leprae in dapsone resistant subjects was not different from that in dapsone sensitive cases.

Animals↗
PubMed1983

Influence of agents with immunomodulating activity on phagocytosis and bactericidal function of human polymorphonuclear cells.

Six immunomodulators were tested for the influence on phagocytosis and intracellular bactericidal activity of human polymorphonuclear cells (PMN). Frentizole, lamprene, intal and levamisole but not dapsone enhanced phagocytosis in the presence of serum. Without serum, frentizole strongly enhanced phagocytosis, whereas lamprene, levamisole and dapsone had weaker enhancing activity. Rifampin suppressed phagocytosis of Staphylococcus aureus whether the serum was present or not. The influence on phagocytosis was time and dose dependent. All drugs but dapsone markedly enhanced intracellular bactericidal activity of PMN in a dose dependent fashion. Dapsone enhanced bactericidal activity without the serum and suppressed it in its presence. It may be concluded that immunomodulators are a heterogeneous group of substances and their influence on phagocytosis and cellular bactericidal activity varies. Enhancing activity of some immunomodulators implies that they may be used in conditions with impaired phagocytosis.

Adjuvants, Immunologic↗
PubMedDate not supplied

Permeation of lipophilic drugs through synthetic elastomers.

Permeability studies were carried out with three lipophilic drugs, namely, phenytoin and primidone (both widely used in the treatment of epilepsies and convulsive disorders), and dapsone (a sulfone antimicrobial agent used in the treatment of leprosy and to a lesser extent in dermatitis herpetiformis) through silica-filled poly(dimethyl siloxane) (Silastic) membranes, and anisotropic membranes of poly(ether-urethane)/poly(dimethyl siloxane) block copolymer (Avcothane, Cardiothane). These polymers are used in medical implants and in various cardiovascular devices. While both polymers were permeable to the drugs, the transport properties differed significantly. In the case of the poly(dimethyl siloxane) there was an initial large burst effect, followed by an exponential decrease in the rate of drugs released through the polymer films, although with dapsone the release rate became essentially constant between 100-180 h at 37 degrees C. In the case of the anisotropic films of the poly(ether-urethane)/poly(dimethyl siloxane) block copolymer, the permeabilities were much higher. Significantly, phenytoin exhibited essentially constant rate (zero-order) kinetics between 25-150 h, showing only a moderate burst effect that is probably not significant therapeutically. Importantly, dapsone showed neither a burst effect nor any significant time lag, and the release followed constant rate (zero-order) kinetics between 12-80 h, followed by only a moderate decrease in drug concentration up to 140 h (the experimental end-point). The diffusion coefficients calculated from initial desorption data at 37 degrees C for the poly(ether-urethane)/poly(dimethyl siloxane) block copolymer are as follows: phenytoin = 8.6 X 10(-9) cm2/s, primidone = 2.8 X 10(-9) cm2/s, and dapsone = 2.4 X 10(-8) cm2/s.(ABSTRACT TRUNCATED AT 250 WORDS)

Dapsone↗
PubMed1993

Problems of leprosy relapse in China.

The proportion of relapses among all patients detected each year increased steadily since the initiation of the national leprosy control program in China with dapsone monotherapy in 1955, reaching 18%-24% in the more leprosy-endemic provinces along the coast. Relapses were also reported in the formerly rifampin-plus-dapsone-treated patients. So far, only three paucibacillary relapses after 6 months of multidrug therapy (MDT) have been reported, and these were due to misclassification at the time of diagnosis. A short course of MDT should be given to all formerly dapsone- and/or rifampin-plus-dapsone-cured patients for the prevention of relapse. If not, they should be screened every 1 to 2 years for any possible signs of relapse, and MDT given when needed.

China↗
PubMed1996

Drug resistance in Nepali leprosy patients.

Although multidrug therapy (MDT) was introduced into Nepal in 1983, the MDT coverage only recently exceeded 67%. In view of the large number of patients who were still receiving dapsone monotherapy, it is relevant to investigate the current levels of dapsone and rifampin resistance. The study was undertaken at a leprosy referral hospital near Kathmandu. Over a 5 1/2-year period, 157 leprosy patients with a bacterial index (BI) > or = 2.0 were investigated for drug resistance according to the method of Rees. Among previously untreated cases, 6% of 88 isolates showed low-dose dapsone resistance; among previously treated patients with a presumed relapse, 47% of 34 isolates demonstrated dapsone resistance. In the remaining 35 cases there was no growth in control mice. Rifampin resistance was not confirmed in any case.

