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M Angelico

Publications and source records attributed to M Angelico.

At least 19 recordsLinked to original sources
PubMed2006

Extended double-dosage HBV vaccination after liver transplantation is ineffective, in the absence of lamivudine and prior wash-out of human Hepatitis B immunoglobulins.

BACKGROUND: The recommended prophylaxis against hepatitis B virus recurrence after liver transplantation based on hepatitis B immunoglobulins and lamivudine is highly expensive. A recent study reported a significant anti-HBs (antibodies against hepatitis B surface antigen) response after a reinforced vaccination against hepatitis B virus, a result not confirmed in a study from our group. Concomitant lamivudine treatment and the achievement of complete washout of anti-hepatitis B-specific immunoglobulin prior to vaccination in our study could explain the contradiction. AIMS: To test the efficacy of a reinforced anti-hepatitis B virus vaccination schedule without lamivudine and without previous anti-hepatitis B-specific immunoglobulin washout. METHODS: A double reinforced course of S-recombinant hepatitis B virus vaccination was given to seven male patients who were transplanted for hepatitis B virus-related cirrhosis. Vaccination consisted of two cycles of three intramuscular double doses (40 microg), given at month 0, 1, 2, and 3, 4, 5, respectively. The first dose was given 2 weeks after stopping lamivudine and the intravenous administration of anti-HBs immunoglobulins. The latter was continued throughout the study and follow-up period to maintain an anti-HBs titre >100 IU/L. RESULTS: At the end of both the first and the second vaccination cycle none of the patients developed an anti-HBs titre greater than the basal anti-HBs titre. CONCLUSION: These data confirm and expand our previous data on the lack of effectiveness of conventional recombinant hepatitis B virus vaccination in liver transplant recipients.

Adult↗
PubMed2005

Extended HBV vaccination in liver transplant recipients for HBV-related cirrhosis: report of two successful cases.

The effectiveness of hepatitis B virus vaccination in liver transplant recipients for hepatitis B virus-related end-stage liver disease is controversial. We report two successful cases, who developed sustained protection after long-term vaccination. Case 1. A 58-year-old male, transplanted 9 years earlier, received three intramuscular monthly doses of 40 microg of recombinant S vaccine and developed an anti-hepatitis B surface titre of 154 IU/L. After an additional 40 microg dose, he reached an anti-hepatitis B surface peak of 687 IU/L and then maintained a "protective" titre (>100 IU/L) without further vaccinations for the next 40 months. At this time, revaccination with three monthly doses of 40 microg resulted in an anti-hepatitis B surface titre greater than 25,000 IU/L, sustained over time. Case 2. A 56-year-old woman, transplanted 8 years earlier, first received three intramuscular monthly doses of 40 microg of S vaccine without developing any detectable anti-HBs. She was then given multiple intradermal vaccine doses which resulted in a titre of 37 IU/L. Next, after readministration of three 40 microg intramuscular monthly doses, she developed an anti-HBs titre of 280 IU/L. In the following 4 years, the anti-HBs titre dropped below 100 IU/L four times (at month 20, 30, 38 and 44) and readministration of single 40 microg doses of vaccine was always sufficient to restore a protective titre. Conclusion. Extended HBV vaccination may afford valid protection against HBV recurrence in selected liver transplant recipients.

Female↗
PubMed2005

Practice of adult liver transplantation in Italy. Recommendations of the Italian Association for the Study of the Liver (A.I.S.F.).

Liver transplantation is an efficient procedure as performed in Italy, yet major differences are present in terms of practice. In an effort to facilitate an homogeneous practice of liver transplantation in Italy, the Italian Association for the Study of Liver Disease has instituted a Commission aimed at providing recommendations on non-urgent liver transplantation in adults, based on current evidence. This nation-wide commission which included experienced hepatologists, surgeons and pathologists with major interest in liver transplantation has drafted a final document in October 2004, approved by the Italian Association for the Study of Liver Governing Board, whose key arguments and main conclusions are summarised in the present paper. The Commission has made specific recommendations on the following topics: the current needs of liver transplantation in Italy; the indications to liver transplantation and re-liver transplantation, with special reference to controversial issues and the minimal listing criteria; the use of marginal donors and the need to optimise donor/recipient matching; the use of living donor liver transplantation; the management of the waiting list and the introduction of Model for End-Stage Liver Disease to define priorities; the clinical management of liver transplantation recipients and disease recurrence; the implementation of audits and outcome monitoring; the training of transplant surgeons and hepatologists and the requirements for Centre accreditation; the pathology of liver transplantation.

