Therapeutic effectiveness of biosimilar standard interferon versus pegylated interferon for chronic hepatitis C genotypes 2 or 3

BACKGROUND: Pegylated interferon (Peg-IFN) and standard interferon (IFN) play a significant role in the treatment of hepatitis C virus (HCV) infection. Biosimilar standard IFN is widely available in Brazil for the treatment of HCV infection genotypes 2 or 3, but its efficacy compared to Peg-IFN is unknown. OBJECTIVE: To compare the sustained virological response (SVR) rates following treatment with biosimilar standard IFN plus ribavirin (RBV) versus Peg-IFN plus RBV in patients with HCV genotypes 2 or 3 infection. METHODS: A retrospective cohort study was conducted in patients with HCV genotypes 2 or 3 infection treated with biosimilar standard IFN plus RBV or with Peg-IFN plus RBV. SVR rates of the two treatments were compared. RESULTS: From January 2005 to December 2010, 172 patients with a mean age of 44 +/- 9.3 years were included. There were eight (4.7%) patients with HCV genotype 2 infections. One hundred fourteen (66.3%) were treated with biosimilar standard IFN plus RBV, whist 58 (33.7%) patients were treated with Peg-IFN plus RBV. Between the two groups, there were no significant differences regarding age, gender, glucose level, platelet count, hepatic necroinflammatory grade, and hepatic fibrosis stage. Overall, 59.3% (102/172) patients had SVR. In patients treated with Peg-IFN plus RBV, 79.3% (46/58) had SVR compared to 49.1% (56/114) among those treated with biosimilar standard IFN plus RBV (p = 0.0001). CONCLUSION: In patients with HCV genotypes 2 or 3 infection, a higher SVR was observed in patients receiving Peg-IFN plus RBV related to patients treated with biosimilar standard IFN plus RBV.

Occult hepatitis B virus infection in immunocompromised patients

Occult hepatitis B infection is characterized by hepatitis B virus (HBV) DNA in the serum in the absence of hepatitis B surface antigen (HBsAg). We assessed occult HBV infection prevalence in two groups of immunocompromised patients (maintenance hemodialysis patients and HIV-positive patients) presenting HBsAg-negative and anti-HBc positive serological patterns, co-infected or not by HCV. Thirty-four hemodialysis anti-HIV negative patients, 159 HIV-positive patients and 150 blood donors who were anti-HBc positive (control group) were selected. HBV-DNA was detected by nested-PCR. Occult hepatitis B infection was not observed in the hemodialysis patients group but was found in 5 percent of the HIV-patients and in 4 percent of the blood donors. Immunosuppression in HIV positive patients was not a determining factor for occult HBV infection. In addition, no significant relationship between HBV-DNA and HCV co-infection in the HIV-positive patient group was found. A lack of significant associations was also observed between positivity for HBV-DNA and CD4 count, viral load and previous lamivudine treatment in these HIV-positive patients.

Weight-based combination therapy with peginterferon alpha-2b and ribavirin for Naïve, relapser and non-responder patients with chronic hepatitis C

Combination therapy with pegylated interferon and ribavirin is considered the new standard therapy for naïve patients with chronic hepatitis C. We evaluated the efficacy and safety of treatment with weight-based peginterferon alpha-2b (1.5 mg/kg per week) plus ribavirin (800-1,200 mg/day) for 48 weeks in naïve, relapser and non-responder (to previous treatment with interferon plus ribavirin) patients with chronic hepatitis C. Sixty-seven naïve, 26 relapser and 40 non-responder patients were enrolled. The overall sustained virological response (SVR) for the intention-to-treat population was 54 percent for naïve, 62 percent for relapser and 38 percent for non-responder patients. In the naïve subgroup, SVR was significantly higher in patients with the non-1 genotype (67 percent) compared to those with genotype 1 (45 percent). In relapsers and non-responders, SVR was, respectively, 69 percent and 24 percent in patients with genotype 1 and 43 percent and 73 percent in those with genotype non-1. There were no significant differences in SVR rates among the three body weight ranges (< 65 kg, 65-85 kg and > 85 kg) in any of the subgroups. Early virological response (EVR) was reached by 78 percent, 81 percent and 58 percent of naïve, relapser and non-responder patients, respectively, and among those with EVR, 63 percent, 67 percent and 61 percent, respectively, subsequently achieved SVR. All of the non-responder patients who did not have EVR reached SVR. Treatment was discontinued in 13 percent of the patients, due to loss to follow-up, hematological abnormalities or depression.

