RESUMO
Nevirapine (NVP), a non-nucleoside reverse transcriptase inhibitor, is a drug widely used in the treatment of Acquired Immunodeficiency Syndrome (AIDS). The evaluation of NVP stability is of fundamental importance in order to guarantee drug product efficacy, safety and quality. In this study, NVP active pharmaceutical ingredient (API) and tablets were subjected to a detailed study of forced degradation, employing several degrading agents (acid, alkaline, water, metal ions, humidity, heat, light and oxidation agents). In order to determine NVP and the degradation products formed, a stability-indicating UHPLC method using fused core column was developed and validated. The separation was carried out using a Poroshell 120C18 column (100×2.1mm i.d.; 2.7µm particle size) and the mobile phase was composed of acetonitrile and water in a gradient elution, at a flow rate of 0.2ml/min. Chemical structures and mechanisms for the formation of three degradation products were proposed by means of LC/MS-MS. Also, NVP degradation kinetic was studied and its order of degradation evaluated. NVP was degraded in acidic and oxidative conditions and the degradation profile for NVP tablets and API were similar. The stability-indicating method proved to be selective for NVP and its degradation products. Calibration curve was linear in the range of 8-48µg/ml and the method showed to be precise, accurate and robust for both NVP API and tablets, with detection and quantification limits of 0.092µg/ml and 0.174µg/ml, respectively.
Assuntos
Cromatografia Líquida de Alta Pressão/métodos , Nevirapina/análise , Inibidores da Transcriptase Reversa/análise , Espectrometria de Massas em Tandem/métodos , Calibragem , Contaminação de Medicamentos , Estabilidade de Medicamentos , Temperatura Alta , Umidade , Cinética , Nevirapina/química , Nevirapina/normas , Oxirredução , Reprodutibilidade dos Testes , Inibidores da Transcriptase Reversa/química , Inibidores da Transcriptase Reversa/normas , ComprimidosRESUMO
Testicular toxicity has been implicated in highly active anti-retroviral therapy (HAART) treatment. Hence there is need to identify an effective antioxidant product that can alleviate testicular necrosis due to HAART administration. Forty eight adult male Sprague-Dawley rats were used in this study. The animals were divided into eight (8) groups: A-H (n= 6). Group A animals received normal saline as the control; Group B was given Nevirapine (Nv); Group C was given Kolaviron (Kv); Group D was given vitamin C; Group E was given Nv and Kv; Group F was given Nv and Vitamin C; Group G was given Nv for 56 d and Kv for 28 d serving as a withdrawal group; Group H was given corn oil. Nv, Kv and Vit. C were given at 1.54, 200 and 250 (mg·kg)/bw respectively while all administrations were through oral gavage. The body weights were taken every other day. Thereafter, they were anaesthetized with halothane. The testes were excised, weighed, fixed in Bouin's fluid and stained with H&E while the epididymes removed for semen fluid analyses. The results showed a significant (P<0.05) decrease in sperm motility in group E (Nevirapine + kolaviron) when compared with group F (Nevirapine + Vitamin C) while Sperm count was not significantly different (P>0.05) across the groups. The testicular histoarchitectural studies revealed indistinct spermatogonia, necrotic interstititial endocrine cells in the altered interstitial space, fragmented spermatids, atrophy of mature spermatocytes, degenerated germ cells, obliterated seminiferous tubules lumen, undifferentiated spermatogonia and cellular debris in the somniferous tubules lumen of nevirapine administered group but normal across the other groups. In the testis, there were no significant reduction in SOD, Catalase and GPx activities but a significant decrease in GST activity (P<0.001) when group E was compared with group F. In conclusion, vitamin C presents a better remediation in nevirapine induced spermiotoxicity compared to kolaviron in Sprague-Dawley rats.
