Maribel Rodríguez-Torres

Publications of Maribel Rodríguez-Torres

• Balapiravir plus peginterferon alfa-2a (40KD)/ribavirin in a randomized trial of hepatitis C genotype 1 patients.

  Authors: David R Nelson, Stefan Zeuzem, Pietro Andreone, Peter Ferenci, Robert Herring, Donald M Jensen, Patrick Marcellin, Paul J Pockros, Maribel Rodríguez-Torres, Lorenzo Rossaro, Vinod K Rustgi, Thomas Sepe, Mark Sulkowski, Isaac R Thomason, Eric M Yoshida, Anna Chan, George Hill

  Annals of hepatology : official journal of the Mexican Association of Hepatology. 01/2012; 11(1):15-31.

  Balapiravir (R1626, RG1626) is the prodrug of a nucleoside analogue inhibitor of the hepatitis C virus (HCV) RNA-dependent RNA polymerase (R1479, RG1479). This phase 2, double-blind internationalBalapiravir (R1626, RG1626) is the prodrug of a nucleoside analogue inhibitor of the hepatitis C virus (HCV) RNA-dependent RNA polymerase (R1479, RG1479). This phase 2, double-blind international trial evaluated the optimal treatment regimen of balapiravir plus peginterferon alfa-2a (40KD)/ribavirin. Treatment-naive genotype 1 patients (N = 516) were randomized to one of seven treatment groups in which they received balapiravir 500, 1,000, or 1,500 mg twice daily, peginterferon alfa-2a (40KD) 180 or 90 µg/week and ribavirin 1,000/1,200 mg/day or peginterferon alfa-2a (40KD)/ribavirin. The planned treatment duration with balapiravir was reduced from 24 to 12 weeks due to safety concerns. The percentage of patients with undetectable HCV RNA was consistently higher in all balapiravir groups from week 2 to 12. However, high rates of dose modifications and discontinuations of one/all study drugs compromised the efficacy assessment and resulted in similar sustained virological response rates in the balapiravir groups (range 32-50%) and the peginterferon alfa-2a (40KD)/ribavirin group (43%). Balapiravir was discontinued for safety reasons in 28-36% of patients (most often for lymphopenia) and the percentage of patients with serious adverse events (especially hematological, infection, ocular events) was dose related. Serious hematological adverse events (particularly neutropenia, lymphopenia) were more common in balapiravir recipients. Two deaths in the balapiravir/peginterferon alfa-2a/ribavirin combination groups were considered possibly related to study medication. Further development of balapiravir for the treatment of chronic hepatitis C has been halted because of the unacceptable benefit to risk ratio revealed in this study (www.ClinicalTrials.gov NCT 00517439).

• On the cusp of change: new therapeutic modalities for HCV.

  Authors: Maribel Rodríguez-Torres

  Annals of hepatology : official journal of the Mexican Association of Hepatology. 01/2010; 9 Suppl:123-31.

  We are at the cusp of significant new alternatives for the treatment of chronic hepatitis C. Among more than 100 drugs in development, some are ready to be approved and in the market as soon as nextWe are at the cusp of significant new alternatives for the treatment of chronic hepatitis C. Among more than 100 drugs in development, some are ready to be approved and in the market as soon as next year. The protease inhibitors telaprevir and boceprevir, will change the SOC treatment to triple therapy, (combined with peg IFN and RBV), with duration of treatment guided by rapid virological response. In this article we present the data supporting the approval of telaprevir and boceprevir, and information on polymerase inhibitors and IFN free proof of concept trials. Finally we discuss which patients should wait for DAA based therapies and which should be considered for peg IFN/RBV now. In the next 5 years our patients can expect higher response rates and truncated duration of therapy. They can expect drug cocktails or combos but for the next years these novel drugs will still require peg IFN and RBV. Also, a new era of resistance as a barrier to therapy will require sub typing and more viral monitoring. Overall, improved outcomes will come at the expense of more adverse events and increased costs of treatment.

