Daclatasvir: Drug information
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(For additional information see "Daclatasvir: Patient drug information")

For abbreviations and symbols that may be used in Lexicomp (show table)
ALERT: US Boxed Warning
Hepatitis B virus reactivation:

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with daclatasvir. HBV reactivation has been reported in hepatitis C virus (HCV)/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate management for HBV infection as clinically indicated.

Brand Names: US
  • Daklinza
Brand Names: Canada
  • Daklinza
Pharmacologic Category
  • Antihepaciviral, NS5A Inhibitor;
  • NS5A Inhibitor
Dosing: Adult

Chronic hepatitis C (genotype 1 or 3): Oral: Note: Discontinue daclatasvir if other antihepaciviral therapy is permanently discontinued. Not indicated as monotherapy.

Genotype 1:

Without cirrhosis or with compensated (Child-Pugh class A) cirrhosis: 60 mg once daily with concomitant sofosbuvir for 12 weeks. Note: AASLD/IDSA 2015 guidelines recommend 24 weeks of therapy with concomitant sofosbuvir (with or without ribavirin) in patients with compensated cirrhosis and genotype 1; consult clinical guidelines for additional details (AASLD/IDSA 2015).

With decompensated (Child-Pugh class B or C) cirrhosis or post liver transplant: 60 mg once daily with concomitant sofosbuvir and ribavirin for 12 weeks

When used concomitantly with asunaprevir [Canadian product] for patients with genotype 1b (with or without compensated cirrhosis), the recommended duration of therapy is 24 weeks; when used concomitantly with asunaprevir, peginterferon alfa, and ribavirin in patients with genotypes 1 (with or without compensated cirrhosis), the recommended duration of therapy is 24 weeks. (Sunvepra Canadian labeling 2017). Note: Discontinuation of therapy is recommended for virologic breakthrough (>1 log10 IU/mL increase in HCV RNA from nadir).

Genotype 3:

Without cirrhosis: 60 mg once daily with concomitant sofosbuvir for 12 weeks

With compensated (Child-Pugh class A) or decompensated (Child-Pugh class B or C) cirrhosis or post liver transplant: 60 mg once daily with concomitant sofosbuvir and ribavirin for 12 weeks. Note: AASLD/IDSA 2015 guidelines recommend 24 weeks of therapy with concomitant sofosbuvir (with or without ribavirin in treatment-naive patients and with ribavirin in treatment-experienced patients) with compensated cirrhosis and genotype 3; consult clinical guidelines for additional details (AASLD/IDSA 2015).

Chronic hepatitis C (genotype 2):

Off-label use (AASLD/IDSA 2015): Oral:

Treatment-naive patients: 60 mg once daily with concomitant sofosbuvir for 12 weeks (only for patients unable to tolerate ribavirin)

Treatment-experienced patients in whom a previous regimen of sofosbuvir and ribavirin has failed: 60 mg once daily with concomitant sofosbuvir for 24 weeks with or without ribavirin (interferon-ineligible patients)

Dosage adjustment with concomitant medications:

Strong inhibitors of CYP3A and certain HIV antiviral agents: 30 mg once daily

Moderate CYP3A inducers or nevirapine: 90 mg once daily

Strong CYP3A inducers: Concomitant use is contraindicated.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment necessary.

Dosing: Hepatic Impairment

Child-Pugh class A, B, or C: No dosage adjustment necessary.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Daklinza: 30 mg, 60 mg, 90 mg [contains fd&c blue #2 aluminum lake]

Generic Equivalent Available (US)

No

Administration

Oral: Administer with or without food.

Use

Chronic hepatitis C: Treatment of chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection in combination with sofosbuvir, with or without ribavirin

Limitations of use: Sustained virologic response rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving daclatasvir in combination with sofosbuvir for 12 weeks.

Use: Off-Label

Chronic hepatitis C (genotype 2)

Adverse Reactions

All adverse drug reactions are from combination therapy trials with sofosbuvir.

>10%:

Central nervous system: Fatigue (14% to 15%), headache (12% to 14%)

Gastrointestinal: Nausea (8% to 15%)

Hematologic & Oncologic: Anemia (20%)

1% to 10%:

Central nervous system: Drowsiness (5%), insomnia (3%)

Dermatologic: Skin rash (8%)

Gastrointestinal: Diarrhea (3% to 5%), increased serum lipase (>3x ULN, transient)

<1%, postmarketing, and/or case reports: Reactivation of HBV (FDA Safety Alert Dec. 8, 2016)

Contraindications

Concurrent use of strong CYP3A inducers (eg, carbamazepine, phenytoin, rifampin, St John's wort). When used in combination with other agents (eg, ribavirin), the contraindications to those agents also apply (refer to respective labeling information).

