Emtricitabine/ Tenofovir Alafenamide for The

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Financial Disclosure USE OF BICTEGRAVIR/ ■ “I have had no financial relationship over the past 12 EMTRICITABINE/ months with any commercial sponsor with a vested TENOFOVIR interest in this presentation” ALAFENAMIDE FOR THE TREATMENT OF HIV By: Avery Aldridge, PharmD. VA Black Hills Health Care System 2/23/19

Pharmacist Learning Technician Learning Human Immunodeficiency Virus (HIV) Objectives Objectives ■ Enveloped single stranded RNA virus ■ Identify the mechanism of ■ Identify the active ingredients of ■ Chronic condition that weakens the immune system by action of each component of the antiretroviral combination destroying CD4+ T cells, which fight disease and infection the new HIV combination medication discussed in this medication bictegravir/ presentation ■ With appropriate antiretroviral therapy (ART), HIV can be emtricitabine/ tenofovir controlled alafenamide ■ Explain the correct dispensing – Only 55% of people in the United States with HIV have ■ Evaluate patient specific factors and storage requirements for suppressed viral loads to ensure safe use of the new the new HIV combination ■ As CD4+ T cells decline, a person is more susceptible to HIV combination medication medication bictegravir/ opportunistic infections bictegravir/ emtricitabine/ emtricitabine/ tenofovir tenofovir alafenamide alafenamide ■ May progress to acquired immunodeficiency syndrome (AIDS)

Guidelines for the Use of Antiretroviral Agents. Department of Health. 2018.

Epidemiology Pathophysiology

■ Contact with body fluids including: – Blood – Semen – Vaginal fluid – Rectal fluid – Breast milk ■ Transmission through: – Sexual contact – Sharing needles/ contact with an HIV infected needle – Pregnancy, childbirth, or breast feeding

AIDSinfo. U.S. Department of Health. 2019. AIDSinfo. U.S. Department of Health. 2019.

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Antiretroviral Therapy Antiretroviral Therapy

Pharmacologic Mechanism of Action Common Side Effects Examples Category Pharmacologic Mechanism of Action Common Side Effects Examples Category Entry Inhibitor Prevents binding and entry Hypersensitivity enfuviritide into the cell by binding to the reactions, injection site Non-Nucleoside Reverse Competitively inhibits the Rash, liver dysfunction, CNS etravirine transmembrane fusion protein reactions, increased Transcriptase Inhibitors HIV reverse transcriptase symptoms nevirapine gp41 incidence of bacterial (NNRTIs) enzyme efavirenz pneumonia Protease Inhibitors (PIs) Inhibit the viral protease Nausea, diarrhea, increased darunavir Entry Inhibitor Antagonist at chemokine Rash, hepatoxicity, upper maraviroc enzyme that is crucial to serum glucose and ritonavir receptor 5 (CCR5) coreceptor respiratory tract infection, maturation of immature HIV hypercholesterolemia, indinavir of the immune cell cough virions after they bud from lipodystrophy, increased Nucleoside Reverse Competitively inhibits the HIV Lactic acidosis, hepatic abacavir host cells bleeding Transcriptase Inhibitors reverse transcriptase enzyme steatosis, peripheral emtricitabine Integrase Inhibitors Prevent HIV DNA from being Hypersensitivity reactions dolutegravir (NRTIs) and terminates synthesis of neuropathy lamivudine (INSTIs) integrated into human DNA (rash), insomnia raltegravir DNA chains; must be tenofovir bictegravir phosphorylated to active metabolites Cachay ER. Merck Manual. 2019. Cachay ER. Merck Manual. 2019. Guidelines for the Use of Antiretroviral Agents. Department of Health. 2018. Guidelines for the Use of Antiretroviral Agents. Department of Health. 2018.

Goals of Therapy Antiretroviral Regimen for Treatment Naïve Patient ■ Two NRTIs and EITHER ■ Maximally and durably suppress HIV RNA viral load – An INSTI OR ■ Restore and preserve immunologic function – A NNRTI OR – A PI with a pharmacokinetic enhancer (booster) ■ Reduce HIV-associated morbidity and prolong the ■ For most patients an INSTI containing regimen is recommended duration/ quality of survival – Highly effective, infrequent adverse effects, few drug-drug interactions ■ Prevent HIV transmission ■ Recommended NRTI combination option: emtricitabine- tenofovir alafenamide – Fewer bone and kidney toxicities compared with tenofovir disoproxil fumarate

Guidelines for the Use of Antiretroviral Agents. Department of Health. 2018. Guidelines for the Use of Antiretroviral Agents. Department of Health. 2018.

bictegravir 50 mg/ emtricitabine 200 mg/ tenofovir alafenamide 25 mg (Biktarvy®) ■ Approved: February 2018 ■ Indications: – Complete regimen for the treatment of HIV-1 in adults with no antiretroviral treatment history – To replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen for at least 3 months, with no history of treatment failure, and no known substitutions associated with resistance to components of Biktarvy® ■ MOA: – Bictegravir= INSTI – Emtricitabine & tenofovir alafenamide= NRTIs ■ Administration: – Take 1 tablet by mouth once daily with or without food

Biktarvy. Gilead Sciences, Inc. 2018. Biktarvy LOGO. Gilead Sciences, Inc. 2018.

