DRUGS USED IN HEP C-ppt.pptx

drugs used in heptitis c

1. Drugs used in Hepatitis C Presenter –Noor Hasmee MSc nursing 2 nd year College of nursing Institute of liver and biliary sciences

2. HCV structure

3. HCV LIFE CYCLE https://youtu.be/QgZNfuxP0wM

4. HCV PROTEINS

5. Directly Acting Antivirals

6.   E fficacy of Direct acting antivirals In this analysis, we found DAA therapies to be effective, with 94% of the patients achieving SVR12 and 6% experiencing virologic failure. In a per-protocol analysis of 590 patients with SVR12 results, SVR12 was achieved in 540 (92%), and virological failure occurred in 50 (8%).    10.1371/journal.pone.0228847 https://doi.org/10.1093/cid/ciaa701

7. Elbasvir-Grazoprevir  ( Zepatier )

8. CLASS AND MECHANISM Elbasvir-grazoprevir is an oral fixed-dose combination of an NS5A replication complex inhibitor (elbasvir), and a “later”-generation HCV NS3/4A protease inhibitor (grazoprevir). Elbasvir is a small-molecule inhibitor of nonstructural protein 5A and possesses in vitro activity against most major HCV genotypes and some viral variants resistant to earlier NS5A inhibitors. Grazoprevir is a macrocyclic compound that reversibly binds to the HCV NS3/4A protease, an enzyme responsible for cleaving and processing the HCV-encoded polyprotein. 

9. INDICATIONS For persons with HCV and HIV-1 coinfection, the dosage and duration are the same as listed below. Elbasvir-Grazoprevir for Genotypes 1 or 4 (with or without cirrhosis) Genotype 1a, treatment-naïve or peginterferon/ribavirin-experienced* ( without  baseline NS5A polymorphisms^): Elbasvir-grazoprevir for 12 weeks Genotype 1a, treatment-naïve or peginterferon/ribavirin-experienced* ( with  baseline NS5A polymorphisms^): Elbasvir-grazoprevir plus ribavirin for 16 weeks 
Genotype 1b, treatment-naïve or peginterferon/ribavirin-experienced*: Elbasvir-grazoprevir for 12 weeks Genotype 1a #  or 1b, peginterferon/ribavirin/protease inhibitor-experienced + : Elbasvir-grazoprevir plus ribavirin for 12 weeks Genotype 4, treatment-naïve: Elbasvir-grazoprevir for 12 weeks Genotype 4, peginterferon/ribavirin-experienced*: Elbasvir-grazoprevir plus ribavirin for 16 weeks

10. DOSING The recommended dose is one tablet taken orally once daily, with or without food. No dosage adjustment is recommended for elbasvir-grazoprevir in patients with renal insufficiency, including patients with end-stage renal disease or persons on hemodialysis. For patients with mild hepatic impairment (Child-Pugh Class A), no dose adjustment of elbasvir-grazoprevir is recommended. Elbasvir-grazoprevir is contraindicated for use in patients with moderate to severe hepatic impairment (Child-Pugh Class B or C). When ribavirin is used with elbasvir-grazoprevir in patients with a CrCl greater than 50 mL/min, it should be given as weight-based dosing in two divided doses with food (weight less than 66 kg=800 mg/day; 66 to 80 kg=1000 mg/day; 81 to 105 kg=1200 mg/day; greater than 105 kg=1,400 mg/day).

11. CONTRAINDICATIONS ZEPATIER is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) due to the expected significantly increased grazoprevir plasma concentration and the increased risk of alanine aminotransferase (ALT) elevations ZEPATIER is contraindicated with inhibitors of organic anion transporting polypeptides 1B1/3 (OATP1B1/3) that are known or expected to significantly increase grazoprevir plasma concentrations, strong inducers of cytochrome P450 3A (CYP3A), and efavirenz If ZEPATIER is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen.

12. ADVERSE EFFECTS Based on pooled data from phase 2 and 3 trials (n = 834), the most common adverse reactions observed in persons receiving elbasvir-grazoprevir were fatigue (11%), headache (10%), and nausea (5%). Elevations in alanine aminotransferase levels (ALT) to greater than 5 times the upper limit of normal occurred in 1% of persons , typically occurring at or after 8 weeks of initiating therapy, with most resolving at or after the completion of therapy. To date, the rash and photosensitivity noted with earlier protease inhibitors has not been a problem in persons receiving elbasvir-grazoprevir.