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to daclatasvir or any component of the formulation; concurrent use with strong inducers of CYP3A4 and P-glycoprotein (P-gp)

Warnings/Precautions

Concerns related to adverse effects:

• Bradycardia: When used in combination with sofosbuvir and amiodarone, symptomatic bradycardia (eg, near-fainting, dizziness, lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pain, confusion, memory problems) has been reported; pacemaker intervention may be required. Bradycardia generally occurs within hours or days but has been observed up to 2 weeks after treatment initiation. Risk factors include concomitant beta blocker use, underlying cardiac morbidities, and/or advanced hepatic disease. Patients receiving amiodarone (with no alternate treatment options) and initiating daclatasvir and sofosbuvir treatment, and patients on daclatasvir and sofosbuvir treatment who are initiating amiodarone therapy should have inpatient cardiac monitoring for the first 48 hours of amiodarone coadministration and daily outpatient self-monitoring through at least the first 2 weeks of treatment. Patients discontinuing amiodarone just prior to starting daclatasvir and sofosbuvir treatment should also undergo similar cardiac monitoring procedures. Bradycardia usually resolves after HCV treatment discontinuation.

Disease-related concerns:

• Cardiovascular disease: Patients with underlying cardiac morbidities and also taking concomitant amiodarone are at increased risk for symptomatic bradycardia; use with caution and monitor for bradycardia.

• Hepatic disease: Patients with advanced hepatic disease and also taking concomitant amiodarone are at increased risk for symptomatic bradycardia; use with caution. Sustained virologic response rates are reduced in HCV genotype 3-infected patients with cirrhosis. Optimal duration of treatment for HCV genotype 3-infected patients with cirrhosis or HCV genotype 1 patients with Child-Pugh class C cirrhosis has not been established.

• Hepatitis B virus reactivation: [US Boxed Warning]: Hepatitis B virus (HBV) reactivation has been reported in hepatitis C virus (HCV)/HBV coinfected patients who were receiving or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy; some cases have resulted in fulminant hepatitis, hepatic failure, and death. Test all patients for evidence of current or prior HBV infection prior to initiation of daclatasvir; monitor HCV/HBV co-infected patients for hepatitis flare or HBV reactivation during treatment and post-treatment follow-up. Initiate treatment for HBV infection as clinically indicated. HBV reactivation has been reported in HBsAg positive patients and in patients with serologic evidence of resolved HBV infection (ie, HBsAg negative and anti-HBc positive) and is characterized by an abrupt increase in HBV replication manifested as a rapid increase in serum HBV DNA level; reappearance of HBsAg may occur in patients with resolved HBV infection. Risk of HBV reactivation may be increased in patients receiving certain immunosuppressants or chemotherapeutic agents.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Appropriate use: Do not use as monotherapy; use only in combination with other antihepatitis C virus drugs.

Metabolism/Transport Effects

Substrate of CYP3A4 (major), P-glycoprotein/ABCB1; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits BCRP/ABCG2, OATP1B1/SLCO1B1, OATP1B3/SLCO1B3, P-glycoprotein/ABCB1

Drug Interactions

(For additional information: Launch drug interactions program)

Afatinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Afatinib. Management: Per US labeling: reduce afatinib by 10mg if not tolerated. Per Canadian labeling: avoid combination if possible; if used, administer the P-gp inhibitor simultaneously with or after the dose of afatinib. Risk D: Consider therapy modification

Amiodarone: Daclatasvir may enhance the bradycardic effect of Amiodarone. Risk X: Avoid combination

Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Asunaprevir: OATP1B1/SLCO1B1 Inhibitors may increase the serum concentration of Asunaprevir. Risk X: Avoid combination

Betrixaban: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Betrixaban. Management: Decrease the betrixaban dose to an initial single dose of 80 mg followed by 40 mg once daily if combined with a P-glycoprotein inhibitor. Risk D: Consider therapy modification

Bilastine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Bilastine. Management: Consider alternatives when possible; bilastine should be avoided in patients with moderate to severe renal insufficiency who are receiving p-glycoprotein inhibitors. Risk D: Consider therapy modification

Brentuximab Vedotin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Brentuximab Vedotin. Specifically, concentrations of the active monomethyl auristatin E (MMAE) component may be increased. Risk C: Monitor therapy

Buprenorphine: Daclatasvir may increase the serum concentration of Buprenorphine. Risk C: Monitor therapy

Celiprolol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Celiprolol. Risk C: Monitor therapy

Ceritinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of ceritinib with a narrow therapeutic index CYP3A substrate (eg, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus) should be avoided when possible. Risk C: Monitor therapy

