New Drug Update 2016 Joe Strain, Pharm.D. SDSU College of Pharmacy

New Drug Update 2016 Joe Strain, Pharm.D. SDSU College of Pharmacy
Rapid City Regional Hospital

Learning Objectives Upon successful completion of this activity, the audience should be able to: Identify therapeutic indications of drugs recently approved by the FDA. Discuss pharmacological properties of the new medications List side effects, warnings, precautions and significant drug interactions associated with each medication. Identify the normal dose and dosage forms of the drugs presented. Describe limitations to implementing the new medications into clinical practice

New Drug Approval Trends
NME: New Molecular Entity NB: New Biologic

Agenda Edoxaban (Savaysa™) Idarucizumab (Praxbind®)
Sacubitril/valsartan (Entresto™) Alirocumab (Praluent®) Evolocumab (Repatha™) Flibanserin (Addyi™) Insulin degludec (Tresiba™) Naloxegol (Movantik™) Eluxadoline (Viberzi™) Hepatitis C drug updates Ceftazidime/avibactam (Avycaz®) Ceftolozane/tazobactam (Zerbaxa™)

Edoxaban (Savaysa™) Indication Pharmacology
Reduce stroke and systemic embolism in non-valvular atrial fibrillation Treatment of DVT & PE AFTER days of a parenteral anticoagulant Pharmacology Factor Xa inhibitor Savaysa PI 2015.

Pharmacokinetic comparison of oral Factor Xa inhibitors
Edoxaban Apixaban Rivaroxaban Peak effect 1-2h 3-4h 2-4h T ½ 10-14h ~ 12h 5-9h Renal clearance 50% ~ 27% ~ 36% Metabolism Minimal CYP3A4 Savaysa PI 2015. Eliquis PI 2012. Xarelto PI 2014.

Edoxaban (Savaysa™) Warnings and precautions
Not recommended in mechanical heart valves or moderate to severe mitral stenosis Not recommended for use in non- valvular atrial fibrillation IF the creatinine clearance is > 95 ml/min Not studied in CrCl < 15 ml/min Savaysa PI 2015

Edoxaban (Savaysa™) Drug interactions P-glycoprotein inhibitors
May require reduction for DVT/PE indication P-glycoprotein inducers (i.e. rifampin) Avoid due to reduced levels Other anticoagulants and antiplatelets Savaysa PI 2015.

Bleeding Rates in Atrial Fibrillation with CrCl < 95 ml/min
Bleeding Event Edoxaban 60 mg n = 5417 Warfarin n = 5485 HR (95% CI) Major 3.1% 3.7% 0.84 (0.73,0.97) Intracranial hemorrhage 0.5% 1% 0.44 (0.32, 0.61) GI bleeding 1.8% 1.3% 1.4 (1.13, 1.73) Fatal bleeding 0.2% 0.4% 0.51 (0.3, 0.86) Savaysa PI 2015.

Bleeding Rates in VTE Bleeding Event Edoxaban 60 mg N = 4118 Warfarin
HR (95% CI) Clinically Relevant bleeding 8.5% 10.3% 0.81 (0.71, 0.94) Major bleeding 1.4% 1.6% 0.84 (0.59, 1.21) Intracranial hemorrhage 0.1% 0.3% NR Fatal bleeding < 0.1% 0.2% N Engl J Med 2013;369:

Efficacy Data in Atrial Fibrillation vs. Warfarin
ENGAGE AF-TIMI 48 Trial Edoxaban 60 mg N = 7012 Warfarin P-value Stroke or systemic embolic event 1.18% 1.5% <0.001 Efficacy Data in VTE vs. Warfarin Hokusai-VTE Trial N = 4118 N = 4122 1st recurrent VTE or VTE-related death 3.2% 3.5% N Engl J Med 2013;369: N Engl J Med 2013;369:

Edoxaban (Savaysa™) Dosing Atrial fibrillation
60 mg daily for CrCl ml/min 30 mg daily for CrCl ml/min DVT/PE treatment 60 mg daily 30 mg daily for CrCl ml/min or body weight ≤ 60 kg or on certain P-gp inhibitors Savaysa PI 2015.

Edoxaban (Savaysa™) Transitioning to edoxaban: From warfarin
Start when INR < 2.5 From any other oral anticoagulant or a LMWH Start at next scheduled dose From heparin Turn off heparin and start 4 hours later Savaysa PI 2015.