Adolescent↗
PubMedDate not supplied

Clinical features and management of poisoning due to antimalarial drugs.

The toxicities of antimalarial drugs vary because of the differences in the chemical structures of these compounds. Quinine, the oldest antimalarial, has been used for 300 years. Of the 200 to 300 compounds synthesised since the first synthetic antimalarial, primaquine in 1926, 15 to 20 are currently used for malaria treatment, most of which are quinoline derivatives. Quinoline derivatives, particularly quinine and chloroquine, are highly toxic in overdose. The toxic effects are related to their quinidine-like actions on the heart and include circulatory arrest, cardiogenic shock, conduction disturbances and ventricular arrhythmias. Additional clinical features are obnubilation, coma, convulsions, respiratory depression. Blindness is a frequent complication in quinine overdose. Hypokalaemia is consistently present, although apparently self-correcting, in severe chloroquine poisoning and is a good index of severity. Recent toxicokinetic studies of quinine and chloroquine showed good correlations between dose ingested, serum concentrations and clinical features, and confirmed the inefficacy of haemodialysis, haemoperfusion and peritoneal dialysis for enhancing drug removal. The other quinoline derivatives appear to be less toxic. Amodiaquine may induce side effects such as gastrointestinal symptoms, agranulocytosis and hepatitis. The main feature of primaquine overdose is methaemoglobinaemia. No cases of mefloquine and piperaquine overdose have been reported. Overdose with quinacrine, an acridine derivative, may result in nausea, vomiting, confusion, convulsion and acute psychosis. The dehydrofolate reductase inhibitors used in malaria treatment are sulfadoxine, dapsone, proguanil (chloroguanide), trimethoprim and pyrimethamine. Most of these drugs are given in combination. Proguanil is one of the safest antimalarials. Convulsion, coma and blindness have been reported in pyrimethamine overdose. Sulfadoxine can induce Lyell and Stevens-Johnson syndromes. The main feature of dapsone poisoning is severe methaemoglobinaemia which is related to dapsone and to its metabolites. Recent toxicokinetic studies confirmed the efficacy of oral activated charcoal, haemodialysis and haemoperfusion in enhancing removal of dapsone and its metabolites. No overdose has been reported with artemesinine, a new antimalarial tested in the People's Republic of China. The general management of antimalarial overdose include gastric lavage and symptomatic treatment.(ABSTRACT TRUNCATED AT 400 WORDS)

Antimalarials↗
PubMed2006

[Leishmania infantum/HIV co-infection: cutaneous lesions following treatment of visceral leishmaniasis].

BACKGROUND: The Mediterranean basin is an endemic region of leishmaniasis caused by Leishmania infantum. With the advent of human immunodeficiency virus (HIV) infection, the number of cases of visceral leishmaniasis has dramatically increased in this area over the last years, mainly in adults. Moreover, the presence of cutaneous lesions infested with Leishmania has been frequently reported in these patients. CASE-REPORT: A 35-year-old Portuguese woman, a former intravenous drug user HIV1-positive since 1997, developed visceral leishmaniasis in 2000, with several relapses in 2001 and 2002, treated successively with pentavalent antimonial salts (Glucantime), liposomal amphotericin B and Glucantime associated with itraconazole. Several weeks after therapy for the second relapse of visceral leishmaniasis, physical examination revealed asymptomatic erythematous papules on the face that later spread to the trunk and upper limbs. Histopathologic studies of a skin biopsy revealed a granulomatous infiltrate in the dermis with the presence of Leishmania amastigotes. After culture, the parasite was identified as L. infantum MON-1. In spite of improvement of the patient's visceral leishmaniasis with the above-mentioned treatment, the cutaneous lesions became increasingly numerous and infiltrated. After 2 months of therapy with intravenous pentamidine (4 mg/kg/3 times a week) and oral dapsone (100 mg b.i.d), the cutaneous lesions disappeared completely. Prevention with dapsone was successfully maintained for 6 months. Several weeks after discontinuation of treatment, further lesions appeared. The patient improved again on reintroduction of dapsone. DISCUSSION: This case confirmed the existence of a clinical form similar to post-kala-azar dermal leishmaniasis in a patient co-infected with L. infantum MON-1/HIV. The cutaneous lesions were resistant to classical antileishmanial drugs but disappeared on treatment with dapsone.