• Weight affect relapse rates in latinos with genotype 2/3 chronic hepatitis C (CHC) treated with peg IFN alfa-2a (Pegasys) 180 mcg/week and 800 mg daily of ribavirin for 24 weeks.

  Authors: Maribel Rodríguez-Torres, Carlos F Ríos-Bedoya, Grisell Ortiz-Lasanta, Dagmary Purcell-Arevalo, Acisclo Marxuach-Cuétara, Josselyn Jiménez-Rivera

  Journal of medical virology. 09/2008; 80(9):1576-80.

  Efficacy of chronic hepatitis C (CHC) treatment with Peg-IFN and Ribavirin (RBV) is superior for genotypes 2/3 (GT-2/3) than for genotype 1 (GT-1) patients. Efficacy of treatment in Latinos infectedEfficacy of chronic hepatitis C (CHC) treatment with Peg-IFN and Ribavirin (RBV) is superior for genotypes 2/3 (GT-2/3) than for genotype 1 (GT-1) patients. Efficacy of treatment in Latinos infected with GT-2/3 is unknown. The purpose of the study was to examine efficacy of Peg-IFN/RBV in Latinos and factors that predict sustained viral response (SVR). This was a retrospective study of GT-2/3 patients treated with Peg-IFN alfa-2a and RBV for 24 weeks. Multiple baseline characteristics were evaluated. SVR and relapse rates were calculated, as well as multiple regression models performed to examine factors that predict SVR and relapse, as genotype, HVL, weight, steatosis at liver biopsy, total cholesterol triglyceride and diabetes. Thirty five consecutive patients were included in the study; [26] GT-2 and [9] GT-3. Baseline characteristics were similar between both genotypes. SVR was (18/26) or 69.2% for GT-2 and (8/9) or 88.9% for GT-3 for combined SVR of (26/35), 74.3%. Relapse rates were 28.0% for GT-2 and 11.1% for GT-3 patients for a combined relapse rate of 23.5%. Patients heavier than 75 kg had relapse rates twofold higher than leaner patients, (6/21) or 28.6% versus (2/14) or 14.3% (P = 0.088). Weight increase in kg was the only predictor for risk of relapse, P = 0.043 (SD 0.0445 95% CI 1.0026-1.1772). In conclusion, Latinos heavier than 75 kg with GT-2/3 HCV infection achieve lower SVR than those who weight less than 75 kg, because a higher relapse rate. More research in ethnic and racial minorities is needed to further establish optimal treatment in this population.

• Latinos and chronic hepatitis C: a singular population.

  Authors: Maribel Rodríguez-Torres

  Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 06/2008; 6(5):484-90.

  Latinos are the largest minority in the USA and have higher rates of HCV infection. The course of chronic hepatitis C in Latinos is more aggressive, with higher risk to develop cirrhosis than anyLatinos are the largest minority in the USA and have higher rates of HCV infection. The course of chronic hepatitis C in Latinos is more aggressive, with higher risk to develop cirrhosis than any other ethnic group or race. Available information suggests that more rapid progression of liver disease is aggravated by decreased efficacy to treatment with available therapies. The causes for more aggressive progression and decreased efficacy of treatment are complex. Factors related to metabolic syndrome, insulin resistance, and hepatic steatosis are important, as well as genetic differences, not only for metabolic syndrome but for immune responses to interferon. In addition, there are substantial barriers for Latinos to access medical care. Language, cultural differences, and socioeconomic factors, including lack of medical insurance, more frequent use of alcohol, and possible medical care provider bias, are significant obstacles to diagnosis and treatment. The severity of the liver disease and the association to metabolic syndrome medical conditions justify that Latinos be considered a special population with urgent need of intervention strategies. In this article we present all the available evidence on epidemiology, natural history of chronic hepatitis C, and efficacy of anti-HCV therapy in Latinos infected with HCV.

• Hepatic steatosis in HIV/HCV co-infected patients: correlates, efficacy and outcomes of anti-HCV therapy: a paired liver biopsy study.

