<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03296930</url>
  </required_header>
  <id_info>
    <org_study_id>DAAs on Normal Kidney</org_study_id>
    <nct_id>NCT03296930</nct_id>
  </id_info>
  <brief_title>Effect Of DAAs For Treatment Of HCV On Normal Kidney</brief_title>
  <official_title>Effect Of Interferon-Free Direct Acting Antiviral Agents For Treatment Of Hepatitis C Virus Patients On The Normal Kidney</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to determine the effect of different direct acting antiviral drugs&#xD;
      used for treatment of chronic HCV infected patients on normal kidney.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatitis C virus (HCV) infection is a major health problem. The World Health Organization&#xD;
      (WHO) estimated that at least 150-170 million people, approximately 3% of the world's&#xD;
      population, are chronically infected. These patients are known to be at risk of developing&#xD;
      liver complications, i.e., cirrhosis and liver cancer, with an estimated liver-related&#xD;
      mortality of 350,000 people/year. However, the risks of morbidity and mortality are&#xD;
      underestimated because they do not take into account the extra-hepatic consequences of HCV&#xD;
      infection. Numerous extra-hepatic manifestations (HCV-EHMs) have been reported. In some large&#xD;
      cohort studies, up to 74% of patients experienced HCV-EHMs of different severity, from&#xD;
      perceived to disabling conditions.&#xD;
&#xD;
      Treatment of HCV infection has a long history. It began with interferon (IFN) mono-therapy,&#xD;
      with less than 20% sustained virological response (SVR). Milestones include the addition of&#xD;
      ribavirin (RBV) to the treatment protocol and providing pegylated-IFN (PegIFN) as an&#xD;
      alternative treatment.&#xD;
&#xD;
      Treatment with PegIFN/RBV was the standard of care for about 10 years. The success rate of&#xD;
      treatment with this regimen is very dependent on patient characteristics, including age, body&#xD;
      mass index, ethnicity, and genetic factors.&#xD;
&#xD;
      Viral factors, especially HCV genotype, also affect the response to HCV treatment, and there&#xD;
      are always additional factors that should be taken into account in each treatment approach,&#xD;
      including treatment success rate, duration, cost, and side effects.&#xD;
&#xD;
      In light of these concerns, attempts have continued to introduce better therapeutic regimens.&#xD;
&#xD;
      Treatment of chronic HCV infection has been revolutionized in recent years. The FDA has&#xD;
      approved different IFN-free direct acting antiviral regimens (DAAs) including: Sofosbuvir&#xD;
      (SOF) in combination with Ledipasvir (LDV), combination of Ombitasvir/Paritaprevir/ Dasabuvir&#xD;
      (a three direct acting antiviral, or 3D), combination therapy with Grazoprevir/Elbasvir&#xD;
      (GZR/EBR), Simeprevir (SMV) and Daclatasvir (DCV) also in combination with SOF.&#xD;
&#xD;
      More than 95% of patients have a sustained viral response (SVR) using DAA. The recent Cohort&#xD;
      studies have demonstrated that the new regimens of DAAs may be associated with renal side&#xD;
      effects, especially when using SOF combinations. So, to aid in the correct use of DAAs in&#xD;
      treatment of HCV patients, their potential renal toxicity must be known.&#xD;
&#xD;
      The close monitoring of renal function is required. Although, new DAAs were well tolerated,&#xD;
      recent real-life studies have demonstrated some nephrotoxic effect in Frail populations&#xD;
      treated with SOF based regimens.&#xD;
&#xD;
      The use of direct acting antiviral agents (DAAs) in HCV patients might be expected to result&#xD;
      in improved outcomes in hepatic functions even in end stage liver disease. But, the effect of&#xD;
      DAAs on the kidney still needing a specific study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">October 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of the direct acting antiviral agents used for HCV treatment on the function of the normal kidney by measurement of serum creatinine.</measure>
    <time_frame>one year</time_frame>
