Didanosine, lamivudine, and efavirenz versus zidovudine, lamivudine, and efavirenz for the initial treatment of HIV type 1 infection: final analysis (48 weeks) of a prospective, randomized, noninferiority clinical trial, GESIDA 3903.

BACKGROUND: The combination of didanosine, lamivudine, and efavirenz (ddI/3TC/EFV) for the initial treatment of human immunodeficiency virus type 1 (HIV-1) infection has been insufficiently analyzed in clinical trials. METHODS: We conducted an open-label, randomized study to compare the noninferiority of ddI/3TC/EFV with the lamivudine-zidovudine tablet and EFV (COM/EFV), both administered with food to improve tolerability and convenience. Patients were stratified by HIV-1 RNA level of <5.0 log(10) or > or =5.0 log(10) copies/mL. The primary end point was the percentage of patients with an HIV-1 RNA level of <50 copies/mL at week 48, determined by intention-to-treat analysis. RESULTS: Three hundred sixty-nine patients were randomized: 186 for ddI/3TC/EFV treatment and 183 for COM/EFV treatment. Both groups were well matched in terms of baseline characteristics; 19.3% of patients received a Centers for Disease Control and Prevention assessment of clinical category C, median HIV RNA level was 5.0 log(10) copies/mL, and median CD4(+) cell count was 208 cells/microL. At week 48, by intention-to-treat analysis, 70% of patients in the ddI/3TC/EFV group and 63% of patients in the COM/EFV group had an HIV-1 RNA level of <50 copies/mL (treatment difference, 7.1%; 95% confidence interval, -2.39% to 16.59%). Fourteen patients (8%) in the ddI/3TC/EFV arm (not the COM/EFV arm) and 26 patients (14%) in the COM/EFV arm (not the ddI/3TC/EFV arm) [corrected] discontinued the study medication because of adverse events (P = .046). One patient (1%) in the ddI/3TC/EFV arm and 11 patients (6%) in the COM/EFV arm discontinued medication because of hematological toxicity (P = .003). CONCLUSIONS: At week 48, ddI/3TC/EFV administered once per day with food did not have results inferior to those of COM/EFV treatment. A statistically significantly higher proportion of patients in the COM/EFV arm than in the ddI/3TC/EFV arm discontinued therapy because of adverse events, mainly because of hematological toxicity. CLINICAL TRIALS REGISTRATION: NCT00256828.

Simplified therapy with zidovudine, lamivudine, and abacavir for very nonadherent, treatment-failing patients.

OBJECTIVE: To assess the effectiveness of a simplified therapy for very nonadherent patients who had previously failed with HAART. METHOD: We performed a prospective open-label study of antiretroviral-experienced patients. Dosing schedule comprised (co-formulated) zidovudine, lamivudine, and abacavir bid. Eligible patients had to have plasma HIV RNA >5000 copies/mL, previous therapy, and very poor adherence to the medication regimen. RESULTS: Eighty-five patients were included (mean viral load, 4.4 log/mL; mean CD4, 240 cells/mL; IDUs, 78%; methadone maintenance program, 42%; AIDS, 28%). Number of previous therapies: one, 53%; two, 28%; three or more, 19%. In the intent-to-treat analysis at 1 year, 38 patients (44.7%) achieved viral load below 500 copies/mL. Adherence greater than 90% of prescribed drugs was reported in 49% of patients, adverse events were reported in 17.6%, mortality in 6%, and lost to follow-up in 26%. The factors associated with virologic failure were nonadherence (odds ratio [OR], 4.4; 95% CI 1.5-12.3), baseline CD4 cell count <200 cells/mL (OR, 3.4; 95% CI 1.3-8.9; p =.01), and more than one previous treatment (OR, 2.7; 95% CI 1.1-6.9). CONCLUSION: Regarding previously very nonadherent patients, this simplified combination therapy containing three NRTIs obtained satisfactory results in ART-experienced patients. However, more aggressive interventions to enhance adherence are needed to improve results.

[Erectile dysfunction after radial prostatectomy. Response to treatment with sildenafil citrate]. / Disfunción eréctil postprostatectomía radical. Respuesta al tratamiento con citrato de sildenafilo.