Edoxaban (Savaysa™) Transitioning from edoxaban: To warfarin
Start warfarin and taper edoxaban If on 60 mg decrease to 30 mg If on 30 mg decrease to 15 mg Draw INR immediately prior to edoxaban dose--when INR is > 2 stop edoxaban To any other oral agent, LMWH, or heparin Start alternative agent at time of next scheduled edoxaban dose Savaysa PI 2015.

Edoxaban (Savaysa™) Bottom line Additional review
Non-inferior to warfarin for stroke prevention in atrial fibrillation and for DVT/PE treatment Use of heparin/LWMH for 5-10 days prior to DVT/PE tx may limit use Watch renal function—high and low! No specific reversal agent….yet…. Additional review Mekaj YH et al. Ther Clin Risk Manag 2015;11:

Idarucizumab (Praxbind®)
Indication Reversal of dabigatran Emergency surgery/urgent procedures Life-threatening or uncontrolled bleeding Pharmacology Humanized monoclonal antibody specific for binding dabigatran Praxbind PI 2015.

Pharmacokinetics Onset is immediate Effect usually sustained for 24 hours Half-life 47 minutes (initial) 10.3 hours (terminal) Elimination Urine (32% in first 6 hours) Likely biodegradation Praxbind PI 2015.

Warnings and precautions Thromboembolic risk Re-elevation of coagulation parameters in hours Hypersensitivity reactions Sorbitol excipient Drug interactions None Praxbind PI 2015.

Interim report of RE-VERSE AD trial
Adverse Reactions: Interim report of RE-VERSE AD trial Event Idarucizumab N = 123 Hypokalemia 7% Delirium Constipation Pyrexia 6% Pneumonia Deaths 21% Thrombotic event 4% N Engl J Med 2015;373: Praxbind PI 2015.

Effect on Ecarin Clotting Time in Healthy Volunteers
seconds Praxbind PI 2015.

Dosing 5 grams Available in 2.5g/50ml vials Give as two consecutive doses Infuse both vials or give as 2 injections Must administer within 1 hour of removing from the vial May restart dabigatran in 24 hours if indicated Praxbind PI 2015.

Bottom line Effective reversal agent for dabigatran Usually will be a one time dose Will this increase the comfort level for providers using dabigatran? Anti-Xa reversal agent expected soon Additional review Mo Y, Yam F. Pharmacotherapy 2015;35:

Sacubitril/valsartan (Entresto™)
Indication NYHA Class II-IV to reduce risk of CV death and heart failure hospitalization Pharmacology Neprilysin inhibitor Blocks the break down of natriuretic peptides Entresto PI 2015

Pharmacokinetics Peaks in ~ 2 hours T ½ ~ 10 hours Valsartan has a higher bioavailability in Entresto vs. other formulations Sacubitril rapidly metabolized by esterases to active metabolite LBQ657 Majority excreted via kidneys Entresto PI 2015

Contraindications History of angioedema due to ACEI or ARB Concomitant use with an ACEI Avoid within 36 hours Concomitant use with aliskiren in diabetics Warnings and precautions Hyperkalemia Pregnancy Hypotension Entresto PI 2015

Common Adverse Reactions in PARADIGM Trial Sacubitril/valsartan
Enalapril N = 4212 P-value Symptomatic Hypotension 14% 9.2% <0.001 Potassium > 5.5 mmol/L 16.1% 17.3% 0.15 Cough 11.3% 14.3% < 0.001 Scr > 2.5 mg/dl 3.3% 4.5% 0.007 N Engl J Med 2014;37:

Key Outcomes from PARADIGM Trial
Sacubitril/Valsartan N = 4187 Enalapril N = 4212 HR (95% CI) NNT *Death from CV cause or First hospitalization for worsening HF 21.8% 26.5% 0.8 ( ) 21 Death from CV cause 13.3% 16.5% ( ) 32 First hospitalization for worsening HF 12.8% 15.6% 0.79 36 CV = cardiovascular HF = heart failure NNT = number need to treat * Primary outcome N Engl J Med 2014;37:

Dosing 49/51mg PO BID After 2-4 weeks increase to 97/103mg BID as tolerated May start at 24/26mg if: Not previously on an ACEI or ARB (or on very low doses) Severe renal impairment (< 30ml/min) Moderate hepatic impairment Entresto PI 2015

Availability Tablets 24-26 mg 49-51 mg mg Cost ~ $375 for #60 tabs Entresto PI 2015

Bottom line Impressive trial results Potential to become new standard for HF patients but some criticize trial design On-going trials will further define role Long-term safety? Do not use with an ACE inhibitor Additional review Singh JS, Land CC. Vasc Health Risk Manag. 2015;11:

Alirocumab (Praluent®)
Indication Adjunct to diet and max tolerated statin for adults with heterozygous familial hypercholesterolemia OR clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-C Pharmacology Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) inhibitor Praluent PI 2015

Pharmacokinetics Tmax 3-7 days Max PCSK9 inhibition in 4-9 hours LDL nadir in ~ 15 days No data in severe renal or hepatic impairment Praluent PI 2015

Contraindication/warnings/precautions Hypersensitivity reactions Some have required hospitalization Drug interactions None identified Praluent PI 2015

Adverse Reactions Reaction Alirocumab N = 2476 Placebo N = 1276
Injection site reactions 7.2% 5.1% Allergic reactions 8.6% 7.8% Anti-drug antibodies 4.8%* 0.6% * Patients had higher rate of injection site reactions (10.2% vs. 5.9%) Praluent PI 2015

Long Term Odyssey Study
P < 0.001 N Engl J Med 2015;372:

Dosing 75 mg SQ every 2 weeks If inadequate response after 4-8 weeks may increase to 150 mg SQ every 2 weeks Cost ~ $14,600 per year Praluent PI 2015

Administration Warm to room temp for min prior to administering Do not use if at room temp for ≥ 24h Inject SQ into thigh, abdomen or upper arm Prefilled pens or syringes Praluent PI 2015

Bottom line Highly effective at lowering LDL-C Expensive!!! Need to maximize statin therapy No data on CV morbidity & mortality Awaiting Odyssey Outcomes trial (late 2017?) Additional review Giugliano RP et al. J Am Coll Cardiol 2015;65:

Evolocumab (Repatha™)
Indication Adjunct to diet and max tolerated statin for adults with homozygous or heterozygous familial hypercholesterolemia OR clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-C Pharmacology PCSK9 inhibitor Repatha PI 2015

Evolocumab (Repatha™)
Dosing 140 mg SQ every 2 weeks 420 mg SQ once monthly Cost Estimated at ~ $14,100 per year Fourier Trial is evaluating mortality Expected results in 2018 Repatha PI 2015

Flibanserin (Addyi™) Indication Pharmacology
Hypoactive sexual desire disorder (HSDD) in premenopausal women Pharmacology Unknown mechanism for HSDD 5-HT1A agonist 5-HT2A, 5HT2B, 5-HT2C, D4 antagonist Addyi PI 2015

Flibanserin (Addyi™) Contraindications Warnings & precautions Alcohol
17-25% incidence of hypotension or syncope Moderate to strong CYP3A4 inhibitors Hepatic impairment (4 subjects) increased 4.5x in mild impairment T ½ extended from 10h to 26h Warnings & precautions Hypotension & syncope Somnolence & sedation Addyi PI 2015

Adverse Reactions from Placebo Controlled Trials
Filbanserin N = 1543 Placebo N = 1556 Dizziness 11.4% 2.2% Somnolence 11.2% 2.9% Nausea 10.4% 3.9% Fatigue 9.2% 5.5% Insomnia 4.9% 2.8% Dry mouth 2.4% 1% Addyi PI 2015

Flibanserin (Addyi™) Clinical efficacy
Three phase 3, 24-week trials; women Increased the number of “satisfying sexual events” per 28 days by over placebo In two studies the co-primary endpoint (sexual desire) was not significantly better than placebo Addyi PI 2015

Flibanserin (Addyi™) Dosing
100 mg at night May cause drowsiness Stop after 8 weeks if no improvement Prescribers and pharmacies must be certified through the Addyi REMS program Addyi PI 2015

Flibanserin (Addyi™) Bottom line Additional review
First drug approved for HSDD Controversial approval Watch for drug interactions and remind patients to avoid alcohol Additional review Gellad WF, et al. JAMA; published on- line July 6, 2015.

