Clinical and epidemiology evaluation of Aids-infected patients hospitalized between 2011 and 2016 in the Santos region of Brazil.

INTRODUCTION: We assessed the clinical-epidemiological profile of acquired immune deficiency syndrome (AIDS) patients in the Santos region (São Paulo state) with the highest AIDS prevalence in Brazil. METHODS: Information was extracted from records of 409 AIDS-infected patients hospitalized between 2011 and 2016. RESULTS: Human immunodeficiency virus (HIV) was diagnosed in 24.7% of patients during admission, and 39.6% of already diagnosed patients received highly active antiretroviral therapy (HAART) irregularly. The mortality rate was 19.1%, and the main secondary manifestations were neurotoxoplasmosis and tuberculosis. CONCLUSIONS: AIDS patients in the Santos region had high rates of late diagnosis and low treatment adherence.

Clinical and epidemiology evaluation of Aids-infected patients hospitalized between 2011 and 2016 in the Santos region of Brazil

Abstract INTRODUCTION: We assessed the clinical-epidemiological profile of acquired immune deficiency syndrome (AIDS) patients in the Santos region (São Paulo state) with the highest AIDS prevalence in Brazil. METHODS Information was extracted from records of 409 AIDS-infected patients hospitalized between 2011 and 2016. RESULTS: Human immunodeficiency virus (HIV) was diagnosed in 24.7% of patients during admission, and 39.6% of already diagnosed patients received highly active antiretroviral therapy (HAART) irregularly. The mortality rate was 19.1%, and the main secondary manifestations were neurotoxoplasmosis and tuberculosis. CONCLUSIONS: AIDS patients in the Santos region had high rates of late diagnosis and low treatment adherence.

Management of hepatitis C infection with direct action antiviral drugs (DAA)

Several new direct action antiviral drugs (DAA) against the HCV virus (HCV) are approved and marketed. The combination of DAA with pegylated interferon and ribavirin (PR) is only recommended to patients with tolerance to interferon (IFN). IFN-free treatments are now considered elective drugs for patients with chronic HCV. More than 90% of patients infected with HCV genotype 1 or 4 (fewer with other genotypes) show sustained virological response, when treated with sofosbuvir combined with simeprevir, daclatasvir or ledipasvir, or by the combination of paritaprevir with ritonavir, ombitasvir and dasabuvir, with or without ribavirin. The safety and efficacy of DAA therapy in HIV-HCV confection is now comparable with HCV monoinfection. DAA drugs are also efficient in patients with previous interferon/ribavirin, or protease inhibitors, treated patients as well as with hepatic transplanted patients. The goal of this review is to clarify the current stage of DAA drugs already approved and available by January-2016. Another objective is to discuss the main drugs regimen recommended by international medical associations and drugs regulatory agencies, including Brazil's Health Ministry. In this review, the authors make an approach about: adverse effects of DAA; interactions with other drugs, efficacy in patients with compensated cirrhosis or comorbidities, different genotypes or subtypes, as well as the development of resistance associated to viral mutants and their possible clinical importance

Low-density lipoprotein and other predictors of response with telaprevir-based therapy in treatment-experienced HCV genotype 1 patients: REALIZE study

BACKGROUND & AIMS: Predictors of response to treatment with peginterferon plus ribavirin are well established. In these post-hoc analyses of the REALIZE study, we sought to identify predictors of response for telaprevir-based triple therapy. METHODS: Patients from the REALIZE study with baseline data for all predictors evaluated (including baseline disease characteristics and demographics, prior treatment response and baseline laboratory assessments) were included in the post-hoc analyses (n = 465). Univariate and multivariate analyses were used to evaluate factors predicting treatment outcomes. RESULTS: Sustained viral response (SVR) rates were 86% in prior relapsers, 63% in prior partial responders and 32% in prior null-responders. In the final multivariate analysis, baseline factors predicting SVR were prior response to treatment [Odds ratio (OR) = 2.80; 95% confidence interval (CI), 2.13-3.69], low-density lipoprotein (LDL) (≥2.6 mmol/L) (OR = 2.11; 95% CI, 1.52-2.93), HCV genotype (OR = 0.58; 95% CI, 0.36-0.93), and maximum alanine amino transferase and aspartate amino transferase (OR = 0.62; 95% CI, 0.40-0.97). CONCLUSIONS: Prior response to peginterferon plus ribavirin treatment and LDL levels are the main independent predictive markers of response with telaprevir-based triple therapy

Low-density lipoprotein and other predictors of response with telaprevir-based therapy in treatment-experienced HCV genotype 1 patients: REALIZE study.