  Authors: Maribel Rodríguez-Torres, Sugantha Govindarajan, Ricard Solá, Nathan Clumeck, Eduardo Lissen, Mário Pessôa, Peter Buggisch, Janice Main, Jean DePamphilis, Douglas T Dieterich

  Journal of hepatology. 06/2008; 48(5):756-64.

  BACKGROUND/AIMS: Hepatic steatosis is caused by the complex interaction of host and viral factors, such as metabolic syndrome (MS), alcoholism and HCV genotype, and in HIV-HCV co-infected patients,BACKGROUND/AIMS: Hepatic steatosis is caused by the complex interaction of host and viral factors, such as metabolic syndrome (MS), alcoholism and HCV genotype, and in HIV-HCV co-infected patients, antiretroviral therapy may also play a role. A large population of patients from the AIDS Pegasys Ribavirin International Co-infection Trial (APRICOT) had paired liver biopsies interpreted and graded for steatosis along with lipid measurements and anthropometric data. METHODS: We analyzed these patients to determine the prevalence of steatosis, baseline factors associated with steatosis, effect of steatosis in HCV therapy efficacy and the impact of anti-HCV treatment on steatosis. RESULTS: A total of 65/283 (23%) patients with paired biopsies were positive for steatosis. Patients with steatosis were significantly more likely to have HCV genotype 3, bridging fibrosis/cirrhosis, higher HCV RNA levels, increased triglycerides and lower cholesterol levels. The only different body measurement was neck circumference which was greater in patients with steatosis and significantly decreased from baseline during the study. Hip circumference was predictive of steatosis at baseline. CONCLUSIONS: Factors associated to the metabolic syndrome are important in co-infected patients. Treatment outcome affected steatosis in that viral eradication reduced steatosis in genotype 3 patients, but altogether steatosis did not affect efficacy of treatment in any genotype.

• Effect of hepatitis C virus treatment in fibrosis progression rate (FPR) and time to cirrhosis (TTC) in patients co-infected with human immunodeficiency virus: a paired liver biopsy study.

  Authors: Maribel Rodríguez-Torres, José F Rodríguez-Orengo, Carlos F Ríos-Bedoya, Alberto Fernández-Carbia, Acisclo M Marxuach-Cuétara, Abimael López-Torres, Josselyn Jiménez-Rivera

  Journal of hepatology. 05/2007; 46(4):613-9.

  BACKGROUND/AIMS: Patients with hepatitis C and human immunodeficiency virus coinfection have rapid fibrosis progression. The effect on fibrosis progression rate and time to cirrhosis of HCV treatmentBACKGROUND/AIMS: Patients with hepatitis C and human immunodeficiency virus coinfection have rapid fibrosis progression. The effect on fibrosis progression rate and time to cirrhosis of HCV treatment has not been extensively studied. First aim of the study was to assess changes in FPR and TTC and staging after HCV therapy vs. no treatment. Secondary aim was to study changes in FPR/staging of sustained viral responders and non-responders to Peg-IFN alfa-2a and RBV. METHODS: Seventy-four (74) co-infected patients were grouped in three according to HCV treatment, Group 1 - None (n=9), Group 2 - IFN (n=30), Group 3-Peg-IFN alfa-2a (n=35). Paired liver biopsies were analyzed and FPR/TTC calculated for each biopsy. RESULTS: Baseline characteristics, duration of treatment and time between biopsies were similar among groups. HCV therapy, improved grading, but only Peg-IFN alfa-2a therapy resulted in staging decrease. Group 2 had significant staging increase and Group 1 had doubling of FPR and (TTC) reduction from 22.7 to 9.09 years. Peg-IFN alfa-2a treated patients had negative change in FPR and stabilization in TTC. SVR and NR with Peg-IFN alfa-2a/RBV had same FPR and staging. CONCLUSIONS: In patients with HIV/HCV co-infection Peg-IFN alfa 2a based treatment produced regression or stable fibrosis in contrast to accelerated progression in those without treatment.