Insulin degludec (Tresiba™)
Indication Adults with diabetes mellitus Pharmacology “Ultra long-acting” Forms soluble, stable, multi-hexamers Insulin slowly, and continuously absorbed Tresiba PI 2015 Pharmacotherapy 2014;34:

Pharmacokinetics Average t ½ of 25 hours Steady-state within 3 days Glucose lowering effects for at least 42 hours Consistent absorption with minimal peak Within-person variability 4x lower vs. glargine Tresiba PI 2015 Clin Pharmacokinet 2014;53:

Proposed Clinical Advantages
More flexible dosing regimens Improved compliance Flatter glucose-lowering profile Less hypoglycemia Less nocturnal hypoglycemia Tighter glycemic control Pharmacotherapy 2014;34:

Dosing Once daily at any time At least 8 hours between doses Abdomen, upper arm or thigh Rotating sites Dose titrations every 3-4 days Dose conversion 1:1 conversion from other long-acting insulin Tresiba PI 2015

Dosing forms FlexTouch Pens (3 ml) U-100 (max of 80 units/dose) U-200 (max of 160 units/dose) Combined with insulin aspart (Ryzodeg®) 70/30 Availability? Tresiba PI 2015

Bottom line Long-acting insulin Once-daily, anytime dosing Will be available with aspart Additional review Drab S, Philis-Tsimikas A. Pharmacotherapy 2014;34:

Sugammadex (Bridion®)
Indication Reversal of rocuronium and vecuronium Pharmacology Gamma-cyclodextrin 8 sugar ring with negatively charged side chains Binds free rocuronium & vecuronium in plasma  remaining NMBA shifts from NMJ back to plasma Bridion PI 2015

Pharmacokinetics Onset in 2-3 minutes T ½ ~ 2 hours Excreted unchanged in the urine (95%) T ½ prolonged in renal impairment 19 hours in severe renal impairment Bridion PI 2015

Contraindications Hypersensitivity reactions (0.3% incidence) Reports of prolonged hospitalization and need for respiratory support Warnings/precautions Severe renal impairment (CrCl < 30 ml/min) No data for reversal in ICU Limited data in pediatrics No data in pregnancy or nursing mothers Bridion PI 2015 Core Evidence 2013;8:57-67.

Warnings/precautions Bradycardia  cardiac arrest within minutes of administration Treat with atropine Drug interactions Progestin-containing contraceptives Must use alternative contraception for 7 days Bridion PI 2015

Common Adverse Reactions
Sugammadex Placebo N = 544 2mg/kg N = 895 4mg/kg N = 1921 16mg/kg N = 98 Vomiting 11% 12% 15% 10% Pain 48% 52% 36% 38% Nausea 23% 26% Hypotension 4% 5% 13% Headache 7% 8% Bridion PI 2015

Minutes N = 48 N = 48 Bridion PI 2015

Dosing post surgery Train of four = 2 twitches 2 mg/kg IV bolus Post-tetanic count = 1-2 twitches and non TOF responses 4 mg/kg IV bolus Dosing 3 minutes post 1.2mg/kg of rocuronium 16 mg/kg bolus Bridion PI 2015

Mild to moderate impairment
Re-administration of rocuronium or vecuronium after sugammadex administration (up to 4 mg/kg) Renal function Wait Time Dose to Administer Normal 5 minutes to 4 hours 1.2 mg/kg rocuronium > 4 hours 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium Mild to moderate impairment < 24 hours > 24 hour* *preferred Bridion PI 2015

Cost 200mg ~ $90 500mg ~ $166 Availability 200mg and 500mg vials (100mg/ml)

Expense Comparison for a 70 kg Patient Neostigmine + Glycopyrrolate
Indication Sugammadex Neostigmine + Glycopyrrolate Succinylcholine Post surgery TOF = 2 $90 $84 NA Post surgery TOF = 0 $166 $115 Rapid Sequence Intubation $278 (includes rocuronium 100mg = $4.50) $21

Bottom line Fast, effective, safe reversal agent for rocuronium and vecuronium Will NOT reverse other NMB’s Watch for rare allergic reactions ? Potential to replace succinylcholine Additional review Schaller SJ, Fink H. Core Evidence 2013;8:57-67.

Naloxegol (Movantik™)
Indication Treatment of opioid-induced constipation in adults with chronic non- cancer pain Pharmacology Pegylated naloxone Minimal CNS penetration Displaces opioids from mu receptors in the GI tract Movantik PI 2015

Pharmacokinetics Peaks within 2 hours T ½ 6-11 hours CYP3A4 metabolism Renal excretion ~ 16% Contraindications GI obstruction Strong CYP3A4 inhibitors (i.e. ketoconazole or clarithromycin) Movantik PI 2015

Warnings and precautions GI perforation Opioid withdrawal No data in severe hepatic impairment Drug interactions Avoid moderate CYP3A4 inhibitors or reduce the dose (avoid grapefruit juice) Avoid strong inducers of CYP3A4 Movantik PI 2015