    <description>assessment of the renal toxicity of direct acting antivirals used for HCV treatment by measurement of the serum creatinine to detect any deviation beyond the normal values.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Antiviral Drug Adverse Reaction</condition>
  <arm_group>
    <arm_group_label>first drug group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sofosbuvir 400 MG Oral Tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>second drug group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ombitasvir/paritaprevir/ritonavir</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sofosbuvir 400 MG Oral Tablet,</intervention_name>
    <description>Interferon free direct acting antiviral drugs used for treatment of HCV.</description>
    <arm_group_label>first drug group</arm_group_label>
    <other_name>daclatasvir</other_name>
    <other_name>ribavirin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ombitasvir/paritaprevir/ritonavir</intervention_name>
    <description>Interferon free direct acting antiviral drugs used for treatment of HCV.</description>
    <arm_group_label>second drug group</arm_group_label>
    <other_name>ribavirin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both male and female patients with age above 18 years presented with chronic HCV&#xD;
             infection (diagnosed by HCV RNA positive) with normal kidney functions, i.e.:&#xD;
&#xD;
               -  Normal S.creatinine&#xD;
&#xD;
               -  Normal urine analysis (without proteinuria, haematuria or abnormal casts).&#xD;
&#xD;
               -  Normal renal sonography.&#xD;
&#xD;
          -  and candidate for direct acting antiviral drugs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any chronic HCV patient with known renal disease.&#xD;
&#xD;
          -  Patients with abnormal kidney functions, i.e.:&#xD;
&#xD;
               -  Abnormal S.creatinine.&#xD;
&#xD;
               -  Abnormal urine analysis (with proteinuria, haematuria or abnormal casts).&#xD;
&#xD;
               -  Abnormal renal US&#xD;
&#xD;
          -  Any other known renal disease (lupus nephritis, diabetic nephropathy).&#xD;
&#xD;
          -  Severe co-morbidity as severe heart failure or malignancy.&#xD;
&#xD;
          -  Other liver disease (autoimmune hepatitis, HBV, Wilson, ……).&#xD;
&#xD;
          -  Decompansated liver disease (ascites, hepatic encephalopathy, …).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zainelabdeen A Sayed, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Assistant Professor of Internal Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohammed M Abdallah, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor of Internal Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hazem Y Shouman, M.B.B.Ch</last_name>
    <phone>+201111114746</phone>
    <email>dr.hazem.shoman1@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Behnava B, Sharafi H, Keshvari M, Pouryasin A, Mehrnoush L, Salimi S, Karimi Elizee P, Ghazimoghaddam M, Alavian SM. The Role of Polymorphisms Near the IL28B Gene on Response to Peg-Interferon and Ribavirin in Thalassemic Patients With Hepatitis C. Hepat Mon. 2016 Jan 23;16(1):e32703. doi: 10.5812/hepatmon.32703. eCollection 2016 Jan.</citation>
    <PMID>27110259</PMID>
  </reference>
  <reference>
    <citation>Cacoub P, Gragnani L, Comarmond C, Zignego AL. Extrahepatic manifestations of chronic hepatitis C virus infection. Dig Liver Dis. 2014 Dec 15;46 Suppl 5:S165-73. doi: 10.1016/j.dld.2014.10.005. Epub 2014 Nov 8.</citation>
    <PMID>25458776</PMID>
  </reference>
  <reference>
    <citation>Carrier P, Essig M, Debette-Gratien M, Sautereau D, Rousseau A, Marquet P, Jacques J, Loustaud-Ratti V. Anti-hepatitis C virus drugs and kidney. World J Hepatol. 2016 Nov 18;8(32):1343-1353. doi: 10.4254/wjh.v8.i32.1343.</citation>
    <PMID>27917261</PMID>
  </reference>
  <reference>
    <citation>European Association for Study of Liver. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21. No abstract available.</citation>
    <PMID>25911336</PMID>
  </reference>
  <reference>