13. Glecaprevir-Pibrentasvir   ( Mavyret )

14. CLASS AND MECHANISM Glecaprevir (GLE, formerly ABT-493) is an NS3/4A protease inhibitor that prevents the cleavage of the HCV polyprotein. Pibrentasvir (PIB, formerly ABT-530) is a next-generation NS5A inhibitor; it maintains potent antiviral activity against common HCV NS5A single-position variants that confer resistance to first-generation NS5A inhibitors, including daclatasvir, ledipasvir, and ombitasvir .

15. INDICATIONS The 8-week course of glecaprevir-pibrentasvir is indicated for treatment-naïve persons with genotypes 1-6 HCV, including individuals without cirrhosis and those with compensated cirrhosis (Child-Pugh A). For treatment-experienced persons, the treatment course varies from 8 to 16 weeks, based on HCV genotype, the prior treatment regimen, and cirrhosis status. DOSING Each fixed-dose tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir . The recommended oral dosage of glecaprevir-pibrentasvir in adults is 3 tablets taken at the same time once daily with food (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg).

16. CONTRAINDICATIONS MAVYRET is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation  MAVYRET is contraindicated with atazanavir or rifampin

17. Ledipasvir-Sofosbuvir  (Harvoni)

18. CLASS AND MECHANISM Ledipasvir is a potent inhibitor of HCV NS5A, a viral phosphoprotein that plays an important role in viral replication, assembly, and secretion. Sofosbuvir is a nucleotide analog inhibitor of hepatitis C virus NS5B polymerase—the key enzyme mediating HCV RNA replication. The triphosphate form of sofosbuvir (GS-461203) mimics the natural cellular uridine nucleotide and is incorporated by the HCV RNA polymerase into the elongating RNA primer strand, resulting in viral chain termination.

19. INDICATIONS Genotype 1 Treatment-naïve patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) : ledipasvir-sofosbuvir x 12 weeks* Treatment-experienced** patients without cirrhosis: ledipasvir-sofosbuvir x 12 weeks Treatment-experienced** patients with compensated cirrhosis (Child-Pugh A): ledipasvir-sofosbuvir x 24 weeks † Treatment-naïve and treatment-experienced** patients with decompensated cirrhosis (Child-Pugh B or C): ledipasvir-sofosbuvir plus ribavirin ‡  x 12 weeks Genotype 1 or 4 Treatment-naïve and treatment-experienced ** liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh A): ledipasvir-sofosbuvir plus ribavirin §  x 12 weeks Genotype 4, 5, or 6 Treatment-naïve and treatment-experienced ** patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): ledipasvir-sofosbuvir plus ribavirin x 12 weeks

20. DOSING Ledipasvir-sofosbuvir (90 mg/400 mg) is a fixed-dose combination tablet. The recommended dosage is one tablet once daily, with or without food. For patients with any degree of renal impairment including end-stage renal disease requiring dialysis, no dosage adjustment is necessary. For patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C), no dosage adjustment is recommended

21. Ribavirin  ( Copegus , Rebetol , Ribasphere )

22. CLASS AND MECHANISM Ribavirin is a purine nucleoside analog that has an incompletely understood mechanism of action against hepatitis C virus. Investigators have proposed four main potential sites of ribavirin action against hepatitis C virus: augmentation of host T-cell immune clearance of HCV, inhibition of the host enzyme inosine monophosphate dehydrogenase (IMPDH) that results in depleted pools of guanosine triphosphate, an essential substrate for viral RNA synthesis direct inhibition of HCV replication, and induction of RNA virus mutagenesis that drives HCV to an abonormally high error rate.

23. INDICATIONS Ribavirin should never be used as monotherapy for the treatment of hepatitis C virus. For all preparations, ribavirin is contraindicated in (1) pregnant women and male partners of females who are pregnant, (2) patients with hemoglobinopathies, and (3) coadministration with didanosine ( Videx ).