Adult↗
PubMed1996

Association of low CYP3A activity with p53 mutation and CYP2D6 activity with Rb mutation in human bladder cancer.

p53 and Rb gene mutations are intermediate biomarkers useful for the prediction of neoplastic progression in bladder cancers. Previously, we have shown that low CYP3A activity, measured by dapsone N-hydroxylation, and high CYP2D6 activity, assessed by debrisoquine 4-hydroxylation, were significant susceptibility risk factors in developing aggressive bladder cancer. However, no information is available about the relationship between drug/xenobiotic metabolizing enzyme activities and p53/Rb mutations that may suggest mechanisms of bladder carcinogenesis. We evaluated in vivo CYP3A activity by the dapsone recovery ratio (DPRR), CYP2D6 activity by the debrisoquine recovery ratio (DBRR), CYP2C19 activity by the mephenytoin R/S ratio (RSR), N-acetyltransferase activity by the monoacetyl dapsone to dapsone ratio and glutathione-S-transferase M1 (GSTM1) genotype by PCR. In immunohistochemical studies of bladder tumor tissue, over expression of p53 protein was detected with antibody pAb1801 and loss of Rb protein expression was evaluated with antibody PMG3-245 in patients with transitional cell carcinoma of the bladder. Low CYP3A activity was significantly associated with over expression of or mutated p53 protein (P < 0.05). High CYP2D6 activity (within the extensive metabolizer group) was significantly associated with loss of expression of or mutated Rb protein (P < 0.05). Positive p53 staining also predicted aggressive bladder cancer histopathology (P < 0.05, odds ratio 2.9), and the lowest tertile of DPRR predicted p53 positivity (P < 0.01, odds ratio 3.9 comparing means of lower tertile versus upper tertile of DPRR). These selective associations are consistent with the hypothesis that an environmental pro-carcinogen fails to be detoxified by CYP3A which may preferentially induce p53 mutations, whereas, an alternative pro-carcinogen that may be activated by CYP2D6, may selectively induce Rb mutations.

Aged↗
PubMed1990

The effects of drugs on Sephadex-induced eosinophilia and lung hyper-responsiveness in the rat.

1. Rats given an intravenous injection of Sephadex particles (0.5 mg of G200 in 1 ml of saline) on days 0, 2 and 5 had a blood eosinophilia which was maximal on day 7. 2. On day 7, broncho-alveolar lavage (BAL) fluids taken from the rats contained an increased number of eosinophils and fewer mononuclear cells but there was no change in the small number of neutrophils. In addition the rats were hyper-sensitive to the increase in resistance to artificial respiration produced by 5-hydroxytryptamine (5-HT), given intravenously, with a shift to the left of the log dose-response curve. Lung parenchymal strips, taken from the rats on days 6, 7 and 8, were hyper-reactive to 5-HT with an increase in slope of the log dose-response curve. 3. Compounds with a wide variety of activities were evaluated for their effects on the blood eosinophilia on day 7 when given before each injection of Sephadex. The eosinophilia was reduced by glucocorticosteroids, beta-adrenoceptor agonists, aminophylline, dapsone and phenidone. 4. Dexamethasone, isoprenaline, dapsone and phenidone at doses that reduced the blood eosinophilia also reduced the changes in number of leucocytes in the BAL fluids and the hyper-responsiveness to 5-HT in vivo and in vitro, except that the effects of dapsone on the hyper-sensitivity to 5-HT in vivo did not reach significance. Aminophylline was the least effective of the drugs at reducing the blood eosinophilia and its effects on the other changes did not reach significance. Sodium cromoglycate reduced the BAL eosinophilia but had no effect on the other changes produced by Sephadex. 5. The correlation coefficients between blood eosinophil numbers and reactivity to 5-HT in vitro and sensitivity in vivo were r = 0.76, (n = 88; P < 0.001) and r = 0.53, (n = 61; P < 0.001) respectively. 6. Doses of dexamethasone, isoprenaline, dapsone and phenidone that reduced the blood eosinophilia when given before each injection of Sephadex were inactive when given up to 8 h after the Sephadex. 7. These data show an association between blood eosinophilia and hyper-responsiveness of the lung. The blood eosinophilia in the rats was triggered within the first few hours of injecting the Sephadex and drugs have been identified which inhibit this trigger.

Animals↗
PubMed2000

[Guideline for the treatment of Hansen's disease in Japan].