    <citation>Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, Tam E, Marinho RT, Tsai N, Nyberg A, Box TD, Younes Z, Enayati P, Green S, Baruch Y, Bhandari BR, Caruntu FA, Sepe T, Chulanov V, Janczewska E, Rizzardini G, Gervain J, Planas R, Moreno C, Hassanein T, Xie W, King M, Podsadecki T, Reddy KR; PEARL-III Study; PEARL-IV Study. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med. 2014 May 22;370(21):1983-92. doi: 10.1056/NEJMoa1402338. Epub 2014 May 4.</citation>
    <PMID>24795200</PMID>
  </reference>
  <reference>
    <citation>Haj-Sheykholeslami A, Keshvari M, Sharafi H, Pouryasin A, Hemmati K, Mohammadzadehparjikolaei F. Interferon-lambda polymorphisms and response to pegylated interferon in Iranian hepatitis C patients. World J Gastroenterol. 2015 Aug 7;21(29):8935-42. doi: 10.3748/wjg.v21.i29.8935.</citation>
    <PMID>26269684</PMID>
  </reference>
  <reference>
    <citation>Kwo P, Gitlin N, Nahass R, Bernstein D, Etzkorn K, Rojter S, Schiff E, Davis M, Ruane P, Younes Z, Kalmeijer R, Sinha R, Peeters M, Lenz O, Fevery B, De La Rosa G, Scott J, Witek J. Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study. Hepatology. 2016 Aug;64(2):370-80. doi: 10.1002/hep.28467. Epub 2016 Mar 22.</citation>
    <PMID>26799692</PMID>
  </reference>
  <reference>
    <citation>Lee SS, Bain VG, Peltekian K, Krajden M, Yoshida EM, Deschenes M, Heathcote J, Bailey RJ, Simonyi S, Sherman M; CANADIAN PEGASYS STUDY GROUP. Treating chronic hepatitis C with pegylated interferon alfa-2a (40 KD) and ribavirin in clinical practice. Aliment Pharmacol Ther. 2006 Feb 1;23(3):397-408. doi: 10.1111/j.1365-2036.2006.02748.x. Erratum In: Aliment Pharmacol Ther. 2006 Apr 1;23(7):1029.</citation>
    <PMID>16422999</PMID>
  </reference>
  <reference>
    <citation>Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001 Sep 22;358(9286):958-65. doi: 10.1016/s0140-6736(01)06102-5.</citation>
    <PMID>11583749</PMID>
  </reference>
  <reference>
    <citation>Pawlotsky JM. New hepatitis C therapies: the toolbox, strategies, and challenges. Gastroenterology. 2014 May;146(5):1176-92. doi: 10.1053/j.gastro.2014.03.003. Epub 2014 Mar 12.</citation>
    <PMID>24631495</PMID>
  </reference>
  <reference>
    <citation>Sharafi H, Alavian SM. IL28B polymorphism, Explanation for Different Responses to Therapy in Hepatitis C Patients. Hepat Mon. 2011 Dec;11(12):958-9. doi: 10.5812/kowsar.1735143X.794. Epub 2011 Dec 20. No abstract available.</citation>
    <PMID>22368678</PMID>
  </reference>
  <reference>
    <citation>Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, Lawitz E, Lok AS, Hinestrosa F, Thuluvath PJ, Schwartz H, Nelson DR, Everson GT, Eley T, Wind-Rotolo M, Huang SP, Gao M, Hernandez D, McPhee F, Sherman D, Hindes R, Symonds W, Pasquinelli C, Grasela DM; AI444040 Study Group. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014 Jan 16;370(3):211-21. doi: 10.1056/NEJMoa1306218. Erratum In: N Engl J Med. 2014 Apr 10;370(15):1469.</citation>
    <PMID>24428467</PMID>
  </reference>
  <reference>
    <citation>Tong MJ, Reddy KR, Lee WM, Pockros PJ, Hoefs JC, Keeffe EB, Hollinger FB, Hathcote EJ, White H, Foust RT, Jensen DM, Krawitt EL, Fromm H, Black M, Blatt LM, Klein M, Lubina J. Treatment of chronic hepatitis C with consensus interferon: a multicenter, randomized, controlled trial. Consensus Interferon Study Group. Hepatology. 1997 Sep;26(3):747-54. doi: 10.1002/hep.510260330.</citation>
    <PMID>9303508</PMID>
  </reference>
  <reference>
    <citation>Zeuzem S, Ghalib R, Reddy KR, Pockros PJ, Ben Ari Z, Zhao Y, Brown DD, Wan S, DiNubile MJ, Nguyen BY, Robertson MN, Wahl J, Barr E, Butterton JR. Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial. Ann Intern Med. 2015 Jul 7;163(1):1-13. doi: 10.7326/M15-0785.</citation>
    <PMID>25909356</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 16, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Hazem shoman</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <keyword>Direct Acting Antiviral Agents (DAAs)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
    <mesh_term>Ribavirin</mesh_term>
    <mesh_term>Sofosbuvir</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03296930
org study id: DAAs on Normal Kidney
nct id: NCT03296930
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to determine the effect of different direct acting antiviral drugs
      used for treatment of chronic HCV infected patients on normal kidney.