Humans↗
PubMed2005

Amantadine monotherapy is ineffective in the treatment of hepatitis C virus recurrence in the post-liver transplantation setting.

BACKGROUND: Recurrent hepatitis C virus (HCV) infection is universal after liver transplantation (LT), yet no effective therapy is available. Amantadine (Am) is currently under evaluation. The aim of this study was to assess the safety and the effectiveness of Am monotherapy in LT patients with HCV recurrence. METHODS: Twelve patients who underwent transplantation 1-4 years earlier were included when there was detectable serum HCV-RNA and histological signs of liver damage with evidence of progressive hepatic fibrosis. Basal Ishak's scores were 2.1 +/- 1.3 and 5.1 +/- 2.7, respectively. Exclusion criteria were histological cirrhosis and comorbidities. All patients were receiving cyclosporine, with or without azathioprine. Amantadine was given orally (200 mg/d) for 3 months. RESULTS: Eight (67%) patients completed a 3-month treatment course without dose adjustments. Am was reduced to 100 mg/d in 3 cases and withdrawn in 1 due to side effects, namely, insomnia (n = 7; 58%), tremor (n = 4; 33%), headache (n = 2; 17%), asthenia (n = 2; 17%), and dermatitis, diarrhea, and increased creatinine (each n = 1; 8%). Serum HCV-RNA levels decreased in 3 patients, increased in 3, and remained unchanged in the others. Alanine aminotransferase (ALT) remained abnormal in all cases. Liver function test results did not improve. CONCLUSIONS: Short-term Am monotherapy was ineffective to treat post-LT HCV relapse and was associated with significant side effects.

Amantadine↗
PubMed2005

Molecular epidemiology of hepatitis C virus genotype 4 isolates in Egypt and analysis of the variability of envelope proteins E1 and E2 in patients with chronic hepatitis.

We analyzed hepatitis C virus (HCV) genotype 4 isolates circulating in the Alexandria District (Egypt) in terms of genetic divergence and the presence of different subtypes. Hypervariable region 1 (HVR1) and the NH2 region of the E2 protein were characterized, and the heterogeneity of subtype 4a isolates was evaluated by analyzing epitope frequencies, immunoproteasome prediction, and possible glycosylation patterns. The heterogeneity of the nucleotide sequences was greater than that found in previous studies, which reported only subtype 4a. Subtype 4a was most common (78% of cases), yet four new subtypes were found, with subtype 4m representing 11% of the cases and the other three subtypes representing another 11%. Substantial heterogeneity was also found when the intrasubtype 4a sequences were analyzed. Differences in the probability of glycosylation and in the positions of the different sites were also observed. The analysis of the predicted cytotoxic-T-lymphocyte epitopes showed differences in both the potential proteosome cleavage and the prediction score. The Egyptian isolates in our study also showed high variability in terms of the HVR1 neutralization epitope. Five of these isolates showed amino acid substitutions never previously observed (a total of six positions). Four of these residues (in four different isolates) were in positions involved in anchoring to the E2 glycoprotein core and in maintaining the HVR1 conformation. The results of this study indicate that HCV genotype 4 in Egypt is extremely variable, not only in terms of sequence, but also in terms of functional and immunological determinants. These data should be taken into account in planning the development of vaccine trials in Egypt.

Amino Acid Sequence↗
PubMed2004

Molecular characterisation of SENV and TTV infections in hepatopathic liver-transplant patients. Brief Report.

The presence of SENV and TTV infections among 50 patients who had undergone liver transplantation was evaluated. UTR amplification showed that 46 (92%) sera were positive. ORF-1 amplification showed that 25 (50%) patients were positive for either SENV (51.3%), TTV (10.8%), or both (37.8%) all confirmed by sequencing and phylogenetic analysis. SENV-D and SENV-H were the most prevalent viruses. The phylogenetic analysis of isolates showed that whereas SENV-D and SENV-G viruses showed sequence stability and strain persistence, SENV-H had cleared or mutated. Biological differences seem to exist among different genotypes in terms of viral replication and their persistence.

5' Untranslated Regions↗
PubMed2004

A randomized controlled trial of amantadine plus interferon-alpha2a vs. interferon-alpha2a alone in naive patients with chronic hepatitis C randomized according to the early virological response to interferon-alpha2a monotherapy.