Colchicine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Colchicine. Colchicine distribution into certain tissues (e.g., brain) may also be increased. Management: Colchicine is contraindicated in patients with impaired renal or hepatic function who are also receiving a p-glycoprotein inhibitor. In those with normal renal and hepatic function, reduce colchicine dose as directed. Risk D: Consider therapy modification

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of Daclatasvir. Management: Increase the daclatasvir dose to 90 mg once daily if used with a moderate CYP3A4 inducer. Risk D: Consider therapy modification

CYP3A4 Inducers (Strong): May decrease the serum concentration of Daclatasvir. Risk X: Avoid combination

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Daclatasvir. Management: Decrease the daclatasvir dose to 30 mg once daily if combined with a strong CYP3A4 inhibitor. No dose adjustment is needed when daclatasvir is used with darunavir/cobicistat. Risk D: Consider therapy modification

Dabigatran Etexilate: P-glycoprotein/ABCB1 Inhibitors may increase serum concentrations of the active metabolite(s) of Dabigatran Etexilate. Management: Dabigatran dose reductions may be needed. Specific recommendations vary considerably according to US vs Canadian labeling, specific P-gp inhibitor, renal function, and indication for dabigatran treatment. Refer to full monograph or dabigatran labeling. Risk D: Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Dasatinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Dexamethasone (Systemic): May decrease the serum concentration of Daclatasvir. Management: US labeling recommends increasing the daclatasvir dose to 90 mg once daily if used with dexamethasone. Canadian labeling states that the combination of daclatasvir and dexamethasone is contraindicated. Risk D: Consider therapy modification

Digoxin: Daclatasvir may increase the serum concentration of Digoxin. Management: See full interaction monograph for details. Risk D: Consider therapy modification

DOXOrubicin (Conventional): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of DOXOrubicin (Conventional). Management: Seek alternatives to P-glycoprotein inhibitors in patients treated with doxorubicin whenever possible. One U.S. manufacturer (Pfizer Inc.) recommends that these combinations be avoided. Risk D: Consider therapy modification

Edoxaban: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Edoxaban. Management: See full monograph for details. Reduced doses are recommended for patients receiving edoxaban for venous thromboembolism in combination with certain inhibitors. Similar dose adjustment is not recommended for edoxaban use in atrial fibrillation. Risk D: Consider therapy modification

Everolimus: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Everolimus. Management: Everolimus dose reductions are required for patients being treated for subependymal giant cell astrocytoma or renal cell carcinoma. See prescribing information for specific dose adjustment and monitoring recommendations. Risk D: Consider therapy modification

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Grazoprevir: OATP1B1/SLCO1B1 Inhibitors may increase the serum concentration of Grazoprevir. Risk X: Avoid combination

HMG-CoA Reductase Inhibitors (Statins): Daclatasvir may increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Risk D: Consider therapy modification

Naldemedine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Naldemedine. Risk C: Monitor therapy

Naloxegol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Naloxegol. Risk C: Monitor therapy

Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Nevirapine: May decrease the serum concentration of Daclatasvir. Management: Increase the daclatasvir dose to 90 mg once daily. Risk D: Consider therapy modification

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

PAZOPanib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of PAZOPanib. Risk X: Avoid combination

PAZOPanib: BCRP/ABCG2 Inhibitors may increase the serum concentration of PAZOPanib. Risk X: Avoid combination

P-glycoprotein/ABCB1 Substrates: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Risk D: Consider therapy modification

Prucalopride: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Prucalopride. Risk C: Monitor therapy

Ranolazine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Ranolazine. Risk C: Monitor therapy

Rifapentine: May decrease the serum concentration of Daclatasvir. Management: US labeling recommends increasing the daclatasvir dose to 90 mg once daily if used with rifapentine. Canadian labeling states that the combination of daclatasvir and rifapentine is contraindicated. Risk D: Consider therapy modification

RifAXIMin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of RifAXIMin. Risk C: Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Silodosin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Silodosin. Risk X: Avoid combination

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

St John's Wort: May decrease the serum concentration of Daclatasvir. Risk X: Avoid combination

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Risk D: Consider therapy modification

Tacrolimus (Systemic): Daclatasvir may decrease the serum concentration of Tacrolimus (Systemic). Specifically, this decrease in tacrolimus concentrations may occur with continued prolonged combination therapy. Daclatasvir may increase the serum concentration of Tacrolimus (Systemic). Specifically, this increase in tacrolimus concentrations may occur during the first week of combined therapy. Risk C: Monitor therapy

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Topotecan: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Topotecan. Risk X: Avoid combination

Venetoclax: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Venetoclax. Management: Reduce the venetoclax dose by at least 50% in patients requiring these combinations. Risk D: Consider therapy modification