OBJECTIVES: Erectile dysfunction is one of the sequelae after radical prostatectomy most concerning for the patient, its appearance being influenced by factors such as surgical technique, or patient's age. Thus, around 40% of the patients younger than 70 years and over 90% of the patients older than 70 present with erectile dysfunction after prostatectomy. We studied the response to sildenafil citrate in patients who underwent non nerve sparing radical prostatectomy. METHODS: Medical records of 100 patients who underwent radical prostatectomy at our department between 1985 and 1998 were retrospectively reviewed and telephone interviews were done to investigate the degree of erectile dysfunction following surgery. All patients were offered to start a two-month therapeutic trial with sildenafil citrate, in dose escalation up to a maximum of 100 mg. Therapeutic response was evaluated by personal interviews. RESULTS: 5 out of 100 patients interviewed showed similar potency than preoperatively. Among 95 patients with erectile dysfunction 63 (66.3%) did not wish treatment for erectile dysfunction. 22 of the remainder 32 patients initiated treatment with sildenafil citrate, whereas 10 preferred trying intracavernous PGE1 injections only. In the intracavernous injections group 5 patients abandoned because of pain with injections and refused any further treatment with oral drugs; 5 patients are satisfied with intracavernous therapy and they do not want to try sildenafil. In the sildenafil group form 22 patients starting treatment 14 (63.6%) are satisfied, with a subjective improvement. Only 5 patients (22%) show an erectile response enough to have sexual intercourse with penetration. 8 (36.5%) abandon treatment because of lack of efficiency. CONCLUSIONS: 5% of the patients who undergo non nerve sparing radical prostatectomy maintain sexual potency without treatment postoperatively. Most patients with postoperative erectile dysfunction (63/95 = 66.3%) do not want any treatment. From 22 patients initiating treatment with sildenafil 5 can have sexual intercourse with penetration (5/22 = 22%), all of them with 100 mg doses of sildenafil.

Disfunción eréctil postprostatectomía radical. Respuesta al tratamiento con citrato de sildenafilo / Erectile dysfunction after radical prostatectomy. Results with sildenafil citrate treatment

OBJETIVOS: La disfunción eréctil es una de las secuelas que más preocupa a los pacientes sometidos a prostatectomía radical, dependiendo su aparición de diversos factores como la técnica empleada o la edad del paciente. Así, alrededor del 40 per cent de los pacientes menores de 70 años y más del 90 per cent de los mayores de 70 años presentan disfunción eréctil postprostatectomía. En este trabajo estudiamos la respuesta al sildenafilo de los pacientes sometidos a prostatectomía radical sin intento de conservación de nervios erectores. MÉTODOS: Se revisaron las historias clínicas de 100 pacientes sometidos a prostatectomía radical en nuestro servicio desde 1995 a 1998 y se les entrevistó telefónicamente con el fin de averiguar el grado de disfunción eréctil que siguió a la cirugía. A todos los pacientes se les propuso realizar un tratamiento de prueba con citrato de sildenafilo durante dos meses, a dosis creciente, hasta alcanzar la dosis máxima de 100 mg. La respuesta al tratamiento se evaluó mediante entrevista personal. RESULTADOS: De los 100 pacientes entrevistados, 5 presentaban una potencia sexual similar a la preoperatoria. De los 95 pacientes con disfunción eréctil postoperatoria, 63 (66,3 per cent) no deseaban tratamiento para su disfunción eréctil. De los 32 pacientes restantes 22 inician tratamiento con sildenafilo, mientras que 10 prefieren probar sólo PGE1 intracavernosa. De estos últimos, 5 presentan dolor importante a la inyección del producto y abandonan el tratamiento y cualquier intento de tratamiento ulterior por vía oral.5 están satisfechos con las inyecciones intracavernosas y no desean probar el sildenafilo. De los 22 que inician tratamiento con sildenafilo 14 (63,6 per cent) están satisfechos, con mejoría subjetiva. Sólo 5 pacientes (22 per cent) presentan una respuesta eréctil suficiente como para mantener relaciones sexuales con penetración. 8 (36,4 per cent) abandonan el tratamiento por ser ineficaz. CONCLUSIONES: Un 5 per cent de los pacientes sometidos a prostatectomía radical sin intento de conservar nervios erectores mantienen la potencia sexual postoperatoriamente sin tratamiento. La mayoría de los pacientes con disfunción eréctil postoperatoria (63/95=66,3 per cent), no desean ningún tratamiento. De los 22 pacientes que inician tratamiento con sildenafilo 5 consiguen mantener relaciones sexuales con penetración (5/22=22 per cent), todos ellos con dosis de 100 mg de sildenafilo (AU)

Problemática y soluciones actuales en el tratamiento de las infecciones por microorganismos grampositivos / Problems and current solutions for the treatment of infections caused by gram-positive microorganisms

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