BACKGROUND: An early virological response to interferon-alpha treatment is a strong predictor of sustained response, but it has never been exploited to stratify patients in clinical trials. AIM: To evaluate the efficacy of amantadine plus interferon-alpha compared with interferon-alpha alone in naive patients with chronic hepatitis C who were randomized on the basis of the early virological response to interferon-alpha. METHODS: One hundred and eighty-one patients received recombinant interferon-alpha2a (3 MU three times weekly) for 2 months and 164 were evaluated for early (i.e. month 2) virological response. Hepatitis C virus (HCV) RNA-negative patients (n = 66) were randomized to receive 3 MU of interferon-alpha three times weekly, with or without amantadine (200 mg/day); HCV RNA-positive patients (n = 98) were randomized to receive 6 MU of interferon-alpha three times weekly, with or without amantadine (200 mg/day). HCV RNA-positive patients at 6 months discontinued treatment, and all others completed 12 months. RESULTS: At month 6, HCV RNA-negative patients made up 54.2% of the interferon + amantadine group and 42.0% of the monotherapy group (P = 0.07). At month 12, HCV RNA-negative patients made up 38.5% of the interferon + amantadine group and 28.4% of the monotherapy group (N.S.). The sustained virological response rates were 21.6% and 20.9%, respectively (N.S.). CONCLUSION: The addition of amantadine does not enhance the sustained virological response to interferon-alpha in naive patients with chronic hepatitis C; however, an additive effect of amantadine occurs in the first 6 months, mainly in patients without an early response to monotherapy. Early response to interferon-alpha is a strong predictor of sustained virological response.

Adolescent↗
PubMed2003

13C-methacetin breath test for monitoring hepatic function in cirrhotic patients before and after liver transplantation.

BACKGROUND: In patients with chronic liver disease, the measurement of liver function is critical for monitoring disease progression, predicting the prognosis and choosing therapeutic strategies. The 13C-methacetin breath test is a simple, non-invasive diagnostic tool based on an inexpensive, non-toxic substance, which allows the accurate measurement of liver functional reserve. AIM: To investigate the 13C-methacetin breath test as a tool to monitor hepatic function in liver transplant candidates and recipients. METHODS: Twenty-eight cirrhotic patients listed for orthotopic liver transplantation and 10 healthy controls were studied. The 13C-methacetin breath test (75 mg per os) was performed at baseline and at 12-week intervals. Intra-operative measurements were obtained during the liver transplantation procedure in nine patients. Results were expressed as the 13C-methacetin cumulative oxidation percentage 45 min after substrate ingestion. RESULTS: The mean 13C-methacetin cumulative oxidation at 45 min was 16.4 +/- 3.5% in healthy controls and 5.4 +/- 4.2% in cirrhotic patients at the time of listing. In 11 patients who underwent successful liver transplantation, mean oxidation increased from 3.3 +/- 1.6% before transplantation to 17.0 +/- 5.2% at 6 months of follow-up. Variations in methacetine oxidation were closely related to the recovery of liver function. The mean intra-operative 13C-methacetin cumulative oxidation increased from 0.1% during the anhepatic phase to 3.7 +/- 2.0% 2 h after reperfusion. CONCLUSIONS: The 13C-methacetin breath test is a simple and potentially useful tool for monitoring hepatic function in cirrhotic patients listed for liver transplantation, and during the intra-operative and post-operative phases.

Acetamides↗
PubMed2002

Ribavirin increases mitogen- and antigen-induced expression of CD40L on CD4+ T cells in vivo.

Here, CD40L expression and cytokine production have been analysed in peripheral blood cells from orthotopic liver transplantation (OLT) recipients treated with ribavirin for recurrent chronic hepatitis C. The study included 18 OLT recipients treated with ribavirin, eight control OLT recipients and 10 healthy controls. FACS analysis showed that baseline expression of CD40L was not different between ribavirin-treated patients and controls. In contrast, after stimulation with both HCV core antigen and phorbol myristate acetate (PMA) plus ionomycin (IO), the expression of CD40L on CD4 lymphocytes was significantly higher in the ribavirin group compared with controls. In the ribavirin group, the increased expression of CD40L significantly correlated with reduction of HCV RNA levels with respect to pretreatment values. Finally, ribavirin treatment was not associated with modification of PMA-IO-induced cytokine production by T lymphocytes and interleukin (IL)-1beta and tumour necrosis-alpha (TNF)-alpha production by CD40L-stimulated monocytes. In conclusion, these data indicate that ribavirin -upmodulates CD40L expression on CD4 T cells, a property which may account in part for its ability to enhance the antiviral activity of interferon-alpha in the treatment of chronic HCV infection.