• Efficacy and safety of peg-IFN alfa-2a with ribavirin for the treatment of HCV/HIV coinfected patients who failed previous IFN based therapy.

  Authors: Maribel Rodríguez-Torres, José F Rodríguez-Orengo, Carlos F Ríos-Bedoya, Alberto Fernández-Carbia, Elsa González-Lassalle, Rosa Salgado-Mercado, Acisclo M Marxuach-Cuétara

  Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology. 01/2007; 38(1):32-8.

  BACKGROUND: Interferon (IFN) regimens for HCV treatment are less effective in HCV/HIV-coinfected patients. There are no effective treatments for patients who fail IFN therapies. We examined theBACKGROUND: Interferon (IFN) regimens for HCV treatment are less effective in HCV/HIV-coinfected patients. There are no effective treatments for patients who fail IFN therapies. We examined the safety and efficacy of peginterferon alfa-2a (peg-IFNalpha-2a) plus ribavirin (RBV) in 41HCV/HIV-coinfected patients non-responsive to prior IFN treatment. METHODS: Patients received peg-IFNalpha-2a (180mg/week) plus RBV (800mg/day) for 24 weeks (n=41). At week 24, patients with non-detectable HCV RNA or > or =2-log decrease from baseline, received peg-IFNalpha-2a (180mg/week) plus RBV (800mg/day) for 24 weeks further. Patients not responding to treatment at week 24 were discontinued. RESULTS: Intent to treat (ITT) sustained viral response (SVR) was 21.9%. Patients who received at least 24 weeks of peg-IFNalpha-2a plus RBV treatment (n=35), SVR rates were 25.7%. SVR was associated with significant improvements in liver histology grade (p=0.02), stage (p=0.02), and fibrosis progression rate (FPR) (p=0.03). Patients that failed to achieve SVR had statistically significant decreases in grade (p=0.09) and FPR (p=0.01). CONCLUSION: peg-IFNalpha-2a plus RBV is effective and safe to achieve SVR in HCV/HIV coinfected patients non-responsive to prior IFN treatment. Patients that achieve SVR have significant improvements in liver histology parameters. In patients that do not achieve SVR there are histological benefits beyond virological response that suggest that peg-IFNalpha-2a+RBV therapy may decrease risk of progression to end stage liver disease.

• Chronic hepatitis C in patients with persistently normal alanine transaminase levels.

  Authors: Mitchell L Shiffman, Moisés Diago, Albert Tran, Paul Pockros, Robert Reindollar, Daniele Prati, Maribel Rodríguez-Torres, Pilar Lardelli, Steven Blotner, Stefan Zeuzem

  Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 05/2006; 4(5):645-52.

  BACKGROUND & AIMS: Many patients with chronic hepatitis C virus (HCV) have persistently normal serum alanine transaminase (ALT) levels. We compared characteristics of chronic hepatitis C patientsBACKGROUND & AIMS: Many patients with chronic hepatitis C virus (HCV) have persistently normal serum alanine transaminase (ALT) levels. We compared characteristics of chronic hepatitis C patients with patients with normal and elevated ALT levels using data from 3 randomized phase III trials of peginterferon alfa-2a (40 kDa). METHODS: The characteristics of 480 patients with normal ALT values (on >or=3 occasions without any increases in ALT level over a 6- to 18-month period) and 1993 patients with elevated ALT levels were compared. Sixty-eight of the 480 patients with normal ALT levels were randomized to no treatment and monitored for 72 weeks. RESULTS: More patients with normal ALT levels than patients with elevated ALT levels were women (59% vs 32%; P<.01). The serum HCV RNA titer was significantly lower in patients with normal ALT levels (P<.01 vs in patients with elevated ALT levels). Patients with normal ALT levels had significantly lower inflammation and fibrosis scores on liver biopsy examination than patients with elevated ALT levels, but almost two-thirds had portal fibrosis and 10% had bridging fibrosis. No correlation between baseline ALT activity, HCV RNA level, and liver histology was observed in patients with normal ALT levels. During the 72-week follow-up period, ALT activity elevated above the upper limit of normal in 53% of the untreated patients with normal levels of ALT. None became HCV RNA undetectable. CONCLUSIONS: Chronic hepatitis C patients with normal ALT levels should be evaluated in a similar manner as patients with elevated ALT levels because they are at risk for developing significant liver disease. The decision to treat with peginterferon alfa and ribavirin should be based on multiple factors, rather than on ALT levels alone.