24. DOSIng Ribavirin is available in 200 mg, 400 mg, 500 mg, and 600 mg capsules and tablets.  In addition, ribavirin is available in an oral (liquid) solution. The availability of specific strength depends on the brand of the ribavirin.  Ribavirin ( Copegus ) is available in 200 mg tablets and should be taken with food. The daily dose when given as fixed dosing is 800 mg per day in two divided doses.   When given as weight-based, the dose is 1000 mg/day for persons less than 75 kg and 1200 mg/day for those 75 kg or greater.   Ribavirin ( Rebetol ) is available in 200 mg capsules and oral solution (40 mg/ml) taken with food. The daily dose of ribavirin ranges from 800 to 1400 mg given in two divided doses.  The daily dose when given as fixed dosing is 800 mg in two divided doses.  When given as weight-based, the dose is 800 mg/day for body weight less than 66 kg, 1000 mg/day for 66 to 80 kg, 1200 mg/day for 81 to 105 kg, and 1400 mg/day for those greater than 105 kg; in all instances, the ribavirin is given in two divided doses.  

25. The levels of ribavirin increase significantly in patients with renal insufficiency. Patients with a creatinine clearance 30 to 60 mL/min have a twofold increase in ribavirin area under the curve (AUC) and those with a creatinine clearance 10 to 30 mL/min have a threefold increase in ribavirin AUC. Ribavirin is not significantly removed by dialysis. Ribavirin requires dosage modification in patients who have a creatinine clearance less than 50 mL/min and the exact dosage adjustment should be made based on the prescribing information for the specific brand of ribavirin used.    Ribavirin levels are not significantly impacted by mild, moderate, or severe hepatic dysfunction. 

26. ADVERSE EFFECTS Two potentially serious ribavirin-associated adverse effects are listed as black box warnings. Hemolytic Anemia:  Ribavirin can cause a potentially severe hemolytic anemia. The hemolytic anemia can occur suddenly and can result in worsening of cardiac disease, even leading to myocardial infarction. The hemolytic anemia most often occurs within 1 to 2 weeks after starting therapy. Accordingly, patients should have a hematocrit and/or hemoglobin checked prior to starting therapy and at week 2 and 4 of therapy. Birth Defects: Ribavirin can cause significant teratogenic and embyocidal effects, including potential birth defects and fetal death.  Ribavirin should not be used by women during pregnancy or in male partners of women who are pregnant.  For women who will receive treatment with ribavirin, a documented negative pregnancy test is required immediately prior to starting ribavirin therapy and women should use two or more forms of birth control and have monthly pregnancy testing during treatment and for 6 months thereafter. Further, pregnancy should be avoided for at least 6 months after completing ribavirin therapy (for females who have taken ribavirin and for females partners of males who have taken ribavirin).  

27.  CONTRAINDICATIONS COPEGUS (ribavirin) is contraindicated in: Women who are pregnant. COPEGUS may cause fetal harm when administered to a pregnant woman. COPEGUS is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus Men whose female partners are pregnant. Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia). In combination with didanosine . Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials  COPEGUS and PEGASYS combination therapy is contraindicated in patients with: Autoimmune hepatitis. Hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before treatment  Hepatic decompensation (Child-Pugh score greater than or equal to 6) in cirrhotic CHC patients coinfected with HIV before treatment 

28. Sofosbuvir  (Sovaldi)

29. CLASS AND MECHANISM Sofosbuvir is a nucleotide analog inhibitor of hepatitis C virus NS5B polymerase—the key enzyme mediating HCV RNA replication.

30. INDICATIONS Sofosbuvir is indicated for treatment of patients with chronic HCV Genotype 1 or 4: sofosbuvir plus peginterferon-alfa plus ribavirin for 12 weeks Genotype 2: sofosbuvir plus ribavirin for 12 weeks Genotype 3: sofosbuvir plus ribavirin for 24 weeks For the treatment of patients with HCV-HIV-1 coinfection: the recommendations are the same as listed above. For patents with genotype 1 HCV who are not eligible to receive interferon: sofosbuvir plus ribavirin for 24 weeks can be considered. For patients with HCV and hepatocellular carcinoma awaiting liver transplantation: sofosbuvir plus ribavirin for a duration of up to 48 weeks or until liver transplantation, whichever occurs first.

31. DOSING Sofosbuvir is available as a 400 mg tablet. The recommended dose of sofosbuvir is 400 mg taken orally once daily, with or without food. The 400 mg dose of sofosbuvir should be used, regardless of the patient's genotype and prior hepatitis C treatment experience. No dose adjustment is needed for mild-to-moderate renal impairment or with mild, moderate, or severe hepatic impairment. The prescribing information does not make a recommendation for dosing in patients who have severe renal impairment (eGFR less than 30 ml/min/1.73m 2 ) or end stage renal disease requiring dialysis. Sofosbuvir is also available as a fixed-dose combination pill (ledipasvir 90 mg and sofosbuvir 400 mg) taken once daily.