Adjuvants, Immunologic↗
PubMed2001

Protective role of tauroursodeoxycholate during harvesting and cold storage of human liver: a pilot study in transplant recipients.

BACKGROUND: Ischemia-reperfusion injury is a major cause of early graft dysfunction after liver transplantation. Tauroursodeoxycholic acid (TUDCA), a natural amidated hydrophilic bile salt, protects from cholestasis and hepatocellular damage in a variety of experimental models, as well as from ischemia-reperfusion injury. We investigated in the human liver transplantation setting the effect of the addition of TUDCA at time of liver harvesting and cold storage on the intra- and postoperative enzyme release and liver histopathology at the end of cold storage, at reperfusion, and 7 days after transplantation. METHODS: Eighteen patients undergoing elective liver transplantation were studied, including 6 serving as controls. In six patients, TUDCA was added to the University of Wisconsin solution used during harvesting and cold storage, to reach final concentrations of 2 mM. In three of these patients, TUDCA (3 g) was infused in the portal vein of the donor before organ explantation; in the other three cases, TUDCA was given through both routes. RESULTS: The use of TUDCA did not cause adverse events. The release of aspartate aminotransferase in the inferior vena cava blood during liver flushing was significantly lower (P=0.05) in TUDCA-treated than in control grafts, as were cytolytic enzyme levels in peripheral blood during the first postoperative week (P<0.02). At electron microscopy, an overt endothelial damage (cytoplasmic vacuolization, cell leakage, and destruction with exposure of hepatocytes to the sinusoidal lumen) was invariably found in control grafts, both at reperfusion and at day 7 after transplant. These features were significantly ameliorated by TUDCA (P<0.001). Several ultrastructural cytoplasmic abnormalities of hepatocytes were seen. Among these, damage to mitochondria matrix and crystae was significantly reduced in TUDCA-treated versus control grafts (P<0.01). Mild to severe damage of bile canaliculi was a constant feature in control biopsies, with dilatation of canalicular lumen and loss of microvilli. Both these abnormalities were markedly ameliorated (P<0.001 by TUDCA). The best preservation was observed when TUDCA was given through both routes. CONCLUSIONS: The use of TUDCA during harvesting and cold storage of human liver is associated with significant protection from ischemia-reperfusion injury. The clinical significance of this findings must be studied.

Adenosine↗
PubMed2001

Long-acting nitrates in portal hypertension: to be or not to be?

The major complication of portal hypertension is represented by gastrointestinal haemorrhage from ruptured oesophageal varices. Gold standard prophylaxis with non selective beta-blockers is able to decrease the risk of bleeding or rebleeding only in a fraction of patients, thus additional forms of treatment are under investigation. Long-acting nitrates have been considered the best candidates to improve the pharmacological response. The rationale for the use of nitrates in portal hypertension is primarily based on the fact that they lead to a decrease in the hepatic venous pressure gradient and on the knowledge that deficient intrahepatic nitric oxide release could be one of the mechanisms involved in the development of increased portal resistance in early cirrhosis. Ten randomised controlled trials have, so far, investigated the clinical usefulness of long-acting nitrates in portal hypertension. Five of them explored the field of primary prophylaxis and the others, the use of nitrates in the prevention of rebleeding. The results of these randomised controlled trials are partially contradictory as far as concerns prevention of bleeding or rebleeding, survival and treatment-related complications. A common finding emerging from most of these studies suggests that the potential for a beneficial or detrimental effect of nitrates depends on the stage of liver disease and the extension of portal collaterals. Thus, in the early stage of cirrhosis, it would be desirable to target nitrates to the liver microvasculature, while, in a later stage, nitrates could be deleterious by aggravating the hyperdynamic syndrome through the expansion of the vascular bed. Whether or not nitrates may have a role in the primary and/or secondary prophylaxis of bleeding needs to be addressed in further long-term studies.

Adrenergic beta-Antagonists↗
PubMed2001

Lack of evidence for the Th2 predominance in patients with chronic hepatitis C.