• Progression to cirrhosis in Latinos with chronic hepatitis C: differences in Puerto Ricans with and without human immunodeficiency virus coinfection and along gender.

  Authors: Maribel Rodríguez-Torres, Carlos F Ríos-Bedoya, José Rodríguez-Orengo, Alberto Fernández-Carbia, Acisclo M Marxuach-Cuétara, Abimael López-Torres, Rosa Salgado-Mercado, Norbert Bräu

  Journal of clinical gastroenterology. 05/2006; 40(4):358-66.

  BACKGROUND: Hepatitis C virus (HCV) infection is prevalent in Latinos. There is some evidence that progression to cirrhosis is more rapid. END POINTS: To calculate time of cirrhosis from time of HCVBACKGROUND: Hepatitis C virus (HCV) infection is prevalent in Latinos. There is some evidence that progression to cirrhosis is more rapid. END POINTS: To calculate time of cirrhosis from time of HCV infection in a large Latino population. Other end points were to assess variables that predict cirrhosis and the effect of gender, alcohol, and human immunodeficiency virus (HIV) infection status on time to cirrhosis. METHODS: Four hundred sixty-nine Latino patients evaluated at a referral center in Puerto Rico were included. Several demographic parameters, such as risk factors, estimated duration of HCV infection, alcohol use, HIV status, and findings from the usual HCV and HIV laboratory tests were noted. All patients had liver biopsy specimens assessed by Ishak score. RESULTS: Monoinfected and coinfected latinos have a median cumulative risk/hazard for cirrhosis of 42.0 vs. 32.0 years after infection (P = 0.0016). The median age of cirrhotic patients is 53.0 years in monoinfections and 42.0 years in coinfection. Among coinfected patients there is no gender-associated difference in time to onset of cirrhosis (P = 0.785). Among monoinfected patients, males have a shorter median risk/hazard to cirrhosis than females (11.0-year difference; P = 0.05) and have a shorter time until onset of cirrhosis by fibrosis progression rate (FPR) (33.33 vs. 41.66 years; P = 0.021). There is no difference between male patients with regard to HIV status (P = 0.199). Alcohol use is significant in monoinfected males (59.2 g/day) vs. females (11.4 g/day; P = 0.001). Variables that predict cirrhosis are male sex, age, and Ishak grade in monoinfected patients and alanine aminotransferase value in coinfected patients. CONCLUSIONS: Puerto Ricans with HCV have a median risk/hazard time to cirrhosis at younger age than other populations. Males who are HIV/HCV-coinfected have the same median risk/hazard and time to cirrhosis than those monoinfected with HCV. Special attention for early diagnosis and treatment is mandatory.

• Double-blind pilot study of mesalamine vs. placebo for treatment of chronic diarrhea and nonspecific colitis in immunocompetent HIV patients.

  Authors: Maribel Rodríguez-Torres, Jose F Rodríguez-Orengo, Carlos F Ríos-Bedoya, Alberto Fernández-Carbia, Rosa Salgado-Mercado, Acisclo M Marxuach-Cuétara

  Digestive diseases and sciences. 02/2006; 51(1):161-7.