32. Sofosbuvir- velpatasvir

33. CLASS AND MECHANISM Sofosbuvir- velpatasvir is an oral fixed-dose combination of sofosbuvir, a nucleotide analog NS5B polymerase inhibitor and velpatasvir , an NS5A replication complex inhibitor. Sofosbuvir is currently approved in the United States for the treatment of HCV genotypes 1-6 HCV. Velpatasvir (formerly GS-5816) is a novel NS5A inhibitor that has potent in vitro anti-HCV activity across all genotypes at the picomolar level. The combination of sofosbuvir- velpatasvir is the first once-daily single-tablet regimen with pangenotypic activity.

34. INDICATIONS The fixed-dose combination sofosbuvir- velpatasvir (400 mg/100 mg) is FDA-approved for the treatment of chronic hepatitis C genotypes 1 to 6 for the following patient populations: Patients without cirrhosis and patients with compensated cirrhosis (Child-Pugh A): sofosbuvir- velpatasvir for 12 weeks Patients with decompensated cirrhosis (Child-Pugh B and C): sofosbuvir- velpatasvir plus ribavirin for 12 weeks

35. DOSING Sofosbuvir- velpatasvir is available as a coformulated , once-daily single-pill combination of sofosbuvir 400 mg and velpatasvir 100 mg. The recommended dose is one tablet once daily, taken with or without food. Renal Impairment: No dosage adjustment is recommended in patients with any degree of renal impairment including patients with end-stage renal disease on dialysis. The updated recommendation for dosing n persons with renal impairment was based on safety and pharmacokinetic data from mostly observational studies. Hepatic Impairment: For patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C), no dosage adjustment for sofosbuvir- velpatasvir is recommended. For patients with decompensated cirrhosis who are receiving sofosbuvir- velpatasvir and ribavirin, clinical and laboratory monitoring is recommended.

36. CONTRAINDICATIONS EPCLUSA and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. 

37. Daclatasvir

38. CLASS AND MECHANISM Daclatasvir was discovered as a first-in-class inhibitor of the non-structural viral protein 5A (NS5A), a phosphoprotein that plays an important role in hepatitis C replication. The exact mechanism by which daclatasvir inhibits the NS5A replication complex is unclear, but it is believed that daclatasvir inhibits viral RNA replication and virion assembly. It may also inhibit phosphorylation of the NS4A, and therefore the formation and activation of the HCV replication complex.

39. INDICATIONS Daclatasvir is indicated for use, with sofosbuvir, with or without ribavirin for the treatment of patients with chronic HCV genotype 1 or 3. The use of ribavirin depends on the patient population treated as outlined below. For patients with HCV/HIV-1 coinfection, the dosage and duration are the same as listed below. Genotype 1 Genotype 1, without cirrhosis: daclatasvir plus sofosbuvir for 12 weeks Genotype 1, compensated (Child-Pugh A) cirrhosis*: daclatasvir plus sofosbuvir for 12 weeks Genotype 1, decompensated (Child-Pugh B or C) cirrhosis*^: daclatasvir plus sofosbuvir plus ribavirin for 12 weeks Genotype 1, post-transplant: daclatasvir plus sofosbuvir plus ribavirin for 12 weeks

40. INDICATIONS *For patients with genotype 1a and cirrhosis, consider screening for the presence of baseline NS5A resistance-associated polymorphisms at amino acid positions 28, 30, 31, or 93 prior to initiating treatment. ^For HCV genotype 1 patients with Child-Pugh C cirrhosis, the optimal duration of therapy with daclatasvir plus sofosbuvir plus ribavirin has not been established Genotype 3 Genotype 3, without cirrhosis: daclatasvir plus sofosbuvir for 12 weeks Genotype 3, compensated (Child-Pugh A) or decompensated (Child-Pugh B or C) cirrhosis: daclatasvir plus sofosbuvir plus ribavirin for 12 weeks Genotype 3, post-transplant: daclatasvir plus sofosbuvir plus ribavirin for 12 weeks # For HCV genotype 3 patients with cirrhosis the optimal duration of therapy with daclatasvir plus sofosbuvir, with or without ribavirin, has not been established. NOTE: For the use of dasabuvir and sofosbuvir in genotype 3 patients with cirrhosis, the AASLD/IDSA guidance recommends 24 weeks of therapy, with or without ribavirin.