A T helper (Th)1 to Th2 shift has been proposed to be a critical pathogenic determinant in chronic hepatitis C. Here, we evaluated mitogen-induced and hepatitis C virus (HCV) core antigen-induced cytokine production in 28 patients with biopsy-proven chronic hepatitis C. Flow cytometry demonstrated that after mitogenic stimulation the percentage of Th2 cells (IL-4 + or IL-13 +) and Th0 cells (IFN-gamma/IL-4 + or IL-2/IL-13 +) did not differ between patients and controls. In contrast, the percentage of Th1 cells (IFN-gamma + or IL-2 +) was significantly increased in CD4 +, CD8 +, 'naive'-CD45RA + and 'memory'-CD45RO + T-cell subsets from patients versus controls. Similar results were obtained by ELISA testing supernatants from mitogen-stimulated, unfractionated peripheral blood mononuclear cell (PBMC) cultures. Interferon-alpha treatment was associated with a reduction in the mitogen-induced Th1 cytokine response in those patients who cleared their plasma HCV-RNA. Analysis of cytokine expression by CD4 + T cells after HCV core antigen stimulation in a subgroup of 13 chronic hepatitis C patients demonstrated no cytokine response in 74% of these patients and an IFN-gamma-restricted response in 26%. Finally, no Th2 shift was found in lipopolysaccharide-stimulated monocytes. These data indicate that a Th1 to Th2 shift does not occur in chronic hepatitis C.

Adult↗
PubMed2001

Treatment with ribavirin and interferon-alpha reduces interferon-gamma expression in patients with chronic hepatitis C.

Recent studies in vitro and in animals have suggested that ribavirin may potentiate the antihepatitis C virus (HCV) activity of interferon-alpha (IFN-alpha) by up-modulating the production of T cell-derived cytokines, such as interleukin (IL)-2 and IFN-gamma, which play a key role in the cellular immune response against HCV. To study the immune-modulatory mechanisms of ribavirin further, cytokine production by activated T cells and circulating cytokine levels were studied by FACS analysis and ELISA testing in 25 patients with chronic hepatitis C unresponsive to IFN-alpha, before and after treatment with either ribavirin plus IFN-alpha or IFN-alpha alone. After 16 weeks of treatment, both the expression of IFN-gamma by activated T cells and the blood levels of IFN-gamma, were significantly reduced with respect to pretreatment values in patients treated with ribavirin and IFN-alpha but not in those undergoing treatment with IFN-alpha alone. The expression of IFN-gamma was significantly lower in patients that gained normal ALT levels with respect to those that did not. No modification of the expression of IL-2, IL-4 and IL-10 was found before and after treatment in either group of patients. In conclusion, the results of this study do not support up-modulation of IFN-gamma and IL-2 production as the mechanism by which ribavirin potentiates IFN-alpha anti HCV activity. In addition, our findings suggest that ribavirin may exert an anti-inflammatory effect and may help reducing IFN-gamma-driven T cell activation and liver damage.

Adjuvants, Immunologic↗
PubMed2001

Prevalence, incidence and correlates of HHV-8/KSHV infection and Kaposi's sarcoma in renal and liver transplant recipients.

BACKGROUND: To determine whether the incidence of HHV-8/KSHV infection and the risk of developing KS among organ transplant recipients differ by type of organ transplanted, we calculated the rate of HHV-8/KSHV seroconversion and the risk of developing KS among renal and liver transplant recipients. METHODS: The study population consisted of renal and liver transplant recipients recruited in two transplant centres in Rome, Italy. Both pre-transplant and post-transplant serum samples were available for all participants. The prevalence of HHV-8/KSHV infection before transplantation was calculated. To determine risk factors for infection, we calculated ORs and 95% CI. Seroconversion rates (i.e. attack rates) after transplantation were also calculated. Differences in attack rates were calculated using a binomial test for proportions. RESULTS: Of the 130 participants, 21 (16.1%) were HHV-8/KSHV-positive before transplantation. Women were more likely to be infected than men, whereas no difference was observed by type of organ transplanted. Of the 109 initially negative individuals, 13 (11.9%) developed anti-HHV-8/KSHV antibodies after transplantation. The incidence of HHV-8/KSHV infection tended to be higher among liver transplant recipients. Four renal transplant recipients and none of the liver transplant recipients developed KS after transplantation. The risk of KS was higher among recipients who were already HHV-8/KSHV-positive before transplantation. CONCLUSIONS: HHV-8/KSHV seroconversion rates appear to be higher among liver transplant recipients, compared to renal transplant recipients. However, renal transplant recipients tend to have a higher risk of KS. HHV-8/KSHV reactivation appears to play a greater role on the risk of KS than incident infections.

Adolescent↗
PubMed2000

Low levels of hepatitis C virus RNA in blood of infected patients under maintenance haemodialysis with high-biocompatibility, high-permeability filters.