The influence of occult infection with hepatitis B virus on liver histology and response to interferon treatment in chronic hepatitis C patients

Occult hepatitis B virus (HBV) infections have been identified in patients with chronic hepatitis C virus (HCV) infection, although the clinical relevance of occult HBV infection remains controversial. We searched for serum HBV DNA in 106 HBsAg negative/anti-HBc positive patients with chronic HCV infection and in 150 blood donors HBsAg negative/anti-HBc positive/anti-HCV negative (control group) by nested-PCR. HCV genotyping was done in 98 patients and percutaneous needle liver biopsies were performed in 59 patients. Fifty-two patients were treated for HCV infection with interferon alone (n=4) or combined with ribavirin (n=48) during one year. At the end and 24 weeks after stopping therapy, they were tested for HCV-RNA to evaluate the sustained virological response (SVR). Among the 106 HCV-positive patients, 15 (14 percent) were HBV-DNA positive and among the 150 HCV-negative blood donors, 6 (4 percent) were HBV-DNA positive. Liver biopsy gave a diagnosis of liver cirrhosis in 2/10 (20 percent) of the HBV-DNA positive patients and in 6/49 (12 percent) of the HBV-DNA negative patients. The degree of liver fibrosis and portal inflammation was similar in HCV-infected patients HBV-DNA, irrespective of HBV-DNA status. SVR was obtained in 37.5 percent of the HBV-DNA positive patients and in 20.5 percent of the HBV-DNA negative patients; this difference was not significant. In conclusion, these data suggested that occult HBV infection, which occurs at a relatively high frequency among Brazilian HCV-infected patients, was not associated with more severe grades of inflammation, liver fibrosis or cirrhosis development and did not affect the SVR rates when the patients were treated with interferon or with interferon plus ribavirin.

Viral hepatitis in patients infected with human immunodeficiency virus

From 1992 to 1995 we studied 232 (69 percent male, 87 percent Caucasian) anti-human immunodeficiency virus (anti-HIV) positive Brazilian patients, through a questionnaire; HIV had been acquired sexually by 50 percent, from blood by 32 percent, sexually and/or from blood by 16.4 percent and by an unknown route by 1.7 percent. Intravenous drug use was reported by 29 percent; it was the most important risk factor for HIV transmission. The alanine aminotransferase quotient (qALT) was >1 for 40 percent of the patients, 93.6 percent had anti-hepatitis A virus antibody, 5.3 percent presented hepatitis B surface antigen, 44 percent were anti-hepatitis B core antigen positive and 53.8 percent were anti-hepatitis C virus (anti-HCV) positive. The anti-HCV test showed a significant association with qALT>1. Patients for whom the probable HIV transmission route was blood had a 10.8 times greater risk of being anti-HCV positive than patients infected by other routes. Among 30 patients submitted to liver biopsy, 18 presented chronic hepatitis

A clinical, epidemological, laboratorial, histological and ultrasonographical evaluation of anti-HCV EIA-2 positive blood donors

Between 1992 and 1997, 790 blood donors with anti-HCV EIA-2 strongly reagent (relationship between the sample optical density/cut-off > 3) detected at the blood bank serological screening, were evaluated in ambulatory environment. They were all negative for Chagas disease, syphilis, hepatitis B (HBsAg) and AIDS. Blood samples were collected at the first ambulatorial evaluation, for hemogram, biochemical tests and new serological tests for HCV (anti-HCV EIA-2). In blood samples of 226 repeatedly reagent anti-HCV EIA-2 blood donors, supplementary "immunoblot" test for HCV (RIBA-2) was used. In 209 donors, the presence of HCV-RNA was investigated by the PCR test. The abdominal ultrasonography was realized in 366 donors. In 269 patients liver biopsy was performed for the histopathological study. The follow-up of blood donors showed that 95.6 percent were repeatedly EIA-2 reagent, 94 percent were symptomless and denied any hepatitis history, with only 2 percent mentioning previous jaundice. In 47 percent of this population at least one risk factor has been detected for the HCV transmission, the use of intravenous drugs being the main one (27.8 percent). Blood transfusion was the second factor for HCV transmission (27.2 percent). Hepatomegaly was detected in 54 percent of the cases. Splenomegaly and signs of portal hypertension have seldom been found in the physical examination, indicating a low degree of hepatic compromising in HCV. Abdominal ultrasound showed alterations in 65 percent of the subjects, being the steatosis the most frequent (50 percent). In 83.5 percent of the donors submitted to the liver biopsy, the histopathological exam showed the presence of chronic hepatitis, usually classified as active (89 percent) with mild or moderate grade in most of the cases (99.5 percent). The histopathological exam of the liver was normal in 1.5 percent of blood donors. The RIBA-2 test and the HCV-RNA investigation by PCR were positive in respectively 91.6 and 75 percent of the anti-HCV EIA-2 reagent donors. The HCV-RNA research was positive in 82 percent of the RIBA-2 positive subjects, in 37.5 percent of the indeterminate RIBA-2 donors and in 9 percent of the negative RIBA-2 donors. Chronic hepatitis has also been observed in 50 percent of the histopathological exams of the anti-HCV EIA-2 reagent donors which were indeterminate RIBA-2...

Hepatitis C virus in monozygotic twins

A case of a pregnant patient with chronic hepatitis C who gave birth to monozygotic twins that were infected with HCV is reported. One of the newborns was positive for HCV-RNA in blood sample collected 12 hours after delivery. The other newborn was negative for HCV-RNA at birth, but was detected HCV viremia at three months of age. The results have led to the conclusion that one of the twins was probably contaminated in the intrauterine period, while the other acquired the infection in the perinatal period. Both were negative for HCV-RNA and for anti-HCV in the serum samples collected at nine months of age. The report describes the changes in the laboratory tests conducted in mother and twins until 29 months after delivery.