La toxicidad testicular ha sido implicada en la terapia antirretroviral altamente activa (TARAA). Por lo tanto existe la necesidad de identificar un producto antioxidante eficaz que pueda aliviar la necrosis testicular en la administración de la TARAA. Cuarenta y ocho ratas macho Sprague-Dawley adultas fueron utilizadas. Los animales se dividieron en ocho (8) grupos: AH (n= 6). Grupo A, animales recibieron solución salina normal como el control; Grupo B, recibió Nevirapina (Nv); Grupo C, recibió Kolaviron (Kv); Grupo D, recibió vitamina C; Grupo E, recibió Nv y Kv; Grupo F, recibió Nv y vitamina C; Grupo G, recibió Nv durante 56 d y Kv por 28 d como un grupo de retirada; Grupo H, recibió aceite de maíz. Nv, Kv y Vit. C se administraron en dosis de 1, 54, 200 y 250 (mg · kg) de peso corporal respectivamente; todas las administraciones fueron por sonda oral. Los pesos corporales se tomaron cada dos días. A partir de ese momento los animales fueron anestesiados con halotano. Los testículos fueron extirpados, pesados y fijados en solución de Bouin y teñidos con H&E, mientras que el epidídimo se retiró para analizar el semen. Los resultados mostraron un descenso (p<0,05) en la motilidad de los espermatozoides en el grupo E (Nevirapina + Kolaviron) en comparación con el grupo F (Nevirapina + vitamina C), mientras que el recuento espermático no mostró diferencias significativas (P>0,05) entre los grupos. El estudio de la histoarquitectura testicular reveló espermatogonias indiferenciadas, con células intersticiales necróticas en el espacio intersticial y espermátidas fragmentadas. Además, en el grupo que recibió Nevirapina mostró espermatocitos maduros atrofiados, degeneración de células germinales, lumen de los túbulos seminíferos obliterados, espermatogonias indiferenciadas y restos celulares en el lumen de los tubulos seminíferos. En el resto de los grupos los resultados fueron normales. En el testículo hubo una reducción significativa en las actividades de la superóxido dismutasa, catalasa y glutatión peroxidasa, pero una disminución significativa en la actividad glutatión S-transferasa (P <0,001) al comparar los grupo E y F.
Assuntos
Animais , Masculino , Ratos , Antioxidantes/farmacologia , Garcinia kola/química , Nevirapina/toxicidade , Extratos Vegetais/farmacologia , Superóxido Dismutase/antagonistas & inibidores , Testículo/efeitos dos fármacos , Fármacos Anti-HIV/toxicidade , Ácido Ascórbico/farmacologia , Biflavonoides/farmacologia , Peso Corporal , Catalase/antagonistas & inibidores , Glutationa Peroxidase/antagonistas & inibidores , Ratos Sprague-Dawley , Sementes , Contagem de Espermatozoides , Motilidade dos Espermatozoides/efeitos dos fármacos , Testículo/enzimologia , Testículo/patologiaRESUMO
Calibration transfer is commonly used for spectra obtained in different spectrometers or other conditions. This paper proposed the use of calibration transfer between spectra recorded for the same samples in different physical forms. A new method was developed for the direct determination of nevirapine in solid pharmaceutical formulations based on diffuse reflectance near infrared spectroscopy (NIRS) and partial least squares (PLS). This method was developed with 50 powder mixtures and then, successfully extended to the quantification in intact tablets by using calibration transfer with double window piecewise direct standardization (DWPDS). This chemometric strategy provided good results with a small number of tablet transfer samples, only seven, prepared out of the narrow range of active principle ingredients (API) content around the nominal value of the formulation (100%). The method was fully validated in the working range of 83.0-113.9% of nevirapine and the use of DWPDS allowed to significantly decreasing the root mean square error of prediction (RMSEP) from 4.8% (tablets predicted by a model built with only powder samples) to 2.6%. The range of relative errors decreased from -5.1/8.7% to -4.6/3.3%. Considering that the amount of raw materials demanded for preparing tablets is up to ten times higher than for powder mixtures, this type of application is of particular interest in pharmaceutical analysis. In the context of process analytical technology (PAT), the use of the same multivariate model in different steps of the production is very advantageous, saving time and labor.