BACKGROUND & AIMS: Predictors of response to treatment with peginterferon plus ribavirin are well established. In these post-hoc analyses of the REALIZE study, we sought to identify predictors of response for telaprevir-based triple therapy. METHODS: Patients from the REALIZE study with baseline data for all predictors evaluated (including baseline disease characteristics and demographics, prior treatment response and baseline laboratory assessments) were included in the post-hoc analyses (n = 465). Univariate and multivariate analyses were used to evaluate factors predicting treatment outcomes. RESULTS: Sustained viral response (SVR) rates were 86% in prior relapsers, 63% in prior partial responders and 32% in prior null-responders. In the final multivariate analysis, baseline factors predicting SVR were prior response to treatment [Odds ratio (OR) = 2.80; 95% confidence interval (CI), 2.13-3.69], low-density lipoprotein (LDL) (≥2.6 mmol/L) (OR = 2.11; 95% CI, 1.52-2.93), HCV genotype (OR = 0.58; 95% CI, 0.36-0.93), and maximum alanine amino transferase and aspartate amino transferase (OR = 0.62; 95% CI, 0.40-0.97). CONCLUSIONS: Prior response to peginterferon plus ribavirin treatment and LDL levels are the main independent predictive markers of response with telaprevir-based triple therapy.

Response predictors and clinical benefits of hepatitis C retreatment with pegylated interferon and ribavirin in HIV/HCV coinfection.

BACKGROUND: Hepatitis C is a leading cause of mortality among HIV-infected individuals. Therefore, eradication of HCV in this population is a priority. There are scarce data regarding retreatment efficacy of HIV/ HCV coinfected patients. The aim of our study was to evaluate efficacy, predictors of response, and long term clinical benefits of sustained virological response (SVR) after hepatitis C retreatment in a population of HIV/HCV coinfected patients. MATERIAL AND METHODS: We evaluated efficacy, safety, and clinical benefits of peginterferon(alfa-2a or alfa-2b) and ribavirin in a restrospective, observational, multicentric study, including 47 HIV/HCV coinfected patients, non-responders to previous treatment with conventional interferon alfa-2a and ribavirin. The primary endpoint of efficacy was SVR, defined as undetectable viral load 24 weeks after end of treatment. Death, liver disease progression, CD4 counts, and AIDS defining illness were the endpoints to access clinical benefits of treatment response. RESULTS: In our analysis, 31.9% patients reached SVR. Genotypes 2/3 had a significant better SVR (66.7%) compared to genotypes 1/4 (33.3%) (p = 0.022). During follow-up, deaths (6.89%) and hepatic decompensation (28.6%) occurred only in the nonresponder group, while there were no cases of death or hepatic decompensation among the responder group(p = 0.037). CONCLUSION: Nearly one third of patients (mainly those with genotypes 2/3) reached SVR after hepatitis C retreatment in this group of HIV/HCV coinfected patients. SVR was protective against hepatic decompensation and death in a two-year follow-up period. Retreatment may be an effective and safe way to eradicate HCV until new anti-HCV drugs become available to this group of patients.

Limited impact of IL28B genotype on response rates in telaprevir-treated patients with prior treatment failure.

