Treatment of HCV in the Era of DAAs in Pakistan

Transcription

1 PSH Clinical Guidelines Statement 2017 Treatment of HCV in the Era of DAAs in Pakistan Prof. Altaf Alam Professor of Gastroenterology-Hepatology Shaikh Zayed Postgraduate Medical Institute, Lahore. Pakistan ABSTRACT In Pakistan, with 4.9% HCV prevalence and the 2 nd largest burden of patients worldwide, it is a challenging task to meet the WHO targets to eliminate the disease by It will require effective steps to prevent new cases, diagnose existing patients and treat them all with effective DAAs appropriately. Important steps in the management of HCV patients are counseling, evaluation of disease status including previous antiviral therapy, viral genotype, use of DAAs for appropriate duration and careful monitoring during therapy. Post-treatment follow-up especially surveillance for hepatocellular carcinoma is mandatory in patients with advanced fibrosis (F3) and cirrhosis (F4). This paper covers treatment of Genotype 1 and 3 only with the available drugs in Pakistan. INTRODUCTION Hepatitis C is a global health problem with approximately 160 million infected persons worldwide. In Pakistan, prevalence of HCV is 4.9% with regional variations and the 2 nd largest burden of patients worldwide. In Pakistan more than 90% of HCV is Genotype 3 with most of the rest Genotype 1. Genotypes 2,4,5,6 are rarely seen in our country. Over the last 4 years we have witnessed a revolution in the treatment of HCV with the availability of many Directly Acting Antivirals (DAAs). These drugs are very effective, well tolerated, but the cost and availability still remains a problem. In Pakistan, sofosbuvir (Sovaldi) first became available in 2014 at a compassionate price of USD 3000 by Gilead and reduced further to USD 1000 now for a 24-week course of treatment. Moreover, generic sobosbuvir is now available in Pakistan for more than a year and generic daclatasvir will soon be available. Daclatasvir has also been available in Pakistan for almost 2 years but it is still not registered in Pakistan. Moreover, Epclusa and Harvoni are available in Pakistan at a compassionate price by Gilead. This paper covers the management of HCV in Pakistan under following headings: 1. Screening and diagnosis 2. Counseling of patients 3. Treatment of Genotype 1 and 3 4. Drug-drug interactions 5. Follow-up during treatment 6. Follow-up after treatment The use of following drugs will be discussed only these drugs are available in Pakistan: Page 1 of 5

2 1. Sofosbuvir(Sovaldi and generics) 2. Daclatasvir(Generic from India) 3. Sofosbuvir+velpatasvir(Epclusa) 4. Sofosbuvir+ledipasvir(Harvoni) SCREENING & DIAGNOSIS Screening test- Anti-HCV by Elisa Confirmatory test- HCV RNA by PCR or HCV Core Antigen Additional tests prior to treatment: HCV Genotype HBsAg, HIV (in high risk behavior patients only) CBC, INR LFTs, Albumin, Serum Creatinine (egfr), Serum Sodium US Abdomen APRI Score (>1=F3,F4. Use APRI calculator on net or QxMD App on smartphone) or Transient Elastography (Fibroscan/Shear-wave elastography) Alpha-fetoprotein Upper GI Endoscopy (if indicated) DRUG-DRUG INTERACTIONS Refer to University of Liverpool website- Or Refer to University of Liverpool smartphone App-Liverpool HEP ichart TREATMENT OF GENOTYPE-3 Treatment-Naïve non-cirrhotic 1.SOF 400mg+DCV 60mg-12 weeks 2.SOF 400mg+DCV 60mg-12 weeks 3.SOF 400mg+RBV MG-24 weeks Treatment-Naïve cirrhotic 2.SOF400mg+VEL 100mg+ RBV mg-12 weeks Treatment-Experienced non-cirrhotic 1.SOF 400mg+DCV 60mg+RBV mg-12 weeks 2.SOF 400mg+VEL 100mg+RBV mg-12 weeks Treatment-Experienced cirrhotic Page 2 of 5