  Chronic diarrhea and colitis are common in patients positive for human immunodeficiency virus (HIV) under highly active antiretroviral treatment (HAART). This prospective double-blind study exploresChronic diarrhea and colitis are common in patients positive for human immunodeficiency virus (HIV) under highly active antiretroviral treatment (HAART). This prospective double-blind study explores the effect of mesalamine vs. placebo in HIV-positive patients. Thirteen HIV-infected patients with noninfectious chronic diarrhea and > 250 CD4+ cells/mm(3) were randomized to mesalamine (2.4 g/day; n = 9) or placebo (n = 4) for 6 weeks. Colonoscopy was performed at baseline and week 6, and biopsies were obtained to calculate the Biopsy Activity Index (BAI). Diarrhea was assessed at baseline and end of treatment using the Disease Activity Index (DAI). Patients and clinicians completed Patient Global Improvement index (PGI) and Clinical Global Improvement index (CGI) at weeks 2 and 6. Comparisons at week 6 were statistically significant between mesalamine and placebo groups for BAI (P = 0.03), DAI (P = 0.007), PGI (P = 0.008), and CGI (P = 0.008). Furthermore, major improvements were documented in the mesalamine group at week 6 compared to baseline for all variables, whereas the placebo group did not have any. Mesalamine was effective for treatment of chronic diarrhea and moderate nonspecific colitis in HIV patients.

• Slower fibrosis progression in HIV/HCV-coinfected patients with successful HIV suppression using antiretroviral therapy.

  Authors: Norbert Bräu, Mirella Salvatore, Carlos F Ríos-Bedoya, Alberto Fernández-Carbia, Fiorenzo Paronetto, José F Rodríguez-Orengo, Maribel Rodríguez-Torres

  Journal of hepatology. 02/2006; 44(1):47-55.

  BACKGROUND/AIMS: HIV/HCV-coinfected patients reportedly have a faster fibrosis progression rate (FPR) than HCV-monoinfected patients. This study examined whether HIV suppression through highly activeBACKGROUND/AIMS: HIV/HCV-coinfected patients reportedly have a faster fibrosis progression rate (FPR) than HCV-monoinfected patients. This study examined whether HIV suppression through highly active antiretroviral therapy (HAART) attenuates this accelerated fibrosis progression. METHODS: In two hepatitis C centers, a retrospective analysis identified 656 consecutive treatment-naïve HCV-infected patients who had undergone a liver biopsy, had a presumed date of HCV infection, and had been tested for HIV, 274 of them HIV-positive (95.2% on HAART) and 382 HIV-negative. The primary outcome measure was the FPR, defined as Ishak fibrosis score [0-6] over estimated duration of HCV infection. RESULTS: Among HIV/HCV-coinfected patients, 51.2% had undetectable HIV RNA (< 400 copies/mL). There was no difference in FPR between HIV/HCV-coinfected and HCV-monoinfected patients (0.136 vs. 0.128 Ishak fibrosis units/year, P=0.29). However, HIV/HCV-coinfected patients with any detectable HIV viral load >400 copies/mL had a faster FPR (0.151) than HCV-monoinfected patients (0.128, P=0.015) and than HIV/HCV-coinfected patients with undetectable plasma HIV RNA (0.122, P=0.013) who in turn had the same FPR as HCV-monoinfected subjects (0.128, P=0.52). An accelerated FPR in HIV viremic patients was seen with CD4+ cells <500/mm(3) (0.162 vs. 0.123, undetectable HIV RNA, P=0.005) but not with CD4+ cells >500/mm(3) (0.118 vs. 0.121, P=0.89). In multivariable linear regression analysis of HIV/HCV-coinfected patients, log(10) HIV RNA level, necroinflammation, and age at HCV infection were independently correlated to FPR, but not alcohol use or CD4+ cell count (r(2)=0.45 for model). CONCLUSIONS: HIV/HCV-coinfected patients with undetectable HIV RNA through HAART have a slower FPR than those with any HIV RNA level and an FPR similar to HCV-monoinfected individuals.

• High eradication rates of Helicobacter pylori infection with first- and second-line combination of esomeprazole, tetracycline, and metronidazole in patients allergic to penicillin.