Hepatitis C virus (HCV) infection is a major health problem. The World Health Organization
      (WHO) estimated that at least 150-170 million people, approximately 3% of the world's
      population, are chronically infected. These patients are known to be at risk of developing
      liver complications, i.e., cirrhosis and liver cancer, with an estimated liver-related
      mortality of 350,000 people/year. However, the risks of morbidity and mortality are
      underestimated because they do not take into account the extra-hepatic consequences of HCV
      infection. Numerous extra-hepatic manifestations (HCV-EHMs) have been reported. In some large
      cohort studies, up to 74% of patients experienced HCV-EHMs of different severity, from
      perceived to disabling conditions.

      Treatment of HCV infection has a long history. It began with interferon (IFN) mono-therapy,
      with less than 20% sustained virological response (SVR). Milestones include the addition of
      ribavirin (RBV) to the treatment protocol and providing pegylated-IFN (PegIFN) as an
      alternative treatment.

      Treatment with PegIFN/RBV was the standard of care for about 10 years. The success rate of
      treatment with this regimen is very dependent on patient characteristics, including age, body
      mass index, ethnicity, and genetic factors.

      Viral factors, especially HCV genotype, also affect the response to HCV treatment, and there
      are always additional factors that should be taken into account in each treatment approach,
      including treatment success rate, duration, cost, and side effects.

      In light of these concerns, attempts have continued to introduce better therapeutic regimens.

      Treatment of chronic HCV infection has been revolutionized in recent years. The FDA has
      approved different IFN-free direct acting antiviral regimens (DAAs) including: Sofosbuvir
      (SOF) in combination with Ledipasvir (LDV), combination of Ombitasvir/Paritaprevir/ Dasabuvir
      (a three direct acting antiviral, or 3D), combination therapy with Grazoprevir/Elbasvir
      (GZR/EBR), Simeprevir (SMV) and Daclatasvir (DCV) also in combination with SOF.

      More than 95% of patients have a sustained viral response (SVR) using DAA. The recent Cohort
      studies have demonstrated that the new regimens of DAAs may be associated with renal side
      effects, especially when using SOF combinations. So, to aid in the correct use of DAAs in
      treatment of HCV patients, their potential renal toxicity must be known.

      The close monitoring of renal function is required. Although, new DAAs were well tolerated,
      recent real-life studies have demonstrated some nephrotoxic effect in Frail populations
      treated with SOF based regimens.

      The use of direct acting antiviral agents (DAAs) in HCV patients might be expected to result
      in improved outcomes in hepatic functions even in end stage liver disease. But, the effect of
      DAAs on the kidney still needing a specific study.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Effect of the direct acting antiviral agents used for HCV treatment on the function of the normal kidney by measurement of serum creatinine.
time frame: one year
description: assessment of the renal toxicity of direct acting antivirals used for HCV treatment by measurement of the serum creatinine to detect any deviation beyond the normal values.
arm group label: first drug group
arm group type: Active Comparator
description: Sofosbuvir 400 MG Oral Tablet
arm group label: second drug group
arm group type: Active Comparator
description: Ombitasvir/paritaprevir/ritonavir
intervention type: Drug
intervention name: Sofosbuvir 400 MG Oral Tablet,
description: Interferon free direct acting antiviral drugs used for treatment of HCV.
arm group label: first drug group
other name: daclatasvir
other name: ribavirin
intervention type: Drug
intervention name: Ombitasvir/paritaprevir/ritonavir
description: Interferon free direct acting antiviral drugs used for treatment of HCV.
arm group label: second drug group
other name: ribavirin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Zainelabdeen A Sayed, MD
role: Study Chair
affiliation: Assistant Professor of Internal Medicine
last name: Mohammed M Abdallah, MD
role: Study Chair
affiliation: Professor of Internal Medicine
last name: Hazem Y Shouman, M.B.B.Ch
phone: +201111114746
email: dr.hazem.shoman1@gmail.com
citation: Behnava B, Sharafi H, Keshvari M, Pouryasin A, Mehrnoush L, Salimi S, Karimi Elizee P, Ghazimoghaddam M, Alavian SM. The Role of Polymorphisms Near the IL28B Gene on Response to Peg-Interferon and Ribavirin in Thalassemic Patients With Hepatitis C. Hepat Mon. 2016 Jan 23;16(1):e32703. doi: 10.5812/hepatmon.32703. eCollection 2016 Jan.