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Contraindications Renal Pharmacokinetics

■ Co-administration with dofetilide Impairment• Not recommended in patients Bictegravir Emtricitabine (FTC) Tenofovir and rifampin with severe renal impairment (BIC) Alafenamide (TAF) with CrCl <30 ml/min % bound to >99 <4 ~80 Precautions • No dose adjustment in patients plasma proteins with CrCl ≥ 30 ml/min Half life (hours) 17.3 10.4 0.51 ■ Immune reconstitution syndrome Hepatic Major route of Metabolism Glomerular filtration Metabolism ■ New onset or worsening renal elimination and active tubular impairment • No dose adjustment in patients with Impairment secretion ■ Lactic acidosis/ severe mild (Child-Pugh Class A) or moderate hepatomegaly with steatosis (Child-Pugh Class B) impairment % of dose 35 70 <1 • Has not been studied and is not excreted in urine ■ Severe acute exacerbation of hepatitis B in patients coinfected recommended in patients with severe % of dose 60.3 13.7 31.7 with HIV-1 and HBV impairment (Child-Pugh Class C) excreted in feces

Biktarvy. Gilead Sciences, Inc. 2018. Biktarvy. Gilead Sciences, Inc. 2018.

Pharmacokinetics Storage Lactation ■ Keep the container tightly closed • Breast feeding is not ■ Bictegravir inhibits cation transporter 2 (OCT2) and ■ Dispense only in original container recommended to avoid risking multidrug and toxin extrusion transporter 1 (MATE 1) in postnatal transmission of HIV-1 vitro infection – May increase concentrations of dofetilide Pregnancy Pregnancy exposure registry monitoring ■ Bictegravir is a substrate of CYP3A4 and UGT1A1 • outcomes Cost – Medications that inhibit CYP3A4 may increase plasma • Bictegravir and tenofovir alafenamide • $117.83 per tablet concentrations of bictegravir use during pregnancy has not been • 30-days supply: $3,534.90 – Medications that induce CYP3A4 may decrease plasma evaluated concentrations of bictegravir • Emtricitabine ■ Tenofovir alafenamide is a substrate of P-glycoprotein and • No difference in overall risk of major breast cancer resistance protein (BCRP) birth defects • Rate of miscarriage was not reported Biktarvy. Gilead Sciences, Inc. 2018. Biktarvy. Gilead Sciences, Inc. 2018. Lexi-Comp, Inc. bictegravir, emtricitabine, tenofovir alafenamide. 2019.

Coformulated bictegravir, emtricitabine, Objectives and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment ■ Primary Outcome: of HIV-1 infection (GS-US-380-1490): a – Proportion of participants who had plasma HIV-1 RNA of <50 copies/ml at week 48 randomized, double-blind, multicenter, phase 3, non-inferiority trial ■ Efficacy Endpoint: – CD4 count from baseline at week 48

Sax PE, et al. Lancet. 2017 Nov 4;390:2073-82.

Sax PE, et al. Lancet. 2017.

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Treatment Groups Design

■ Fixed-dose combination bictegravir 50 mg , emtricitabine 200 ■ Randomized 1:1, double-blind, multicenter, active- mg, and tenofovir alafenamide 25 mg + 2 placebos OR controlled, non-inferiority phase 3 trial ■ Dolutegravir 50 mg in combination with co-formulated emtricitabine 200 mg and tenofovir alafenamide 25 mg + ■ 126 outpatient centers in 10 countries placebo ■ Treated for 144 weeks ■ Randomization was stratified by: – HIV-1 RNA (≤100,000 copies/ml, >100,000 to ≤400,000 ■ Study visits at day 1, weeks 4, 8, 12 and then every 12 copies/ml, or >400,000 copies/ml) weeks through week 144 – CD4 count (<50 cells/μL, 50 to 199 cells/μL, or ≥200 ■ Laboratory analysis at each visit: HIV-1 RNA, CD4 count, cells/μL) complete or symptom directed physical examinations – Region (USA or outside USA)

Sax PE, et al. Lancet. 2017. Sax PE, et al. Lancet. 2017.