BACKGROUND: Patients undergoing maintenance haemodialysis are often infected with hepatitis C virus, yet the clinical course of liver disease is usually mild. We investigated whether the hepatitis C virus viral load is influenced by the haemodialytic procedure and the type of dialyser. METHODS: Hepatitis C virus-RNA levels were measured using a quantitative polymerase chain reaction assay in predialysis blood from 51 hepatitis C virus-infected patients dialysed with different membranes. Paired pre- and post-dialysis measurements were also obtained in 18 patients. RESULTS: Patients dialysed using cuprammonium-regenerated cellulose membranes with low (cuprofan) or intermediate (cellulose acetate or diacetate) biocompatibility had higher pre-dialysis hepatitis C virus-RNA levels (p<0.05] compared to those dialysed with synthetic high-biocompatibility, high-permeability polymeric membranes (polyacrylonitrile, polysulfone, polymethylmethacrylate or polycarbonate). Hepatitis C virus-RNA levels were unrelated to the duration of haemodialysis and the presence of abnormal transaminases. A significant reduction (p=0. 04) of serum hepatitis C virus-RNA levels was observed after a single haemodialysis, particularly in patients with high pre-dialysis viral load. Patients with low pre-dialysis hepatitis C virus-RNA levels (<2. 5 x 10(3) copies/ml) exhibited only minimal changes following the procedure. Four patients with medium-high basal viral load switched from a low-biocompatibility/low-permeability to a high-biocompatibility/high permeability filter had a marked reduction of viraemia after three weeks, in one case followed by a new increase after return to the original filter. CONCLUSIONS: Haemodialysis with high-biocompatibility/high-permeability filters in hepatitis C virus-infected patients is associated with low blood levels of hepatitis C virus-RNA. This finding may be of clinical relevance, especially in patients listed for kidney transplantation.

Adult↗
PubMed2000

Liver transplantation in Italy: current status. Study Group on Liver Transplantation of the Italian Association for the Study of the Liver (A.I.S.F.).

The first liver transplant in Italy was performed in 1982. With the improvement in results, the number of patients followed, in recent years, has substantially increased in all centres. In parallel, the indications for liver transplantation have expanded and have raised the need for more organized structures where patients can be referred for evaluation and transplantation. Indications and contraindications to liver transplantation in Italy, the role of retransplantation, paediatric liver transplantation, waiting list management, liver transplantation outside Italy and the new Italian laws on organ donation are discussed. The multidisciplinary Study Group on Liver Transplantation of the Italian Association for the Study of the Liver (AISF) has collected information from all the Italian centres to ascertain the degree of consistency in their methods.

Humans↗
PubMed2000

Unfavourable effects of colchicine in combination with interferon-alpha in the treatment of chronic hepatitis C.

BACKGROUND: The prognosis of chronic hepatitis depends on the progression of hepatic fibrosis. AIM: To investigate whether the antifibrotic drug colchicine, in combination with interferon-alpha has a role in the treatment of chronic hepatitis C. METHODS: Sixty-five HCV-RNA positive patients with chronic hepatitis were randomized to receive interferon-alpha, 6 MU t.i.w. for 6 months followed by 3 MU t.i.w. for further 6 months, with or without the adjunct of colchicine, 1 mg o.d., 6 days a week, for 3 years. We report an interim analysis after the first 18 months. RESULTS: Thirty-four patients received interferon-alpha and 31 received interferon-alpha and colchicine. The two groups were comparable for baseline data, including HCV-RNA levels, genotypes and histological grading/staging. Drop-outs and side-effects were similar. The proportion of patients who achieved alanine transaminase normalization or undetectable HCV-RNA at month 6 was higher in the interferon-alpha (68% and 47%, respectively) than in the interferon-alpha plus colchicine group (32% and 23%, P=0.004 and P=0. 04, respectively). End-of-treatment biochemical and virological response occurred in 41% and 29% of the interferon-alpha and 19% and 10% of the combination group, respectively (P=0.05 and P=0.05). Sustained biochemical response occurred in 26% of the interferon-alpha and 6% of the interferon-alpha plus colchicine group (P=0.03), corresponding percentages of sustained HCV-RNA loss being 21% and 3% (P=0.04). CONCLUSIONS: The combination of colchicine and interferon-alpha worsens the effectiveness of interferon-alpha alone in HCV chronic hepatitis. These alarming findings prompted us to interrupt the trial at this stage.

Adult↗