VinCRIStine (Liposomal): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of VinCRIStine (Liposomal). Risk X: Avoid combination

Voxilaprevir: OATP1B1/SLCO1B1 Inhibitors may increase the serum concentration of Voxilaprevir. Risk X: Avoid combination

Warfarin: Daclatasvir may enhance the anticoagulant effect of Warfarin. Risk C: Monitor therapy

Pregnancy Implications

If used in combination with ribavirin, all warnings related to the use of ribavirin and pregnancy and/or contraception should be followed. Mother-to-child transmission of HCV does not occur if the woman is not viremic, therefore, HCV-infected women of childbearing potential should postpone pregnancy until therapy is complete. Treatment of HCV is not recommended for women who are already pregnant (AASLD/IDSA 2015).

Breast-Feeding Considerations

It is not known if daclatasvir is excreted into breast milk. According to the manufacturer, the decision to breastfeed during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother. Breast-feeding is not linked to the spread of hepatitis C virus; however, if nipples are cracked or bleeding, breast-feeding is not recommended (CDC [Workowski 2015]).

Monitoring Parameters

Manufacturer’s labeling: Hepatic function at baseline and periodically when clinically indicated during treatment. Prior to treatment initiation in genotype 1a patients with cirrhosis, consider screening for the presence of NS5A polymorphisms at amino acid positions M28, Q30, L31, and Y93 in patients with cirrhosis. Hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) prior to initiation; in patients with serologic evidence of hepatitis B virus (HBV) infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during treatment and during post-treatment follow-up. If used in combination with amiodarone or in patients who discontinued amiodarone just prior to initiating sofosbuvir in combination with daclatasvir, inpatient cardiac monitoring for the first 48 hours of coadministration, then outpatient self-monitoring of heart rate daily through at least the first 2 weeks of treatment.

Alternate recommendations (AASLD/IDSA 2015):

Baseline (within 12 weeks prior to starting antiviral therapy): CBC, INR, hepatic function panel (albumin, total and direct bilirubin, ALT, AST, and alkaline phosphatase), calculated GFR

Baseline (at any time prior to starting antiviral therapy): HCV genotype and subtype, quantitative HCV viral load

During therapy: CBC, serum creatinine, calculated GFR, hepatic function panel (after 4 weeks of therapy and as clinically indicated); quantitative HCV viral load testing (after 4 weeks of therapy and at 12 weeks after completion of therapy). If quantitative HCV viral load is detectable at treatment week 4, repeat testing is recommended after 2 additional weeks of treatment (treatment week 6).

Mechanism of Action

Daclatasvir binds to the N-terminus within Domain 1 of HCV nonstructural protein 5A (NS5A) and inhibits viral RNA replication and virion assembly.

Pharmacodynamics/Kinetics

Distribution: Vdss: 47 L

Protein binding: ~99%

Metabolism: Primarily via CYP3A4

Bioavailability: 67%

Half-life elimination: ~12 to 15 hours

Time to peak, plasma: ≤2 hours

Excretion: Feces (88%, 53% unchanged); urine (6.6%, primarily unchanged)

Pricing: US

Tablets (Daklinza Oral)

30 mg (28): $25,200.00

60 mg (28): $25,200.00

90 mg (28): $25,200.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Daclacef (BD);
  • Daclavir (BD);
  • Daklinza (AR, AT, AU, BB, BE, BR, CH, CZ, DE, DK, EE, ES, FI, FR, GB, HK, HR, HU, IE, IL, IS, JP, KR, LT, LU, MT, NL, NO, PL, PT, QA, RO, SA, SE, SG, SK, TH);
  • Virodacla (BD)
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REFERENCES

  1. AASLD/IDSA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org/full-report-view. Updated 2015. Accessed September 16, 2015.
  2. Daklinza (daclatasvir) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Co; November 2017.
  3. Daklinza (daclatasvir) [product monograph]. Montreal, Canada: Bristol-Myers Squibb Canada; November 2016.
  4. FDA Safety Alert. MedWatch. Direct-Acting Antiviral for Hepatitis C: Drug Safety Communication-Risk of Hepatitis B reactivating. Food and Drug Administration website. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm523690.htm. Accessed December 8, 2016.
  5. Nelson DR, Cooper JN, Lalezari JP, et al; ALLY-3 Study Tea. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015;61(4):1127-1135. [PubMed 25614962]
  6. Sunvepra (asunaprevir) [product monograph]. Montreal, Canada: Bristol-Myers Squibb Canada; January 2017.
  7. Workowski KA, Bolan GA; Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015;64(RR-03):1-137. [PubMed 26042815]
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