Inclusion Exclusion Baseline Demographics Bictegravir (n=320) Dolutegravir (n=325) ■ Opportunistic illness ■ Adults ≥ 18 years with Median age, years 33 (27-46) 34 (27-46) previously untreated HIV- indicating stage 3 HIV diagnosed within 30 days Sex, men 280 (88%) 288 (89%) 1 infection prior to screening Race, white 183 (57%) 195 (60%) ■ Decompensated cirrhosis ■ HIV-1 RNA levels ≥ 500 Region, USA 193 (60%) 193 (59%) copies/ml (ascites, variceal bleeding, encephalopathy) HIV-1 RNA ■ eGFR ≥ 30 ml/min ■ Current alcohol or concentration ■ Virological resistance substance use that may >100,000 to ≤400,000 54 (17%) 41 (13%) interfere with compliance testing showing sensitivity copies/ml to emtricitabine and ■ Females pregnant or >400,000 copies/ml 12 (4%) 13 (4%) breastfeeding tenofovir Median creatinine 120.4 120.6

Sax PE, et al. Lancet. 2017. clearance (ml/min) Sax PE, et al. Lancet. 2017.

Baseline Demographics Statistical Methods

Bictegravir (n=320) Dolutegravir (n=325) ■ Noninferiority assessed with 95% CI for the difference in virological response rates, with a non-inferiority margin of -12% CD4 count (cells/μL) – Mantel Haenszel proportion <50 15 (5%) 13 (4%) ■ Assuming a response rate of 91% at week 48 in both groups, a ≥50 to <200 29 (9%) 21 (6%) sample size of 600 patients would achieve a power of 95% to detect noninferiority at a one-sided alpha of 0.025 ≥200 to <350 67(21%) 77 (24%) ■ Primary endpoint analyzed by intention to treat (ITT) and per- ≥350 to <500 91 (28%) 94 (29%) protocol ≥500 118 (37%) 120 (37%) ■ Change in CD4 count from baseline at week 48 – Analysis of variance model (ANOVA)

Sax PE, et al. Lancet. 2017. Sax PE, et al. Lancet. 2017.

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Primary Outcome: HIV-1 RNA < 50 Efficacy Endpoint copies/ml

■ Bictegravir regimen was non-inferior to the dolutegravir regimen ■ Mean change in CD4 count at week 48 – 286 (89.4%) of 320 participants vs. 302 (92.9%) of 325 – 180 cells/μL for bictegravir group and 201 cells/μL for participants dolutegravir group – Difference -3.5%, 95% CI (-7.9 to 1.0) – P=0.10 – P= 0.12, for superiority ■ Per-protocol analysis ■ Viral resistance testing – 279 (99%) of 282 participants and 296 (99.7%) of 297 – 12 participants met criteria: 7 bictegravir, 5 participants dolutegravir – Difference -0.7%, 95% CI (-2.6 to 1.2) – P= 0.33, for superiority – No treatment emergent resistance identified

Sax PE, et al. Lancet. 2017. Sax PE, et al. Lancet. 2017.

Safety Safety Bictegravir (n=320) Dolutegravir (n=325) ■ Bictegravir group had a lower incidence of adverse effects Headache 40 (13%) 40 (12%) compared to dolutegravir group – 57 (18%) of 320 vs. 83 (26%) of 325, p=0.022 Diarrhea 37 (12%) 39 (12%) ■ Adverse events leading to discontinuation: – 5/320 (2%) of bictegravir group Nausea 25 (8%) 29 (9%) ■ Cardiac arrest, paranoia, chest pain, abdominal distention, sleep disorder, dyspepsia, tension headache, depressed mood and insomnia Nasopharyngitis 22 (7%) 31 (10%) – 1/325 (<1%) of dolutegravir group ■ Erythema and pruritis Fatigue 19 (6%) 26 (8%) ■ Deaths: Insomnia 16 (5%) 14 (4%) – Bictegravir group: 1 – Dolutegravir group: 2

Sax PE, et al. Lancet. Sax PE, et al. Lancet. 2017. 2017.