41. Daclatasvir Daclatasvir is available as a 60 mg tablet (light green in color) and 30 mg tablet (green in color) The recommended standard dose of daclatasvir is 60 mg orally once daily, with or without food. The recommended dose of sofosbuvir, when used with daclatasvir is 400 mg once daily, with or without food. The daclatasvir levels are expected to decrease and need to be adjusted in patients with any degree of renal impairment. In addition, because daclatasvir is highly protein bound, it is unlikely to be removed by dialysis. Patients with Hepatic Impairment: No dose adjustment is recommended for hepatic impairment, including patients with mild (Child-Pugh A), moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment

42. Recommended Ribavirin Dosing When ribavirin is used in patients with HCV genotype 1 or 3 and either Child-Pugh B or C cirrhosis or post-transplantation patients, the recommended initial dose of ribavirin is 600 mg once daily, increasing up to 1000 mg daily as tolerated. In this scenario, the ribavirin starting dose and on-treatment dose can be decreased based on hemoglobin and creatinine clearance. When ribavirin is used in combination with daclatasvir and sofosbuvir in patients with HCV genotype 3 and compensated cirrhosis (Child-Pugh A), the recommended ribavirin dose is weight based (1000 mg for patients weighing less than 75 kg and 1200 mg for those weighing at least 75 kg) and is administered in two divided doses.

43. CLINICAL USE The primary use for daclatasvir, at present, will be in combination with sofosbuvir, with or without ribavirin, for treatment-naïve and treatment-experience patients with chronic HCV genotype 1 or 3 infection, including those with cirrhosis and those with HIV coinfection. This regimen is the only FDA-approved all-oral 12-week regimen for the treatment of genotype 3 infection and regimen is a once-daily regimen. The regimen of daclatasvir plus sofosbuvir plus ribavirin will likely be a preferred option for treating patients post-liver transplantation.

44. FDA STATUS On July 24, 2015, the United States Food and Drug Administration (FDA) initially approved daclatasvir for use with sofosbuvir for the treatment of chronic HCV genotype 3 infection. In February 2016, the FDA modified and expanded the daclatasvir indications—daclatasvir is now indicated for use with sofosbuvir, with or without ribavirin, for patients with chronic HCV genotype 1 or 3. The new indications also include approval for use in patients with HIV-1 infection, those with decompensated cirrhosis, and following liver transplantation.   DOI:  10.3851/IMP3278

45. Treatment of HIV and HCV Co-infection It is advisable to first initiate treatment for HIV and achieve HIV suppression before starting HCV treatment, although there are some circumstances where it may make sense to treat HCV infection first and then initiate therapy for HIV. This could include persons with moderate-to-severe fibrosis at risk of rapid liver disease progression if the HIV infection is not associated with significant immunosuppression at the time of treatment.

46. Persons with HBV/HCV co-infection It is important to check for the presence of HBV infection before starting HCV treatment. HBV and HCV co-infection may result in an accelerated disease course; HCV is considered to be the main driver of disease. Persons co-infected with HBV and HCV can be treated with antiviral therapy for HCV; SVR rates are likely to be similar to those in HCV-mono infected persons. During treatment and after HCV clearance, there is a risk of reactivation of HBV, and this may require treatment with concurrent anti-HBV antiviral therapy.

47. Persons with TB/HCV co-infection People at increased risk of infection with HCV are also often at increased risk of infection with TB. Therefore, screening for active TB should be part of the clinical evaluation of patients being considered for HCV treatment. If the patient does not have any one of the following symptoms – current cough, fever, weight loss or night sweats – TB can be reasonably excluded; otherwise, the patient should undergo further investigations for TB or other diseases. Most of the DAAs interact with metabolic pathways in the liver, which increases and/or decreases the drug level of DAAs when co-administered with antimicrobial medicines such as rifabutin, rifampin and rifapentine. Therefore, concurrent treatment of HCV infection and TB should be avoided. Active TB should generally be treated before commencing therapy for HCV. Furthermore, in persons with HCV infection being treated for TB, it is important to monitor liver function tests, as the risk of anti-mycobacterial -induced hepatotoxicity is

48. Contd … higher in patients with TB/HCV co-infection than in those with TB mono infection, although the risk of severe hepatotoxicity is rare. Concurrent treatment of HCV infection and multidrug-resistant TB is particularly complicated because of many DDIs between DAAs and second-line antimicrobials. There are limited data on the management of persons coinfected with HCV, HIV and TB, but such cases need sound clinical judgement in order to reduce the additive side-effects, pill burden and DDIs. Baseline liver function tests for individuals with chronic liver disease are encouraged prior to initiating treatment for latent TB infection. For individuals with abnormal baseline test results, routine periodic laboratory testing should be carried out during the treatment of latent TB infection.