Assuntos
Nevirapina/análise , Espectroscopia de Luz Próxima ao Infravermelho/métodos , Calibragem , Análise Multivariada , Nevirapina/química , Pós , ComprimidosRESUMO
OBJECTIVES: We describe nevirapine and efavirenz exposure on and off tuberculosis treatment and consequences for virological efficacy and tolerance in patients included in the ANRS 12146/12214-CARINEMO trial. METHODS: Participants were randomly selected to receive either nevirapine at 200 mg twice daily (n = 256) or efavirenz at 600 mg daily (n = 270), both combined with two nucleoside analogues. Blood samples were drawn 12 h after nevirapine or efavirenz administration, while on tuberculosis treatment and after tuberculosis treatment discontinuation. In 62 participants, samples taken 12 h after drug administration were drawn weekly for the first month of ART. Sixteen participants participated in an extensive pharmacokinetic study of nevirapine. Concentrations were compared with the therapeutic ranges of 3000-8000 ng/mL for nevirapine and 1000-4000 ng/mL for efavirenz. RESULTS: Nevirapine concentrations at the end of the first week of treatment (on antituberculosis drugs) did not differ from concentrations off tuberculosis treatment, but declined thereafter. Concentrations at steady-state were 4111 ng/mL at week 12 versus 6095 ng/mL at week 48 (P < 0.0001). Nevirapine concentrations <3000 ng/mL were found to be a risk factor for virological failure. Efavirenz concentrations were higher on than off tuberculosis treatment (2700 versus 2450 ng/mL, P < 0.0001). CONCLUSIONS: The omission of the 2 week lead-in dose of nevirapine prevented low concentrations at treatment initiation but did not prevent the risk of virological failure. Results support the WHO recommendation to use efavirenz at 600 mg daily in patients on rifampicin-based antituberculosis therapy.
Assuntos
Fármacos Anti-HIV/uso terapêutico , Terapia Antirretroviral de Alta Atividade/métodos , Benzoxazinas/uso terapêutico , Infecções por HIV/complicações , Infecções por HIV/tratamento farmacológico , Nevirapina/uso terapêutico , Tuberculose/complicações , Adulto , Alcinos , Antituberculosos/uso terapêutico , Ciclopropanos , Tolerância a Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Tuberculose/tratamento farmacológicoRESUMO
In this work, Nevirapine (NVP) was encapsulated within three derivatives of poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) (PEO-PPO-PEO) block copolymers (Tetronic(®) 904, 1107 and Pluronic(®) F127) with and without the addition of three pharmaceutical cosolvents (glycerin, propylene glycol and polyethylene glycol 400) over a wider range of concentrations (0-40% v/v). Also, we evaluated the effect of addition of the cosolvents on the micellar size as determined by dynamic light scattering (DLS) measurements and transmission electron microscopy (TEM). The solubilization capacity of the systems was investigated by UV-spectrophotometry (282nm) and the systems stability was evaluated for 1 month at 25°C. Finally, oral bioavailability of the NVP-loaded micellar systems (2mg/mL) was assessed in male Wistar rats (8mg/kg) and compared with a pediatric commercially available formulation (Viramune(®)). The present study demonstrates that PEO-PPO-PEO polymeric micelles were able to enhance apparent aqueous solubility of NVP with the addition of cosolvents. Moreover, micellar nanocarriers significantly (p<0.05) improved the oral bioavailability of the drug versus Viramune(®). Overall results support the suitability of the strategy toward the development of an optimized NVP aqueous formulation to prevent HIV/AIDS mother-to-child transmission.