  Authors: Maribel Rodríguez-Torres, Rosa Salgado-Mercado, Carlos F Ríos-Bedoya, Edgardo Aponte-Rivera, Acisclo M Marxuach-Cuétara, José F Rodríguez-Orengo, Alberto Fernández-Carbia

  Digestive diseases and sciences. 04/2005; 50(4):634-9.

  H. pylori eradication is a challenge in patients allergic to penicillin, both first-line and failures of prior therapy. We aimed to assess the eradication rate of H. pylori in patients allergic toH. pylori eradication is a challenge in patients allergic to penicillin, both first-line and failures of prior therapy. We aimed to assess the eradication rate of H. pylori in patients allergic to penicillin, first-line and failures of prior therapy, the efficacy of healing of active duodenal ulcer disease (DUD) and erosive gastritis, and the safety and tolerability of the combination. Twenty patients with documented allergy to penicillin, DUD, and H. pylori infection, 17 (85%) for first-line treatment and 3 (15%) prior therapy failures, were given a 10-day regimen of esomeprazole, 40 mg qid, tetracycline, 500 mg qid, and metronidazole, 500 mg qid. Baseline and follow-up panendoscopy > or =30 days after end of treatment was performed for rapid urease test (Clotest), and four site biopsies for H. pylori, and to document endoscopic peptic ulcer disease. All adverse events during treatment were documented. Eradication rates by intention to treat (ITT) were 85% for first-line treatment and 100% for failures. Seventy percent of all cases had a normal endoscopy at follow-up, and 85 and 100% of patients had healed erosive gastritis and DUD, respectively, from baseline. There were histological improvements in most patients. A high eradication rate was obtained even in patients who had a shorter duration of treatment. The combination was well tolerated. A combination of esomeprazole, tetracycline, and metronidazole is effective for eradication of H. pylori in patients allergic to penicillin, for both first-line treatment and failures of prior treatment.

• Thyroid dysfunction (TD) among chronic hepatitis C patients with mild and severe hepatic fibrosis.

  Authors: Maribel Rodríguez-Torres, Carlos F Ríos-Bedoya, Grisell Ortiz-Lasanta, Acisclo M Marxuach-Cuétara, Josselyn Jiménez-Rivera

  Annals of hepatology : official journal of the Mexican Association of Hepatology. 7(1):72-7.

  BACKGROUND: Thyroid dysfunction (TD) is associated to chronic hepatitis C (HCV) and interferon (IFN) therapy. The prevalence of TD at baseline and during IFN therapy among stages of hepatic fibrosisBACKGROUND: Thyroid dysfunction (TD) is associated to chronic hepatitis C (HCV) and interferon (IFN) therapy. The prevalence of TD at baseline and during IFN therapy among stages of hepatic fibrosis is unknown. GOALS: To examine the frequency of TD at baseline and during Peg-IFN therapy among patients with severe and mild fibrosis. STUDY: 100 patients were treated with Peg-IFN and divided in 2 groups (50 each), according to liver histology; Metavir 0-2 (mild fibrosis) and Metavir 3-4 (severe fibrosis). Baseline TD was defined as history of TD, or abnormal thyroid stimulating hormone (TSH) or antiperoxidase thyroid auto-antibodies (TPO -Ab). Frequency of TD during therapy was defined as TD that required treatment. RESULTS: 20% in the severe fibrosis group and 10% in the mild fibrosis group, had TD at baseline. Most of the cases, 31.4% were female as compared to 6.25% males. During therapy, 24% of patients in the severe fibrosis group, compared to 12% in the mild fibrosis, had TD. Most patients had biochemical hypothyroidism, and 66% were female, compared to 33.33 % male. TPO-Ab predicted TD during therapy in 50% of cases while those negative only had 16.6% TD during IFN therapy. CONCLUSIONS: Patients with severe fibrosis have more TD events at baseline and during treatment with Peg IFN alfa-2a. Patients with more hepatic fibrosis require careful attention to diagnose and manage TD. More research in the immune mechanisms of hepatic fibrosis progression and autoimmune complications is needed.