Hepatitis C: Module Options for genotype 1a and 1b pros and cons

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1 Drug Regimen HCV genotype Pros Cons Sofosbuvir 400mg + ledipasvir 90mg, orally, Sofosbuvir 400mg, orally, + daclatasvir 60mg, orally Elbasvir 50mg + grazoprevir 100mg, orally Once- single pill regimen. Generally well tolerated, potential side effects are generally mild and include: fatigue, headache, diarrhoea, insomnia, rash and nausea. mild, moderate and severe hepatic impairment. Simple regimen (2 pills once a day). Combination generally well tolerated, potential side effects are generally mild and include: fatigue, headache, diarrhoea, insomnia, nausea and possible increased ALT and AST levels. mild, moderate and severe hepatic impairment. Once- single pill regimen. Generally, well tolerated, potential side effects are generally mild and include: fatigue, headache, diarrhoea, insomnia, rash and nausea. Safety and efficacy has not been established in patients with decompensated cirrhosis and is therefore contraindicated in these patients. Safety and efficacy has not been established in patients with decompensated cirrhosis and is therefore contraindicated in these patients. Contraception required during and for five weeks afterwards. May cause liver inflammation, jaundice and ALT elevations: Perform hepatic laboratory testing prior to therapy, at treatment week 8, and as clinically indicated. For patients receiving 16 weeks of therapy, perform additional hepatic laboratory testing at treatment week 12. For ALT elevations, follow recommendations in full prescribing information.

2 Sofosbuvir 400mg + velpatasvir 100mg, orally, Paritaprevir-ritonavir (150/100mg), orally, + ombitasvir 25mg, orally + dasabuvir 250mg, orally twice any degree of renal impairment. 1a/1b Once- single pill regimen. Generally, well tolerated, potential side effects are generally mild and include: headache, fatigue, nausea and nasopharyngitis. 1b SVR 95% for 1b without ribavirin. Combination generally well tolerated, potential side effects include: nausea, pruritus, insomnia, ALT level rises and transient hyperbilirubinaemia. No dose adjustment is necessary for patients with any degree of renal impairment. Simple packaging assists with adherence. Contraindicated in moderate to severe hepatic impairment (Child-Pugh B and C). In patients with genotype 1a, who have previously failed treatment combination with ribavirin is required. In patients with decompensated cirrhosis (Child-Pugh B and C) addition of ribavirin is required. Insufficient patients enrolled in key studies to detect uncommon adverse effects. More complex regimen. Patients required to take multiple tablets morning and night. Not recommended for prior non-responders to protease inhibitor therapy. Requires discontinuation of ethinyl estradiol containing medicines (alternative contraception required). Adverse effects include: nausea, pruritus, insomnia, ALT level rises and transient hyperbilirubinaemia. Contraindicated in moderate to severe hepatic impairment (Child-Pugh B and C).

3 Sofosbuvir 400mg, orally, + daclatasvir 60mg, orally, + ribavirin 1000/1200mg*, orally, (in two divided doses) Addition of ribavirin required in patients with cirrhosis (specialist management required). More complex regimen. Patients required to take multiple tablets morning and night. The addition of ribavirin: 1. Increases the frequency of adverse reactions, including: anaemia, neutropenia, insomnia, irritability, fatigue, dizziness, myalgia, cough and nasal congestion. 2. Requires dose reduction in patients with CrCl less than 50mL/min. 3. Requires patients with renal dysfunction to undergo intensive monitoring of haemoglobin. 4. Restricts regimen to patients with Child-Pugh score A. 5. Has additional contraindications including: A history of severe, pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous 6 months. Haemoglobinopathies (such as thalassaemia and sickle cell anaemia). Males with Hb <130g/L and females with <110g/L. 6. Means that drug interactions may occur for up to two months after stopping treatment (due to long half-life).

4 Paritaprevir-ritonavir (150/100mg), orally, + ombitasvir 25mg, orally + dasabuvir 250mg, orally twice + ribavirin 1000/1200mg, orally, (in two divided doses) 1a SVR 95% for treatment of genotype 1a with ribavirin. Simple packaging assists with adherence. 7. Makes this regimen category X: negative pregnancy test required before initiating treatment contraindicated in men with pregnant partners. Two forms of contraception are recommended for both men and women during treatment and for six months after treatment. More complex regimen. Patients required to take multiple tablets morning and night. Not recommended for prior non-responders to protease inhibitor therapy. Requires discontinuation of ethinyl estradiol containing medicines (alternative contraception required). Adverse effects include: nausea, pruritus, insomnia, ALT level rises and transient hyperbilirubinaemia. The addition of ribavirin: 1. Increases the frequency of adverse reactions, including: anaemia, neutropenia, insomnia, irritability, fatigue, dizziness, myalgia, cough and nasal congestion. 2. Requires dose reduction in patients with CrCl less than 50mL/min. 3. Requires patients with renal dysfunction to undergo intensive monitoring of haemoglobin. 4. Restricts regimen to patients with Child-Pugh score A. 5. Has additional contraindications including:

5 * Ribavirin dosing is weight-based, 1000mg, people <75kg and 1200mg, people 75kg A history of severe, pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous 6 months. Haemoglobinopathies (such as thalassaemia and sickle cell anaemia). Males with Hb <130g/L and females with <110g/L. 6. Means that drug interactions may occur for up to two months after stopping treatment (due to long half-life). 7. Makes this regimen category X: negative pregnancy test required before initiating treatment, contraindicated in men with pregnant partners. Two forms of contraception are recommended for both men and women during treatment and for six months after treatment.

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