BACKGROUND & AIMS: Nucleotide polymorphisms upstream of the interleukin 28B (IL28B) gene are strongly associated with hepatitis C virus (HCV) clearance in treatment-naïve patients treated with peginterferon/ribavirin (PegIFN/RBV). This subanalysis of the REALIZE study evaluated the impact of IL28B polymorphisms on sustained virologic response (SVR) in telaprevir-treated, HCV genotype 1-infected patients with prior PegIFN/RBV treatment failure. METHODS: Treatment-experienced patients were randomized to 12 weeks of telaprevir (750 mg every 8h) with/without a 4-week PegIFN/RBV lead-in, or placebo, each with PegIFN-α-2a (180 µg/week) and ribavirin (1000-1200 mg/day) for 48 weeks overall. Data from telaprevir arms were pooled. RESULTS: Eighty percent (527/662) of patients consented to genetic testing and were included. Similar proportions of patients had IL28B CC, CT and TT genotypes across treatment arms; baseline characteristics were generally well balanced. SVR rates were higher in the pooled telaprevir versus placebo group for all IL28B genotypes; CC: 79% versus 29%, respectively; CT: 60% versus 16%, respectively; TT: 61% versus 13%, respectively. Within each prior response category (relapse, partial or null response), SVR and viral breakthrough rates with telaprevir-based treatment were comparable across IL28B genotypes. IL28B genotype did not significantly affect SVR (2-step multivariate analyses; p >0.16 in pairwise comparison among CC, TT, and CT). Variations in rapid virologic response and relapse rates were noted in certain patient subgroups. CONCLUSIONS: Our findings suggest that IL28B genotype has a limited impact on SVR rates with telaprevir-based therapy in treatment-experienced patients. IL28B genotyping may have limited utility in the baseline evaluation of similar patients considered for telaprevir-based therapy.

Homeostasis model assessment of insulin resistance does not seem to predict response to telaprevir in chronic hepatitis C in the REALIZE trial.

UNLABELLED: Baseline homeostasis model assessment-estimated insulin resistance (HOMA-IR), a marker for insulin resistance, has been associated with poor virologic response to peginterferon alpha/ribavirin (PR) in chronic hepatitis C. We evaluated the association between baseline HOMA-IR and pretreatment factors on sustained virologic response (SVR) to telaprevir (TVR) in genotype 1 patients with hepatitis C and prior peginterferon/ribavirin (PR) treatment failure. Patients were randomized to 12 weeks of TVR (750 mg q8h) plus peginterferon (180 µg/week) and ribavirin (1,000-1,200 mg/day) (with or without a 4-week lead-in) followed by PR, or PR alone (PR48), for 48 weeks. Univariate and multiple logistic regression analyses explored the prognostic significance of baseline HOMA-IR alone and adjusted for other pretreatment factors and SVR. The TVR arms were pooled for the purposes of this analysis. In all, 662 patients were randomized; 578 had baseline HOMA-IR and other prognostic data and were included in this analysis. Median baseline HOMA-IR was 2.6 (interquartile range [IQR] 1.7-4.3); 207 (36%), 206 (36%), and 165 (29%) patients had baseline HOMA-IR <2, 2 to <4, and ≥ 4, respectively. Male gender, higher body mass index, triglycerides, gamma-glutamyl transpeptidase, maximum alanine aminotransferase/aspartate aminotransferase, and fibrosis stage were associated with higher baseline HOMA-IR. Baseline HOMA-IR was associated with SVR in univariate analysis, but not after adjustment for other baseline prognostic factors (TVR: OR = 0.95, 95% confidence interval [CI]: 0.71,1.29; PR48: 0.60; 95% CI: 0.25,1.43). CONCLUSION: In patients with prior PR treatment failure, baseline HOMA-IR correlated with SVR in univariate but not multivariate analyses, suggesting other factors have a more direct causal relationship with virologic response to TVR-based therapy than HOMA-IR.

Telaprevir for retreatment of HCV infection.

BACKGROUND: Up to 60% of patients with hepatitis C virus (HCV) genotype 1 infection do not have a sustained virologic response to therapy with peginterferon alfa plus ribavirin. METHODS: In this randomized, phase 3 trial, we evaluated the addition of telaprevir to peginterferon alfa-2a plus ribavirin in patients with HCV genotype 1 infection who had no response or a partial response to previous therapy or who had a relapse after an initial response. A total of 663 patients were assigned to one of three groups: the T12PR48 group, which received telaprevir for 12 weeks and peginterferon plus ribavirin for a total of 48 weeks; the lead-in T12PR48 group, which received 4 weeks of peginterferon plus ribavirin followed by 12 weeks of telaprevir and peginterferon plus ribavirin for a total of 48 weeks; and the control group (PR48), which received peginterferon plus ribavirin for 48 weeks. The primary end point was the rate of sustained virologic response, which was defined as undetectable HCV RNA 24 weeks after the last planned dose of a study drug. RESULTS: Rates of sustained virologic response were significantly higher in the two telaprevir groups than in the control group among patients who had a previous relapse (83% in the T12PR48 group, 88% in the lead-in T12PR48 group, and 24% in the PR48 group), a partial response (59%, 54%, and 15%, respectively), and no response (29%, 33%, and 5%, respectively) (P<0.001 for all comparisons). Grade 3 adverse events (mainly anemia, neutropenia, and leukopenia) were more frequent in the telaprevir groups than in the control group (37% vs. 22%). CONCLUSIONS: Telaprevir combined with peginterferon plus ribavirin significantly improved rates of sustained virologic response in patients with previously treated HCV infection, regardless of whether there was a lead-in phase. (Funded by Tibotec and Vertex Pharmaceuticals; REALIZE ClinicalTrials.gov number, NCT00703118.).