Assuntos
Portadores de Fármacos , Micelas , Nevirapina/administração & dosagem , Nevirapina/farmacocinética , Inibidores da Transcriptase Reversa/farmacocinética , Administração Oral , Animais , Disponibilidade Biológica , Masculino , Microscopia Eletrônica de Transmissão , Ratos , Ratos Wistar , Inibidores da Transcriptase Reversa/administração & dosagem , Espectrofotometria UltravioletaRESUMO
In order to investigate the effects of two non-nucleoside reverse transcriptase inhibitors (NNRTIs) on the DNA damage in vivo, nevirapine (NVP; 3.3 mg/kg), efavirenz (EFV; 10 mg/kg) or saline were administered orally. Acute effects were analyzed 24 h after the administration of a single NNRTI dose, and subchronic effects 24 h after the last dose. Peripheral blood, brain, heart and liver samples were subjected to genotoxicity analyses and polychromatic erythrocytes from the bone marrow to micronucleus test. The micronucleus test did not reveal any significant differences between animals from the acute or subchronic groups. Comet assay showed that acute and subchronic NNRTI treatment did not cause any significant DNA damage in heart, liver or peripheral blood cells. However, increased damage indexes and frequencies were observed in the brain of mice, subchronically treated with EFV. This result suggests for the first time that this drug might induce genotoxicity in the brain.
Assuntos
Fármacos Anti-HIV/toxicidade , Benzoxazinas/toxicidade , Nevirapina/toxicidade , Inibidores da Transcriptase Reversa/toxicidade , Alcinos , Animais , Células da Medula Óssea/citologia , Encéfalo/citologia , Encéfalo/efeitos dos fármacos , Encéfalo/metabolismo , Ensaio Cometa , Ciclopropanos , Dano ao DNA , Eritrócitos/efeitos dos fármacos , Fígado/citologia , Masculino , Camundongos , Testes para Micronúcleos , Miocárdio/citologiaRESUMO
O presente trabalho se constitui de dois estudos clínicos realizados em Maputo, Moçambique, dos quais participaram 570 pacientes com infecção pelo HIV e tuberculose. Seus objetivos principais foram: a) determinar os parâmetros farmacocinéticos da rifampicina e da isoniazida na ausência e na presença da terapia antirretroviral (TARV) e b) comparar as concentrações plasmáticas da nevirapina e do efavirenz em vigência do tratamento para a tuberculose e após a sua descontinuação. Os dois estudos foram parte do ensaio clínicoANRS12146-CARINEMO, cujo objetivo foi comparar a eficácia e tolerância da terapia antirretroviral com base em nevirapina ou efavirenz quando coadministrada com a terapia padrão antituberculose. O tratamento para tuberculose foi composto por doses diárias de rifampicina e isoniazida, durante 6 meses, associadas a pirazinamida e etambutol nos dois primeiros meses. A TARV foi iniciada entre 4 e 6 semanas do tratamento para a tuberculose e os pacientes foram randomizados para receber nevirapina sem dose escalonada (200 mg duas vezes ao dia) ou efavirenz (600 mg dose única diária), ambos combinados com lamivudina e estavudina...
This work is composed of two clinical studies in Maputo, Mozambique, from which participated in 570 patients with co-infection with HIV and tuberculosis. Its main objectives were: a) determine the pharmacokinetic parameters of rifampicin and isoniazid in the absence and presence of antiretroviral therapy (ART) and b) compare the plasma concentrations of nevirapine and efavirenz in effectiveness of treatment for tuberculosis and after their discontinuation . The two studies were of the clínicoANRS12146-CARINEMO trial whose aim was to compare the efficacy and tolerability of antiretroviral therapy based on nevirapine or efavirenz when co-administered with the standard antituberculous therapy. The treatment for tuberculosis was composed of daily doses of rifampicin and isoniazid for 6 months, pyrazinamide and ethambutol associated with the first two months. The ART was initiated between 4 and 6 weeks of treatment for tuberculosis and patients were randomized to receive nevirapine without scaled dose (200 mg twice daily) or efavirenz (600 mg once daily), both in combination with lamivudine and stavudine...