Common Adverse Reactions
Naloxegol 25 mg n = 446 Naloxegol 12.5 mg n = 441 Placebo n = 444 Abdominal pain 21% 12% 7% Diarrhea 9% 6% 5% Nausea 8% Flatulence 3% Movantik PI 2015

Efficacy for Opioid Induced Constipation
KODIAC-4 Trial Naloxegol 12.5 mg N = 213 Naloxegol 25 mg N = 214 Placebo *Response rate 40.8% 44.4% 29.4% p-value vs. placebo 0.02 0.001 -- KODIAC-5 Trial N = 232 35% 39.7% 29.3% 0.202 *at least 3 SBMs/wk, and increase of at least 1 SBM/wk in 9 of the 12 weeks & 3 out of the last 4 weeks N Engl J Med Jun 19;370(25):

Dosing Normal renal function 25 mg daily in the AM on an empty stomach CrCl < 60ml/min Start at 12.5 mg daily in the AM on an empty stomach Moderate CYP3A4 inhibitors 12.5 mg daily in the AM on an empty stomach Discontinue maintenance laxatives; may resume in 3 days Movantik PI 2015

Cost #30 = ~$300 Same price for 12.5 mg or 25 mg Advised not to split or crush Pharmacists Letter June 2015;31.

Bottom line Likely used when osmotic laxatives and stimulants not effective No direct comparison vs. other agents Stop laxatives when initiating therapy Additional review Poulsen JL, et al. Clin Exp Gastroenterol 2014;7:

Eluxadoline (Viberzi™)
Indication Treatment of irritable bowel syndrome with diarrhea (IBS-D) Pharmacology Mu-opioid receptor agonist Delta-opioid receptor antagonist Viberzi PI 2015

Cmax 2-4 hours T ½ 4-6 hours Metabolism Unclear; possible glucuronidation Elevated levels in hepatic impairment Minimal renal excretion Viberzi PI 2015

Contraindications Biliary obstruction, sphincter of Oddi dysfunction, EtOH use, pancreatitis, severe liver impairment, history of chronic or severe constipation, GI obstruction Warnings Risk of pancreatitis & sphincter of Oddi spasm Viberzi PI 2015

Drug interactions OATP1B1 Inhibitors Increase levels of eluxadoline Cyclosporine, gemfibrozil, antiretrovirals OATP1B1 & BCRP substrates Rosuvastatin levels may increase Drugs causing constipation Anticholinergics, opioids Viberzi PI 2015

Common Adverse Reaction in Placebo-Controlled Trials
Eluxadoline 100 mg BID N = 1032 Eluxadoline 75 mg BID N = 807 Placebo N = 975 Constipation 8% 7% 3% Nausea 5% Abdominal pain 6% 4% Vomiting 1% Viberzi PI 2015

Efficacy for IBS-D Study 1 Eluxadoline 75 mg BID N = 427 100 mg BID
Placebo *Response rate 24% 25% 17% p-value vs. placebo < 0.01 < 0.05 -- Study 2 N = 381 N = 382 29% 30% 16% < 0.001 *Simultaneous improvement in the daily worst abdominal pain score by ≥ 30% vs. baseline weekly average AND reduction in the Bristol Stool Scale to < 5 on at least 50% of the days within a 12-week time interval Viberzi PI 2015

Dosing 100 mg BID with food 75 mg BID if: No gallbladder Mild-moderate hepatic impairment Does not tolerate 100mg BID Taking a OATP1B1 inhibitor Discontinue if constipation develops and lasts for > 4 days Viberzi PI 2015

Bottom line Another option for IBS-D patients No active comparator trials Opioid-agonist; Schedule IV controlled substance Additional review Garnock-Jones. Drugs;75: Viberzi PI 2015

Elbasvir/Grazoprevir (Zepatier®)
Indication Genotype 1 or 4 Hepatitis C With or without Ribavirin Mechanism of action: Elbasvir HCV NS5A inhibitor Grazoprevir HCV NS3/4A protease inhibitor Zepatier [PI]

Population Genotype 1 Studies SVR12 Treatment Duration C-EDGE TN
Treatment Naïve +/- cirrhosis 95% (273/288) Zepatier 12 weeks C-EDGE CO-INFXN Treatment Naïve +/- cirrhosis + HIV-1 Co-infection 95% (179/189) C-SURFER Treatment Naïve / Treatment Experienced +/- cirrhosis + severe renal impairment 94% (115/122) C-EDGE TE Treatment Experienced +/- cirrhosis +/- HIV-1 co-infection 94% (90/96) 97% (93/96) Zepatier + RBV 16 weeks C-Salvage Treatment Experienced +/- cirrhosis 96% (76/79) Zepatier + RBV Zepatier [PI]

