Clinical trial NCT03170076: Pattern of Skin Manifestations in Chronic Hepatitis c Virus Patients Before and After Direct Acting Anti Viral Drugs
Official title: Pattern of Skin Manifestations in Chronic Hepatitis c Virus Patients Before and After Direct Acting Anti Viral Drugs: Prospective Controlled Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C, Chronic
Keywords: skin manifestations - hepatitis c virus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patient are from assiut city

Brief summary: * Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver. It is one of the main causes of chronic liver diseases worldwide .
* According to World Health Organization (WHO), 2011 , Egypt has particularly high rates of Hepatitis C (22%).
* Hepatitis C virus (HCV) is known to induce both hepatic and extra-hepatic manifestations. About 17% of HCV patients present with at least one skin manifestation, which can be directly or indirectly induced by chronic HCV infection .

Detailed description: * Skin diseases which are certainly related with chronic HCV infection are mixed cryoglobulinemia, lichen planus , porphyria cutanea tarda, Chronic pruritus and necrolytic acral erythema; conditions that may share a possible association with HCV infection .
* while several immune-mediated inflammatory skin conditions, such as psoriasis, chronic urticaria and vitiligo, have been only rarely reported in the setting of chronic HCV infection .
* Peginterferon based regimen with or without ribavirin were the mainstay of HCV treatment with a cure rate of about 50%, Although these regimens were lengthy, complex, had significant side-effects and high failure rates .
* They also had higher rate of exacerbated dermatologic conditions such as discoid lupus, psoriasis and Lichen planus .
* Recently, Newer all-oral anti viral drugs regimens began to be approved for use in 2014. These regimens, involve one pill daily for 12 weeks, they have achieved sustained virologic response of over 90% and have more tolerable side effect profiles.
* Recently, The European Association for Study of Liver (EASL) 2015, American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) have now recommended that all chronically infected HCV patient should be offered treatment with new oral antiviral drugs .

Eligibility criteria: Inclusion Criteria:

1. Patients with HCV infection eligible for treatment with new (DAADs) and having:

   A- Normal Complete Blood Count ( hemoglobin not less than 10 gm/dl ). B- Mild to moderate impairment of Liver function test and kidney function test.

   C- Positive polymerase chain reaction for HCV virus. D- Controlled Blood sugar .
2. Patients \> 18 years

Exclusion Criteria:

1. Patients on treatment for skin disease.
2. Pregnancy and lactation.
3. Patients \<18 years.
4. Patients not eligible for oral anti hepatitis C drugs.

Primary outcomes:
measure: local skin examination
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Patel P, Malik K, Krishnamurthy K. Cutaneous Adverse Events in Chronic Hepatitis C Patients Treated With New Direct-Acting Antivirals: A Systematic Review and Meta-Analysis. J Cutan Med Surg. 2016 Jan;20(1):58-66. doi: 10.1177/1203475415595775. Epub 2015 Jul 10.
citation: Berk DR, Mallory SB, Keeffe EB, Ahmed A. Dermatologic disorders associated with chronic hepatitis C: effect of interferon therapy. Clin Gastroenterol Hepatol. 2007 Feb;5(2):142-51. doi: 10.1016/j.cgh.2006.06.010. Epub 2006 Aug 17.
citation: Strader DB, Wright T, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004 Apr;39(4):1147-71. doi: 10.1002/hep.20119. No abstract available.
citation: Cacoub P, Bourliere M, Lubbe J, Dupin N, Buggisch P, Dusheiko G, Hezode C, Picard O, Pujol R, Segaert S, Thio B, Roujeau JC. Dermatological side effects of hepatitis C and its treatment: patient management in the era of direct-acting antivirals. J Hepatol. 2012 Feb;56(2):455-63. doi: 10.1016/j.jhep.2011.08.006. Epub 2011 Aug 30.