Assuntos
Humanos , Infecções Oportunistas Relacionadas com a AIDS , HIV , Nevirapina , Rifampina , Tuberculose , Terapia Antirretroviral de Alta Atividade , Interações Medicamentosas , Vírus da Hepatite BRESUMO
Data regarding epidemiological aspects, antiretroviral drug safety, and outcomes of HIV-infected pregnant women and their newborns are limited in Argentina. We underwent a retrospective analysis of registries of HIV-infected pregnant women assisted at Helios Salud, Buenos Aires, Argentina (1997-2006). Variables associated with preterm delivery and neonatal complications were analyzed by univariate and logistic regression analyses. A total of 204 mother-child binomium were included. Maternal age (median): 29 years; 32.5% without prior diagnosis of HIV-infection. Baseline median CD4 T-cell count: 417 cell/μl; 98% received antiretroviral drugs during pregnancy [2 nucleoside analogs plus either nevirapine (55%) or a protease inhibitor (32%)]. Overall incidence of toxicity was 12.5%: rash (8%), anemia (3.5%) and hepatotoxicity (1%). Rash was associated with exposure to nevirapine. Eighty one percent and 50% reached HIV-viral loads <1000 and <50 copies/ml at the end of pregnancy, respectively. Twenty six percent had obstetric complications and 16% had preterm delivery. Of the newborns, 1.6% had congenital defects and 9% had neonatal complications. Overall neonatal mortality was 1% and perinatal transmission was 0.7%. Protease inhibitor use and obstetric complications were associated to preterm delivery while obstetric complications were associated with neonatal complications. In our population, hepatotoxicity was low despite frequent use of nevirapine. Protease inhibitor use was associated to preterm delivery. A favorable virological response and a low rate of perinatal transmission was observed, what supports the consensus that antiretroviral therapy benefits during pregnancy outweigh risks of maternal and neonatal adverse events.
La información sobre aspectos epidemiológicos, seguridad de drogas antirretrovirales y evolución de mujeres embarazadas HIV positivas y sus hijos es limitada en la Argentina. Realizamos un análisis retrospectivo de registros de embarazadas HIV positivas asistidas en Helios Salud, Buenos Aires, Argentina (1997-2006). Las variables asociadas con parto prematuro y complicaciones neonatales se estudiaron mediante análisis univariado y regresión logística. Estudiamos 204 binomios madre-hijo. Edad materna (mediana): 29 años, 32.5% sin diagnóstico previo de HIV. Recuento de linfocitos T CD4+ (mediana): 417 células/μl. El 98% recibió tratamiento antirretroviral durante el embarazo [dos análogos de nucleósidos más nevirapina (55%) o un inhibidor de proteasa (32%)]. La incidencia global de toxicidad fue 12.5%: erupción cutánea (8%), anemia (3.5%) y hepatotoxicidad (1%). La exposición a nevirapina se asoció con rash. El 81% y 50% alcanzaron cargas virales <1000 y <50 copias/ml preparto, respectivamente. Cesárea programada: 68%; complicaciones obstétricas: 26%; parto prematuro: 16%. De los neonatos, 1.6% presentaron defectos congénitos y el 9% complicaciones neonatales. La mortalidad neonatal fue 1% y la transmisión vertical: 0.7%. Las complicaciones obstétricas y el uso de inhibidores de proteasa se asociaron a parto prematuro; las complicaciones obstétricas se asociaron con complicaciones neonatales. La tasa de hepatotoxicidad fue baja a pesar de la utilización frecuente de nevirapina; el uso de inhibidores de proteasa se asoció a parto prematuro. Se observó una respuesta virológica favorable y una baja tasa de transmisión vertical, lo que apoya el consenso de que el beneficio de las drogas antirretrovirales durante el embarazo supera el riesgo de efectos adversos maternos y neonatales.