Kikuchi-Fujimoto disease: an unusual association with acute renal failure

Kikuchi-Fujimoto disease, also known as histiocytic necrotizing lymphadenitis of unknown etiopathogenesis, is a self-limited disease which frequently appears as feverish lymphadenomegaly, thus creating the need for differential diagnosis with lymphoma, systemic lupus erythematosus (SLE), infectious mononucleosis, cat-scratch disease, and toxoplasmosis with lymphonodal impairment. However, there are cases in which it may evolve with complications such as aseptic meningitis, cerebellar ataxia, and aseptic myocarditis. We are presenting a case of a 24-year-old man who had an initial picture of arthralgia, evening fever and adenomegaly. Kikuchi disease was diagnosed through lymph node biopsy with immunohistochemistry and evolves with severe systemic manifestations, such as pericarditis with cardiac tamponade, pneumonitis, hepatitis, and acute kidney failure - the latter has not been reported in literature yet. There was significant improvement of the clinical picture with prednisone.

Survey of hepatitis B and C infection control: procedures at manicure and pedicure facilities in São Paulo, Brazil

Bleeding due to the habit of removing the cuticles of the finger and toes nails, without appropriate sterilization of instruments can be an important factor of contamination by hepatitis B and C viruses. The objectives of this study were to verify the use of standards on biosafety in the routine work of manicurists and/or pedicurists located in São Paulo, Brazil; know the level of information they have about ways of transmission and prevention of hepatitis B and C; evaluate the degree of risk perception for accidental exposure to infectious agents; and to estimate the prevalence of serological markers of hepatitis B and C among them. This was descriptive, cross-sectional study that included a random sample of 100 manicurists and/or pedicurists working in beauty salons. We administered a questionnaire to obtain personal information about the characteristics of the participants, collected blood for hepatitis B and C serology and assessed the working environment. Adherence to the professional standards on biosafety has been inadequate, and we noted that only 5 percent used disposable gloves, none washed their hands, 93 percent did not previously cleaned their working material and only 7 percent used disposable materials. A low level of knowledge about the routes of transmission, prevention, standards of biosafety, and risk perception of the infectious agents in their professional activity was observed. One out of ten interviewed manicurist and/or pedicurist had serological markers of hepatitis B or C, with 8 percent of hepatitis B and 2 percent of hepatitis C.

Survey of hepatitis B and C infection control: procedures at manicure and pedicure facilities in São Paulo, Brazil.

Bleeding due to the habit of removing the cuticles of the finger and toes nails, without appropriate sterilization of instruments can be an important factor of contamination by hepatitis B and C viruses. The objectives of this study were to verify the use of standards on biosafety in the routine work of manicurists and/or pedicurists located in São Paulo, Brazil; know the level of information they have about ways of transmission and prevention of hepatitis B and C; evaluate the degree of risk perception for accidental exposure to infectious agents; and to estimate the prevalence of serological markers of hepatitis B and C among them. This was descriptive, cross-sectional study that included a random sample of 100 manicurists and/or pedicurists working in beauty salons. We administered a questionnaire to obtain personal information about the characteristics of the participants, collected blood for hepatitis B and C serology and assessed the working environment. Adherence to the professional standards on biosafety has been inadequate, and we noted that only 5% used disposable gloves, none washed their hands, 93% did not previously cleaned their working material and only 7% used disposable materials. A low level of knowledge about the routes of transmission, prevention, standards of biosafety, and risk perception of the infectious agents in their professional activity was observed. One out of ten interviewed manicurist and/or pedicurist had serological markers of hepatitis B or C, with 8% of hepatitis B and 2% of hepatitis C.