3 2.SOF 400mg+VEL 100mg+RBV mg-12 weeks (24 weeks if no RBV) Decompensated Cirrhosis 2.SOF 400mg+VEL 100mg+RBV mg-24 weeks TREATMENT OF GENOTYPE-1 Treatment-Naïve non-cirrhotic 1. SOF 400mg+LDV 90mg-12 weeks 2. SOF 400mg+VEL 100mg-12 weeks 3. SOF 400mg+DCV 60mg-12 weeks Treatment-Naïve cirrhotic 1. SOF 400mg+LDV 90mg-12 weeks 2. SOF 400mg+VEL 100mg-12 weeks 3. SOF 400mg+DCV 60mg-12 weeks Treatment-Experienced non-cirrhotic 1. SOF 400mg+LDV 90mg-12 weeks (Genotype 1b) 2. SOF 400mg+LDV 90mg+RBV mg-12 weeks (Genotype 1a; 24 weeks if no RBV) 3. SOF 400mg+VEL 100mg-12 weeks 4. SOF 400mg+DCV 60mg-12 weeks (Genotype 1b) 5. SOF 400mg+DCV 60mg+RBV mg-12 weeks (Genotype 1a; 24 weeks if no RBV) Treatment-Experienced cirrhotic 1. SOF 400mg+LDV 90mg-12 weeks (Genotype 1b) 2. SOF 400mg+LDV 90mg+RBV mg-12 weeks (Genotype 1a; 24 weeks if no RBV) 3. SOF 400mg+VEL 100mg-12 weeks 4. SOF 400mg+DCV 60mg-12 weeks (Genotype 1b) 5. SOF 400mg+DCV 60mg+RBV mg-12 weeks (Genotype 1a; 24 weeks if no RBV) Decompensated cirrhosis 1. SOF 400mg+LDV 90mg+RBV mg-12 weeks (24 weeks if no RBV) 2. SOF 400mg+VEL 100mg+RBV mg-12 weeks (24 weeks if no RBV) 3. SOF 400mg+DCV 60mg+RBV mg-12 weeks (24 weeks if no RBV) Adjustment of RBV dose in CKD egfr>50ml/min egfr 30-50ml/min 1000 mg upto 75 kg. Body weight 1200 mg > 75 kg.body weight 400mg alternating with 200mg/day Page 3 of 5

4 egfr 15-30ml/min egfr <15ml/min or Hemodialysis 200mg/day 200mg/day FOLLOW-UP OF PATIENTS During Treatment with DAAs 1. First follow-up 2 weeks after start of treatment with CBC, Creatinine and LFTs. 2. Second and subsequent follow-ups every 4weeks with CBC, Creatinine and LFTs till the treatment finishes. 3. HCV RNA by PCR (Qualitative) or HCV Core Antigen test week 4 and end of treatment. Nonavailability of these viral markers should not be a bar to treatment. 4. HCV RNA by PCR (Qualitative) or HCV Core Antigen test week 12 and weeks after end of treatment to assess SVR. Follow-up after treatment with DAAs for those who achieved SVR 1. Patients with no advanced fibrosis( F0- F2) may be discharged after SVR12 and SVR Screening for HCC for F3, F4 3. Endoscopoic screening for esophageal varices in cirrhotics 4. Assessment for reinfection/recurrence in patients with ongoing risk for HCV infection Follow-up after treatment with DAAs for those who did not achieve SVR 1. Disease progression assessment every 6 months 2. Screening for HCC for F3, F4 3. Endoscopoic Screening for esophageal varices in cirrhotics 4. Evaluation for retreatment as effective alternative treatments become available Page 4 of 5

5 REFRENCES 1. Qureshi H., Bile KM, Jooma R, Alam SE, Afridi HU. Prevalence of hepatitis B and C viral infection in Pakistan: findings of a national survey appealing for effective prevention and control measures. East Mediterr Health J. 2010;16 Suppl: S EASL Recommendations on Treatment of Hepatitis C Page 5 of 5