Assuntos
Adulto , Feminino , Humanos , Lactente , Recém-Nascido , Gravidez , Infecções por HIV/epidemiologia , Complicações Infecciosas na Gravidez/epidemiologia , Fármacos Anti-HIV/uso terapêutico , Terapia Antirretroviral de Alta Atividade/efeitos adversos , Terapia Antirretroviral de Alta Atividade/normas , Argentina/epidemiologia , Seguimentos , Infecções por HIV/tratamento farmacológico , Recém-Nascido Prematuro , Idade Materna , Nevirapina/uso terapêutico , Resultado da Gravidez , Complicações Infecciosas na Gravidez/tratamento farmacológico , Complicações Infecciosas na Gravidez/prevenção & controle , Análise de Regressão , Estudos Retrospectivos , Carga ViralRESUMO
El Virus de inmunodeficiencia humana (VIH), es un retrovirus que afecta la inmunidad celular mediante la unión selectiva a células que expresan la molécula CD4 en su superficie, en especial los linfocitos T. Descubierto en la década de los 80, ha cobrado la vida de 20 millones de personas hasta la actualidad, con un remanente de 37.8 millones que aún quedan como portadores. De esta última cifra, más de un 50 son niños infectados perinatalmente, con una tasa de 1.500 por día a nivel mundial23. Se han realizado varios trabajos en la última década (PACTG 076, PACTG 316, entre otros), para comprobar la eficacia de la zidovudina, sola y asociada a otros inhibidores de la transcriptasa. La falta de recursos en países como el nuestro imposibilita la implementación adecuada del esquema profiláctico de transmisión perinatal utilizado en países del primer mundo, por lo que debemos utilizar otras combinaciones terapéuticas aún en estudio. Para documentar la eficacia del esquema más utilizado en nuestro medio: biterapia estándar de lamivudina (3TC) y zidovudina (AZT), más la adición de una monodosis de nevirapina justo antes del parto, se realizó un estudio de cohorte, observacional, retrospectivo y comparativo en el hospital maternidad Mariana de Jesús, de la ciudad de Guayaquil, debido a su alta incidencia de casos11. El estudio abarcó madres VIH positivo con embarazos interrumpidos por cesárea durante el año 2004, así como también datos de sus neonatos. A fin de sustentar la eficacia de la terapia, se tomaron en consideración los valores de carga viral, obtenidos por PCR y contaje celular CD4, ambos realizados en los laboratorios del Instituto Nacional de Higiene Leopoldo Izquieta Pérez, de Guayaquil. Así como también, datos de laboratorio relevantes a los efectos secundarios que pudieran haber sido ocasionados por esta asociación terapéutica, en especial valores de hemoglobina para el seguimiento del efecto secundario más común de esta terapia que es la anemia.
Human immunodeficiency virus (VIH), is a retrovirus affecting cellular immunity through selective union to cells with CD4 molecule expression in their surfaces, especially T-lymphocytes. Discovered in the 80s, it has killed 20 million up to now, with a remnant of 37.8 million carriers. From the last figure, more than 50 are children infected in perinatal stage, with a world rate of 1,500 per day23. In the last decade several papers have been made (PACTG 076, PACTG 316, among others), to check the effectiveness of zidovuline, alone, and associated to other transcriptase inhibitors. Lack of resources in countries like ours makes impossible to carry out appropriately the preventive system of perinatal transmission used in the first world countries; therefore we have to use other therapy combinations which are still object of studies. To document the effectiveness of the most used system in our country: standard lamivudine (3TC) and zidovuline (AZT) bitherapy, plus a dose of neviparine just before labor, a cohort, observational, retrospective and comparative study was carried out in the maternity hospital Mariana de Jesús in Guayaquil because of its high case incidence11. The study included positive HIV mothers with interrupted pregnancies by cesarian section during 2004, as well as their newborn data. In order to uphold the effectiveness of the therapy, viral load values, obtained by PCR and cell count CD4 (both made in the Instituto Nacionalde Higiene Leopoldo Izquieta Pérez laboratories), were considered. Laboratory data related to side effects that could be produced by this combined therapy were also considered, especially hemoglobin values to make the follow up of the most common side effect: anemia.