Genotype 4 Studies Population SVR12 Treatment Duration
C-EDGE TN Treatment Naïve +/- cirrhosis 97% (64/66) Zepatier 12 weeks C-EDGE CO-INFXN Treatment Naïve +/- cirrhosis +HIV-1 Co-infection C-SCAPE Treatment Naïve without cirrhosis C-EDGE TE Treatment Experienced +/- Cirrhosis 100% (8/8) Zepatier + RBV 16 weeks Zepatier [PI]

Elbasvir and Grazoprevir (Zepatier®)
Adverse effects Headache, nausea, fatigue Dosage and Administration One tablet once daily with or without food 50 mg elbasvir /100 mg grazeprevir No adjustments in renal dysfunction or dialysis Zepatier [PI]

Elbasvir and Grazoprevir (Zepatier®)
Bottom line One tablet, once daily treatment for HCV genotypes 1 or 4 infections Cure rates of >94% Duration of 12 weeks for most patient groups NS5A polymorphism testing recommended Approved in renal failure Additional review Bell, AM, et al. International Journal of Hepatology, 2016; Zepatier [PI]

Sofosbuvir and Velpatasvir (Epclusa®)
Indication Genotype 1, 2, 3, 4, 5, or HCV infection Without cirrhosis or with compensated cirrhosis With decompensated cirrhosis in combination with ribavirin Mechanism of Action Sofosbuvir: NS5B polymerase inhibitor Velpatasvir: NS5A inhibitor Epclusa [PI]

Response to 12 weeks of sofosbuvir-velpatasvir
ASTRAL-1 Trial Response to 12 weeks of sofosbuvir-velpatasvir Any genotype 99% (618/624) 1a 98% (206/210) 1b (117/118) 2 100% (104/104) 4 (116/116) 5 97% (34/35) 6 (41/41) Feld JJ, et al. N Engl J Med 2015;373:

ASTRAL-3 HCV Genotype 3 Foster GR, et al. N Engl J Med 2016;373:

Drug interactions P-gp inducers and CYP inducers decrease concentrations sofosbuvir and velpatasvir Amiodarone may lead to bradycardia when given with sofosbuvir Acid-reducing drugs decrease velpatasvir absorption Avoid proton pump inhibitors Epclusa [PI]

Dosing One tablet orally once daily 400 mg sofosbuvir /100 mg velpatasvir With or without food No dosage recommendations for patients with severe renal impairment (CrCl < 30 ml/min) Epclusa [PI]

Hepatitis C Dosage and Cost Summary
HCV Infection Treatment Duration Cost Genotypes 1,4,5,6 Harvoni® 12 weeksa $94,500 Genotype 1b Viekira Pak™ + ribavirin 12 weeksc $83,300 Genotype 2 Sofosbuvir + ribavirin 12 weeks ~ $84,000 Genotype 3 24 weeks ~ $168,000 Sofosbuvir + daclatasvir ~ $150,000 Genotype 4 Technivie™+ ribavirin ~ $77,000 Genotypes 1 & 4 Zepatier™ 12 weeksd ~ $54,000 Genotypes 1,2,3,4,5,6 Epclusa® 12 weekse ~$74,760 . a For genotype 1 patients receiving prior treatment and having cirrhosis 24 weeks is recommended b For genotype 1b without cirrhosis ribavirin not needed c For 1a with cirrhosis 24 weeks recommended d Patients with polymorphism or who are treatment experienced may require ribavirin and/or 16 weeks of treatment e Patients with decompensated cirrhosis require ribavirin. Sovaldi [PI] 2013. Viekira Pak [PI] Harvoni [PI] Daklinza [PI] 2015. Technivie [PI] 2015. Zepatier [PI] 2016. Epclusa [PI] 2016.

Two New Antibiotics Both approved for cIAIs & cUTIs
Used for gram-negative aerobes Ceftazidime-Avibactam (Avycaz™) Avibactam enhances in vitro activity in presence of some β-lactamases (KPCs) Ceftolozane/tazobactam (Zerbaxa™) Niche appears to be for multi-drug resistant Pseudomonas infections Avycaz PI 2015. Zerbaxa PI 2014 cIAI = complicated intrabdominal infections cUTIs = complicated urinary tract infections

New Drug Update 2016 Joe Strain, Pharm.D. SDSU College of Pharmacy

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