Transfusion-transmited virus (TTV) in Brazil: preliminary report

TTV e um virus DNA recentemente descoberto no Japao a partir de um paciente portador de hepatite pos-transfusional de origem desconhecida. Neste estudo, avaliamos a presenca deste virus em pacientes com hepatopatias cronicas dos estados de Sao Paulo e do Para, representando duas regioes geograficamente diferentes. O DNA do TTV foi encontrado em 21/105 (20 por cento) e 9/20 (45 por cento) dos casos de Sao Paulo e do Para, respectivamente. O sequenciamento do DNA amplificado confirmou a presenca dos genotipos 1a e 2a, bem como de outros genotipos ainda nao descritos ate o momento. Em conclusao, TTV esta presente em casos de hepatopatias cronicas do Sudeste e do Norte do Brasil. por outro lado, maiores estudos ainda sao necessarios antes de se estabelecer relacao causal entre o TTV e a hepatite em seres humanos

Elevated alanine aminotransferase (ALT) in blood donors: an assessment of the main associated conditions and its relationship to the development of hepatitis C

A determinacao dos niveis de alanina aminotransferase (ALT) tem sido util para o diagnostico de hepatopatias. Ultimamente, a elevacao dos niveis sericos de ALT em doadores de sangue, tem sido associada a um maior risco de hepatites pos-tranfusionais. Este estudo busca identificar os fatores associados com elevados niveis de ALT entre doadores voluntarios de sangue e avaliar as relacoes entre estes aumentos de ALT e o desenvolvimento de infeccao pelo virus da hepatite C. Assim, 116 doadores voluntarios de sangue com niveis de ALT elevados, quando da primeira doacao, foram estudados. Todos foram questionados sobre hepatopatias previas, exposicao a hepatites, exposicao a produtos quimicos, uso de drogas ou medicamentos, comportamento sexual, contacto com sangue ou secrecoes e consumo de alcool...

Prevalence of HIV and Treponema pallidum infections in pregnant women in Campinas and their association with socio-demographic factors

The anonymous seroprevalence of HIV and syphilis was studied by collecting umbilical cord blood samples from 5,815 women who gave birth in Campinas'hospitals throughout a six-month period. ELISA and Western blot were used for HIV, and VDRL and TPHA for Treponema pallidum screening. While maintaining the anonymity of the women, information was recorded on the hospital of origin, divided into university (public) and private hospitals, as well as on the form of payment (social security, private insurance or direct payment), age, marital status, education, employment and place of residence. Seroprevalence was 0.42 percent for HIV and 1.16 percent for syphilis. There was a significant correlation between a positive reaction to the two infections (p=0.02). After univariate and logistic regression analysis, only university hospitals were shown to be associated with seropositivity for HIV, whereas the same variable and an older age were associated with syphilis. All positive reactions were found either in public hospitals or among social security patients treated at private institutions. The conclusion was that HIV infection is becoming almost as prevalent as syphilis among this population, and affects primarily the lower socio-economic strata. This suggests that routine, voluntary HIV serology should be considered and discussed with patients during prenatal or delivery care whenever a population shows a seroprevalence close to or greater than 1 percent.

Hepatites pós-transfusionais na cidade de Campinas, SP, Brasil. II. Presença dos anticorpos anti-HBc e anti-HCV em candidatos a doadores de sangue e ocorrência de hepatites pós-transfusionais pelo vírus C nos receptores de sangue ou derivados / Post-transfusional hepatitis in the city of Campinas, SP, Brazil. II. Presence of anti-HBc and anti-HCV antibodies in blood donor candidates and occurrence of post-transfusional hepatitis C in recipients of blood or derivates

We have analysed anti-HBc and anti-HCV antibodies in serum samples from 799 donors which had their blood or derivates transfused to 111 recipients. Anti-HBc and anti-HCV were reactive in respectively 9 and 2.1 of the donors tested. We have observed that among the 111 recipients, 44 had received at least one positive anti-HBc unit and 67 had been transfused only with negative anti-HBc, units. The risk of developing hepatitis C virus was 4.5 times higher for the recipients who received at least one positive anti-HBc unit. If the test for anti-HBc had been made for the blood donors in the serological screening, about 56 of the HCV cases in the recipients could have been avoided. The population of recipients who received at least one reacting unit of anti-HCV, presented a risk 29 times higher of developing this hepatitis, as compared to the transfused recipients with all anti-HCV negative units. Testing blood from donors for anti-HCV would avoid 79 of the post-transfusional HCV cases. Brazilian candidates to blood donors seem to be carriers either simultaneously or sequentially to hepatitis virus B and C, since 44.4 of the positive anti-HCV were also positive for anti-HBc. Testing for anti-HBc and anti-HCV in blood screening must be indicated in order to prevent post-transfusional hepatitis transmission in our community.