Assuntos
Feminino , Gravidez , Recém-Nascido , Terapia Combinada , HIV-1 , Transmissão Vertical de Doenças Infecciosas , Fármacos Anti-HIVRESUMO
Nevirapine-based therapy is associated with increased frequency of adverse events among HIV-infected pregnant women. The aim of this article was to evaluate the incidence of adverse effects in HIV-infected women who started nevirapine during pregnancy. A retrospective study was performed in our center between January 2003 and December 2006 analyzing all women prescribed nevirapine during pregnancy. Women presenting any risk factor for hepatotoxicity were excluded from the analysis. Patients were divided into two groups according to the presence or absence of adverse effects, and a correlation to CD4 counts was performed. Liver function abnormality was graded according to the Division of AIDS toxicity guidelines. A total of 170 women initiated nevirapine during pregnancy, but only 133 were included in the study. Twenty-seven women (20.3 percent) presented adverse effects, skin rash accounting for 77.8 percent (21/27 women) and liver function abnormalities for 22.2 percent (6/27) of the cases. Baseline CD4 counts, viral loads and transaminases were similar in both groups. All nevirapine side effects were developed in less than seven weeks. Four of 31 women with CD4 counts <250 cells/µL (12.9 percent) and 23 of 102 women with CD4 counts ≥250 cells/µL (22.5 percent) developed adverse events. All patients who experienced hepatotoxicity had pretreatment CD4 counts >250cells/µL. The incidence of adverse events with nevirapine in our study was high, but most of them were cutaneous. There was no correlation between high CD4 counts and adverse events when analyzing both cutaneous and hepatic reactions; nevertheless, hepatotoxicity occurred only in pregnant women with CD4 counts ≥250cells/µL.
Assuntos
Adulto , Feminino , Humanos , Gravidez , Fármacos Anti-HIV/efeitos adversos , Doença Hepática Induzida por Substâncias e Drogas , Toxidermias/etiologia , Infecções por HIV/tratamento farmacológico , Nevirapina/efeitos adversos , Complicações Infecciosas na Gravidez/tratamento farmacológico , Fármacos Anti-HIV/uso terapêutico , Doença Hepática Induzida por Substâncias e Drogas , Toxidermias/diagnóstico , Nevirapina/uso terapêutico , Estudos Retrospectivos , Índice de Gravidade de Doença , Transaminases/sangue , Carga ViralRESUMO
La Necrólisis epidérmica tóxica (N.E.T), es un desorden poco frecuente, caracterizado por una muerte epidérmica extensa, producido por una reacción idiosincrática por drogas. Es una enfermedad grave que puede eventualmente ocasionar la muerte por complicaciones sépticas o fallo multiorgánico, en alrededor del 30 % de los pacientes. El caso clínico que se describe, se asocia con el uso de Nevirapine que es un fármaco antirretroviral inhibidor de la Transcriptasa inversa, no análogo de nucleosidos, esta droga se vincula a la aparición de N.E.T en el 1% de los tratamientos(AU)
Toxic epidermal necrolysis (TEN) is a very uncommon disorder, characterized by extensive epidermal death, produced by an idiosyncratic drug reaction. Is a severe disease that eventually can be lethal. Death may be caused by septic complications or multiorgan failure, in about 30% of patients. In this case report the disease is related to the use of Nevirapine. This antiretroviral drug is a nonnucleoside reverse transcriptase inhibitor that is supposed to cause TEN in 1% of the patients.(AU)