RESUMO
INTRODUCTION: Etravirine has become an alternative in HIV/HCV coinfected patients because of safety and lack of interactions with anti-HCV drugs. The aim of this study was to establish the risk of liver toxicity in HIV/HCV coinfected patients receiving etravirine in the clinical setting, according to the degree of liver fibrosis and different accompanying drugs. MATERIAL AND METHODS: Cohort study of 211 patients initiating etravirine as part of their antiretroviral regimen. HCV coinfection was defined as a positive RNA-HCV, whereas baseline liver fibrosis was assessed by transient elastography at baseline. Hepatotoxicity was defined as an increased AST/ALT, 5-fold higher over upper, normal limits for patients with normal baseline values, or 3.5-fold if altered at baseline. RESULTS: HCV coinfection was observed in 145 patients (69%) with a longer time of HIV infection and time on HAART than mono-infected patients, and a lower nadir (182 vs 227 cells/mL; p=0.02) and baseline CD4+ count (446 vs 552 cells/mL; p=0.02). Etravirine was used with two nucleoside analogues in 62%, with boosted darunavir in 17%, with raltegravir in 10%, and with darunavir plus raltegravir or maraviroc in 10% of patients without differences according to HCV serostatus. Transient elastography in 117 patients performed at etravirine initiation (median, 33 days) showed fibrosis 1 and fibrosis 4 in 37% and 24% of cases, and median stiffness value was 8.25 kPa (3.5-69). During an accumulated follow-up of 449.3 patient-years (median, 611 days), only one coinfected patient with fibrosis 4 (stiffness value, 50.1 kPa), receiving a rescue regimen including darunavir/r plus maraviroc plus two nucleoside analogues, developed a grade 3-4 of liver toxicity (0.5%). There were no other episodes of liver toxicity, as defined, and only 6 (3%) and 9 patients (4%) had a grade 1 and 2 of toxicity, respectively, in most cases related to HCV coinfection (6 and 6 cases). Moreover, HCV coinfection or advanced fibrosis was not associated to a higher risk of etravirine discontinuation (26% vs 21%; p=0.27, log-rank test) or virologic failure (9% vs 11%, p=0.56). CD4+ cell count increase was lower in HCV patients (+23 vs +86 at 6 month; p=0.02). CONCLUSIONS: Etravirine is safe in HIV/HCV coinfected patients, even in presence of moderate and advanced liver fibrosis and as part of different antiretroviral regimens.
RESUMO
Objetivo: Conocer la prevalencia del RNA-GBV-C en pacientes VIH positivos y determinar si existen diferencias entre VHG positivos y negativos en cuanto a situación inmunológica y afectación hepática. Métodos: Se determinó la presencia de RNA-GBV-C en el suero de 222 pacientes VIH positivos mediante una RT-PCR semi-automatizada. Se compararon los pacientes RNA-GBV-C positivos con los negativos en relación a una serie de parámetros clínicos y analíticos. La misma comparación se realizó de forma particular entre aquellos coinfectados con el VHC y GBV-C y los que sólo presentaban el GBV-C Resultados: La prevalencia del RNA-GBV-C fue del 28,8 por ciento. El virus hepatotropo más frecuente fue el VHC con el 71,6 por ciento de los casos. El 17 por ciento presentaban coinfección VHC y GBV-C y el 8,6 por ciento solo tenían el GBV-C. Los pacientes con RNA- GBV-C positivo tenían características clínicas y analíticas similares a los RNA-GBV-C negativos. Entre coinfectados VHC-GBV-C y los que presentaban el GBV-C como único virus se observó que el grupo de coinfectados presentó alteración de transaminasas y predominio de la transmisión parenteral como factor de riesgo para la infección VIH, frente al grupo GBV-C que presentó transaminasas normales y predominio de la transmisión sexual. No hubo diferencias entre ambos grupos en cuanto a la media de CD4 y cifras de RNAVIH. Conclusiones: La positividad del RNA-GBV-C en pacientes VIH no influye en la presencia de enfermedad hepática que viene determinada en estos pacientes por la frecuente coinfección con otros virus hepatotropos. Tampoco parece influir en la viremia del VIH ni en la cifra de CD4 (AU)
Objective: To study the prevalence of GBV-C-RNA in sera of HIV-infected patients and determine whether differences in immunological condition and hepatic disease exist between GBV-C positive and negative patients. Methods: The presence of GBV-C -RNA was determined in sera of 222 HIV-positive patients by semi-automated RT-PCR. A comparison of GBV-C-RNA positive and negative patients was made by studying a series of clinical and analytical parameters. This same comparison was made in particular between those coinfected with HCV and GBV-C and those who only presented GBV-C. Results: Prevalence of GBV-C-RNA was 28.8%. The most frequent hepatotropic virus was HCV, appearing in 71.6% of cases. Coinfection with HCV and HGV was present in 17% and 8.6% only had GBV-C. Patients positive for GBV-C-RNA showed clinical and analytical characteristics similar to those found in GBV-C-RNA negative patients. Among the HCV-GBV-C coinfected and those presenting HGV as the only virus it was observed that the coinfected group presented alterations in transaminases and predominance of parenteral transmission as a risk factor for HIV, whereas the GBV-C group presented normal transaminases and predominance of sexual transmission. No differences were perceived in mean CD4 and HIV-RNA values in both groups. Conclusions: Being positive for GBV-C in HIV-positive patients does not influence the presence of hepatic disease that in these patients is frequently accompanied by coinfection with other hepatotropic viruses. Moreover, it does not seem to influence the viremia of the HIV nor the CD4 cell counts (AU)
Assuntos
Pessoa de Meia-Idade , Adolescente , Adulto , Idoso , Masculino , Feminino , Humanos , Carga Viral , RNA Viral , Espanha , Prevalência , Linfócitos T CD4-Positivos , HIV-1 , Infecções por HIV , Infecções por Flaviviridae , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Transaminases , Hepatite Viral Humana , Vírus GB CRESUMO
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