Ad hoc committee of Japanese Leprosy Association recommends standard treatment protocol of leprosy in Japan, which is a modification of World Health Organization's multidrug therapy (WHO/MDT, 1997). For paucibacillary (PB) leprosy, 6 months treatment by rifampicin and dapsone (MDT/PB) is enough. However, for high bacterial load multibacillary (MB) leprosy, 12 months treatment seems insufficient. Thus, (A) For MB with bacterial index (BI) > or = 3 before treatment, 2 years treatment by rifampicin, dapsone and clofazimine (MDT/MB) is necessary. (A-1) When satisfactory decrease of BI (BI value decrease > or = 2 steps, or final BI < 3) is obtained after completion of 2 years MDT/MB, maintenance therapy by dapsone and clofazimine is recommended until BI negativity and loss of active lesions. (A-2) When BI decrease is not satisfactory (BI value decrease < 2 steps, or final BI > or = 3), MDT/MB should be continued until BI negativity and loss of active lesions. (B) For MB with BI < 3 or fresh MB (less than 6 months after the onset of the disease) with BI > or = 3, 1 year treatment by rifampicin, dapsone and clofazimine (MDT/MB) is necessary. (B-1) When BI become negative and active lesion is lost within one year, no maintenance therapy is necessary. (B-2) When BI is still positive or active lesion is remaining, additional therapy with MDT/MB for one more year is recommended. Brief summary of diagnosis, purpose of therapy, character of drugs, and prevention of deformity is also described.

Drug Therapy, Combination↗
PubMed2000

Serum levels of autoantibodies to BP180 correlate with disease activity in patients with bullous pemphigoid.

OBJECTIVE: To investigate the possible correlation of levels of circulating anti-BP180 autoantibodies with disease activity in bullous pemphigoid (BP). DESIGN: Diagnostic study. SETTING: Regional referral center at a university dermatology department. PATIENTS: Fifteen patients with typical clinical, histologic, and immunofluorescence findings of BP who had not received prior systemic treatment. INTERVENTIONS: Initially, 6 consecutive patients with BP were treated with oral doxycycline and niacinamide. Subsequently, 9 consecutive patients with BP received a combination of oral dapsone and prednisolone. MAIN OUTCOME MEASURES: Disease activity, serum levels of autoantibodies to BP180, and titers of antibasement membrane zone autoantibodies were assayed before initiation of treatment and 4 and 8 weeks later. Reactivity to BP180 was analyzed by enzyme-linked immunosorbent assay using a recombinant form of BP180 NC16A. Titers of anti-basement membrane zone autoantibodies were assayed by indirect immunofluorescence on 1-mol/L sodium chloride-split human skin. RESULTS: In both treatment groups, disease activity correlated with serum levels of autoantibodies to BP180 NC16A (P = .004 [dapsone-prednisolone] and .007 [doxycycline-niacinamide]). No correlation was seen between disease activity and indirect immunofluorescence reactivity (P = .18 and .16, respectively). In patients receiving dapsone plus prednisolone, the dose of corticosteroids necessary to suppress new blister formation correlated with anti-BP180 reactivity (P = .002). CONCLUSIONS: In contrast to indirect immunofluorescence reactivity that reflects reactivity to both BP 180 and BP230, serum levels of autoantibodies to BP180 correlate with disease activity in BP. Assaying reactivity to BP180 should be a helpful guide for the therapeutic management of patients with this disease. Our results underline the pathogenic relevance of autoantibodies to human BP180.

Aged↗
PubMed2002

Prophylaxis for human immunodeficiency virus-related Pneumocystis carinii pneumonia: using simulation modeling to inform clinical guidelines.

BACKGROUND: Human immunodeficiency virus (HIV)-infected patients receiving highly active antiretroviral therapy (HAART) have experienced a dramatic decrease in Pneumocystis carinii pneumonia (PCP), necessitating reassessment of clinical guidelines for prophylaxis. METHODS: A simulation model of HIV infection was used to estimate the lifetime costs and quality-adjusted life expectancy (QALE) for alternative CD4 cell count criteria for stopping primary PCP prophylaxis in patients with CD4 cell count increases receiving HAART and alternative agents for second-line PCP prophylaxis in those intolerant of trimethoprim-sulfamethoxazole (TMP/SMX). The target population was a cohort of HIV-infected patients in the United States with initial CD4 cell counts of 350/microL who began PCP prophylaxis after their first measured CD4 lymphocyte count less than 200/microL. Data were from randomized controlled trials and other published literature. RESULTS: For patients with CD4 cell count increases during HAART, waiting to stop prophylaxis until the first observed CD4 cell count was greater than 300/microL prevented 9 additional cases per 1000 patients and cost $9400 per quality-adjusted life year (QALY) gained compared with stopping prophylaxis at 200/microL. For patients intolerant of TMP/SMX, using dapsone increased QALE by 2.7 months and cost $4500 per QALY compared with no prophylaxis. Using atovaquone rather than dapsone provided only 3 days of additional QALE and cost more than $1.5 million per QALY. CONCLUSIONS: Delaying discontinuation of PCP prophylaxis until the first observed CD4 cell count greater than 300/microL is cost-effective and provides an explicit "PCP prophylaxis stopping criterion." In TMP/SMX-intolerant patients, dapsone is more cost-effective than atovaquone.