49. An Investigation of the Side Effects, Patient Feedback, and Physiological Changes Associated with Direct-Acting Antiviral Therapy for Hepatitis C   Aim T o investigate the subjective reports of discomfort, patient feedback about the course of treatment, and physiological changes after DAA treatment in HCV patients.  Methods:  A descriptive, prospective, comparative cohort study was conducted from January to August 2019 in , Taiwan. Results:  Six-hundred-and-twenty-three participants with an active HCV infection were identified; 555 (89.1%) had completed treatment, and sustained virologic response was achieved in 99.6% (n = 553). The mean age was 64.9 (standard deviation = 13.1) years, and 35% of patients experienced discomfort during DAA treatment, including fatigue, itching, and dizziness. After three months of treatment, physiological markers, including body weight ( p  < 0.001), waist circumference ( p  < 0.05), blood pressure ( p  < 0.001), alanine aminotransferase ( p  < 0.001), and aspartate aminotransferase ( p  < 0.001), had significantly improved. Almost all participants provided positive feedback about the treatment experience and reported manageable side effects.   Conclusions:  The findings showed that, in an endemic rural area, DAA treatment had a high cure rate and improved physiological markers with few discomforts. These results can be used to reduce the barriers HCV patients face in adopting new medications.  

50. Side Effects of Treatment in patients with Hepatitis C- implications for Nurse Specialist Practice Objective: To identify patients' perceptions of the side effects of Hepatitis C treatment. Design: The research used a self-reporting postal survey design to identify reported side effects, related to hepatitis C treatment, suffered by patients attending a specialist nurse clinic. Setting: The setting for this study was an outpatient hepatology clinic in a large general hospital in Ireland. Subjects: The questionnaire was distributed to a convenience sample of 201 patients receiving hepatitis C treatment at the hospital. Main outcome measure(s): To determine what side effects are most common during hepatitis C treatment; to identify whether or not patients are satisfied with the nurse specialist/nurse led service and to identify the unmet support needs of patients on treatment. Results: Several side effects were reported, including fatigue, sleep disturbances and weight loss. Another high scoring side effect was sexual dysfunction. Patients reported a high satisfaction with nurse specialist services. Conclusions: Manifestations of treatment have implications for care management of this group. Routine assessment of quality of life or symptom related needs is suggested in addition to personalised support from nurse specialists. Raising patients' awareness of the potential side effects is very important in the approach to care, particularly in relation to compliance. In addition, providing information and advice to patients about how to manage their symptoms is essential.

51. Case report Sofosbuvir and daclatasvirto treat a patient with acute hepatitis C virus genotype 2 monoinfection Rationale: Direct-acting antivirals (DAAs) are the first-line treatment for patients with chronic hepatitis C virus (HCV) infection. However, its effects on patients with acute HCV infection are poorly understood, and the data for treatment of DAAs for genotype 2 acute monoinfection patients with HCV are lacking. Patient concerns : In this case report, a 26 year-old Chinese female acquired a tattoo and developed fatigue, nausea, and anorexia. Laboratory tests showed abnormal liver function. Diagnoses: Five months after the patient acquired a tattoo, laboratory tests showed anti-HCV antibody titers were 26.0 s/co, HCV RNA was 5.74×10 5  IU/mL, and HCV genotype was 2a. The patient was diagnosed with acute hepatitis C (AHC). Interventions: HCV RNA did not have spontaneous clearance 12 weeks after the infection of the patient. The patient received sofosbuvir (SOF) and daclatasvir (DCV) combination treatment for 12 weeks. Outcomes: Laboratory tests showed HCV RNA was undetectable at weeks 4, and anti-HCV antibody was in seroconversion at weeks 12 during treatment. The patient achieved a sustained virological response 36 weeks after the end of treatment.

52. Nursing considerations Counselling Teach about the disease process, prevention. Encourage to adapt barrier methods while having sexual intercourse Teach the importance of medication and not to skip any doses. Visit hospital for routine follow-up and visit in case of emergencies. Encourage to have a good nutrition and not to wear crowded places,avoid using same razors,nail cutter etc…