PMID: 27110259
citation: Cacoub P, Gragnani L, Comarmond C, Zignego AL. Extrahepatic manifestations of chronic hepatitis C virus infection. Dig Liver Dis. 2014 Dec 15;46 Suppl 5:S165-73. doi: 10.1016/j.dld.2014.10.005. Epub 2014 Nov 8.
PMID: 25458776
citation: Carrier P, Essig M, Debette-Gratien M, Sautereau D, Rousseau A, Marquet P, Jacques J, Loustaud-Ratti V. Anti-hepatitis C virus drugs and kidney. World J Hepatol. 2016 Nov 18;8(32):1343-1353. doi: 10.4254/wjh.v8.i32.1343.
PMID: 27917261
citation: European Association for Study of Liver. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21. No abstract available.
PMID: 25911336
citation: Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, Tam E, Marinho RT, Tsai N, Nyberg A, Box TD, Younes Z, Enayati P, Green S, Baruch Y, Bhandari BR, Caruntu FA, Sepe T, Chulanov V, Janczewska E, Rizzardini G, Gervain J, Planas R, Moreno C, Hassanein T, Xie W, King M, Podsadecki T, Reddy KR; PEARL-III Study; PEARL-IV Study. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med. 2014 May 22;370(21):1983-92. doi: 10.1056/NEJMoa1402338. Epub 2014 May 4.
PMID: 24795200
citation: Haj-Sheykholeslami A, Keshvari M, Sharafi H, Pouryasin A, Hemmati K, Mohammadzadehparjikolaei F. Interferon-lambda polymorphisms and response to pegylated interferon in Iranian hepatitis C patients. World J Gastroenterol. 2015 Aug 7;21(29):8935-42. doi: 10.3748/wjg.v21.i29.8935.
PMID: 26269684
citation: Kwo P, Gitlin N, Nahass R, Bernstein D, Etzkorn K, Rojter S, Schiff E, Davis M, Ruane P, Younes Z, Kalmeijer R, Sinha R, Peeters M, Lenz O, Fevery B, De La Rosa G, Scott J, Witek J. Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study. Hepatology. 2016 Aug;64(2):370-80. doi: 10.1002/hep.28467. Epub 2016 Mar 22.
PMID: 26799692
citation: Lee SS, Bain VG, Peltekian K, Krajden M, Yoshida EM, Deschenes M, Heathcote J, Bailey RJ, Simonyi S, Sherman M; CANADIAN PEGASYS STUDY GROUP. Treating chronic hepatitis C with pegylated interferon alfa-2a (40 KD) and ribavirin in clinical practice. Aliment Pharmacol Ther. 2006 Feb 1;23(3):397-408. doi: 10.1111/j.1365-2036.2006.02748.x. Erratum In: Aliment Pharmacol Ther. 2006 Apr 1;23(7):1029.
PMID: 16422999
citation: Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001 Sep 22;358(9286):958-65. doi: 10.1016/s0140-6736(01)06102-5.
PMID: 11583749
citation: Pawlotsky JM. New hepatitis C therapies: the toolbox, strategies, and challenges. Gastroenterology. 2014 May;146(5):1176-92. doi: 10.1053/j.gastro.2014.03.003. Epub 2014 Mar 12.
PMID: 24631495
citation: Sharafi H, Alavian SM. IL28B polymorphism, Explanation for Different Responses to Therapy in Hepatitis C Patients. Hepat Mon. 2011 Dec;11(12):958-9. doi: 10.5812/kowsar.1735143X.794. Epub 2011 Dec 20. No abstract available.
PMID: 22368678
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responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Hazem shoman
investigator title: principle investigator
mesh term: Drug-Related Side Effects and Adverse Reactions
mesh term: Ritonavir
mesh term: Ribavirin
mesh term: Sofosbuvir