AIDS-Related Opportunistic Infections↗
PubMed2004

Unusual clinical manifestation of linear IgA dermatosis: a report of two cases.

Linear IgA dermatosis is a rare autoimmune bullous skin disease with subepidermal blister formation and linear IgA deposits along the basement membrane zone. We describe two female patients showing erythematous annular plaques with scaling at the margin, strictly localized to the palms in one patient, and also found on the soles and buttocks in the second patient. Histology showed numerous neutrophils in the dermis with an admixture of eosinophils, some subepidermal clefting, and occasional papillary microabscesses. Direct immunofluorescence and immunoelectron microscopy revealed in vivo IgA deposition along the basement membrane zone. One patient cleared after treatment with dapsone. The second patient did not respond to dapsone alone and various immunosuppressive treatment regimens. Considerable improvement was achieved with intravenous immunoglobulin therapy combined with corticosteroid and dapsone.

Adult↗
PubMed2004

[Sneddon-Wilkinson disease. Four cases report].

INTRODUCTION: We report four cases of subcorneal pustular dermatosis or Sneddon-Wilkinson disease. Clinical and histological lesions and immunofluorescence data were presented. This disease is classified among neutrophilic dermatitis. PATIENTS AND METHODS: All of four patients presented with clinical and histological lesions compatible with the diagnosis of Sneddon-Wilkinson disease. Indeed, direct and indirect immuno-testing were negative. We noted an association with a benign IgA monoclonal gammapathy in one case and with a seronegative polyarthritis in one other case. Three patients correctly responded to dapsone. One of them after transient improvement was resistant to dapsone and then dramatically responded to etretinate. CONCLUSION: Subcorneal pustular dermatosis is a chronic disease, rarely described in literature. It's a pustular eruption, involving the trunck, axillae and inguinal holds. It's often associated with monoclonal gammapathy, particulary IgA. Its nosological situation is still contested, especially with IgA pemphigus sharing with it the association with IgA monoclonal gammapathy and the same efficacy of dapsone. We discuss relationships between both diseases.

Aged↗
PubMed1996

Adverse events from drug therapy for human immunodeficiency virus disease.

PURPOSE: Drug therapies for patients with human immunodeficiency virus (HIV) infection are associated with adverse events that can potentially limit their effectiveness. We sought to quantify the incidence of these events in clinical practice and determine whether there were demographic and clinical differences in adverse event rates for these drugs. PATIENT AND METHODS: We calculated specific and overall adverse event rates from use of zidovudine, didanosine, zalcitabine, cotrimoxazole, and dapsone in an observational urban cohort of 1,450 HIV-infected patients with a CD4+ count of 500 cells/mm3 or less. We compared adverse event rates by gender, race, age, injecting drug use, and CD4+ count. RESULTS: Overall adverse event rates in order of incidence were dapsone, 16.2 per 100 person-years (PY); didanosine, 24.1 per 100 PY; zidovudine, 26.3 per 100 PY; cotrimoxazole, 26.3 per 100 PY; and zalcitabine, 37.0 per 100 PY. Rates increased significantly with decline in CD4+ count from > 200 to < 100 cells/mm3 for all drugs but dapsone. In addition, women were more likely than men to have an adverse event for didanosine (relative risk [RR] = 2.7, P = 0.03) and from cotrimoxazole (RR 1.5; P = 0.05). Whites were at greater risk than blacks for adverse events from cotrimoxazole (RR = 1.6, P = 0.03). Only 22 of 357 total events (6%) required hospitalization, and there were no deaths. CONCLUSIONS: Adverse events from antiretroviral drugs and Pneumocystis carinii pneumonia prophylaxis that interrupt therapy are relatively common, although serious events requiring hospitalization are rare. Adverse event rates increase progressively with decline in CD4+ count. The gender and race of the patient modify the risk of adverse events for some drugs.

Adult↗