Strengths Limitations Author’s Conclusion Personal Conclusion ■ Bictegravir group showed ■ Possible new treatment ■ Appropriate comparator ■ Large number of non-inferior efficacy to the option for treatment naïve used participants had a CD4 dolutegravir group patients ■ ITT and per-protocol count ≥ 500 cells/μL and HIV-1 RNA < 100,000 at ■ No study participant ■ Convenient regimen that analysis provided the same discontinued treatment due promotes adherence conclusion baseline to lack of efficacy ■ Used FDA snapshot ■ Demographics: men, white, ■ Well tolerated ■ No drug resistance found algorithm to standardize USA, CrCl> 100ml/min ■ Need further studies to attain study ■ Gilead Sciences, Inc. ■ Discontinuations due to more data for those with HIV- ■ Randomized controlled funded the study adverse effects occurred 1 RNA >100,000 and CD4 trial rarely in both groups and count <500 cells/μL none occurred in more than ■ Double-blind prevents bias one participant Sax PE, et al. Lancet. 2017. Sax PE, et al. Lancet. 2017.

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Switching to fixed-dose bictegravir, Objectives emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed ■ Primary Outcome: – Proportion of participants with plasma HIV-1 adults in HIV-1: 48 week results of a RNA of ≥ 50 copies/ml at week 48 randomized, double-blind , multicenter, ■ Efficacy Endpoints: active-controlled, phase 3, non-interiority – Change in CD4 count from baseline to week 48 trial

Molina JM, et al. Lancet HIV. 2018 July;5(7):e357-65. Molina JM, et al. Lancet HIV. 2018.

Treatment Groups Design

■ Randomized 1:1, double-blind, multicenter, active-controlled, non- ■ Co-formulated bictegravir 50 mg, emtricitabine 200 inferiority, phase 3 trial mg, and tenofovir alafenamide 25 mg + placebo ■ 96 outpatient centers in 9 countries OR ■ Treated for 48 weeks then were able to participate in an open-label extension phase for an additional 96 weeks ■ Fixed-dose, combination dolutegravir 50 mg, ■ Study visits at baseline, week 4, 8, 12, 36, 48, and every 12 weeks abacavir 600 mg, and lamivudine 300 mg + thereafter if participating in open-label extension placebo ■ Laboratory analysis at each visit: CD4 counts, renal function, HIV-1 RNA

Molina JM, et al. Lancet HIV. 2018. Molina JM, et al. Lancet HIV. 2018.

Inclusion Exclusion Baseline Demographics

■ eGFR≥ 50 ml/min ■ Decompensated cirrhosis Bictegravir (n=282) Dolutegravir (n=281) (ascites, variceal bleeding, ■ No documented or suspected encephalopathy) Age (years) 47 (21-71) 45 (20-70) resistance to emtricitabine, tenofovir, dolutegravir, abacavir, ■ Current alcohol or substance use Sex, men 247 (88%) 252 (90%) or lamivudine that may interfere with compliance Race, white 206 (73%) 202 (73%) ■ HIV RNA <50 copies/ml at screening ■ Acute hepatitis in 30 days prior eGFR (ml/min) 101 101 to study entry ■ Currently on a stable regimen CD4 count (cells/μL) for ≥3 months before screening ■ Chronic hepatitis B infection with HIV-1 RNA ≤50 copies/ml ≥500 227 (80%) 205 (73%) ■ Females breastfeeding or for ≥3 months before screening pregnant Time on regimen before 1.1 1.2 ■ Currently receiving dolutegravir, study drug dosing (years) abacavir, and lamivudine

Molina JM, et al. Lancet HIV. 2018. Molina JM, et al. Lancet HIV. 2018.

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Statistical Methods Primary Outcome: HIV-1 RNA ≥ 50 copies/ml ■ Non-inferiority established if the upper bound of 95% CI for the difference between the groups is <4% ■ Bictegravir regimen was non-inferior to the dolutegravir regimen – Using an unconditional exact method with two inverted one- sided tests – 3 (1%) of 282 participants vs. 1 (<1%) of 281 participants ■ Assuming that 2% of participants in each group would have HIV- – Difference 0.7%, 95% CI (-1.0 to 2.8) RNA of ≥ 50 copies/ml at week 48, a sample size of 520 – P=0.62, for superiority participants would achieve 90% power to detect non-inferiority at a one-sided alpha of 0.025 ■ Per-protocol analysis ■ Primary endpoint analyzed by intention to treat (ITT) and per- – 1 (<1%) of 257 participants vs. 0 (0%) of 256 participants protocol – Difference 0.4%, 95% CI (-1.1 to 2.2) ■ Change in CD4 count from baseline at week 48 – P=1.00, for superiority – Analysis of variance model (ANOVA)

Molina JM, et al. Lancet HIV. 2018. Molina JM, et al. Lancet HIV. 2018.

Efficacy Endpoint Safety

Bictegravir Dolutegravir p value ■ Mean change in CD4 count from baseline to week 48 (n=282) (n=281) – Decreased by 31 cells/μL in bictegravir group and increased Headache 7 (2%) 8 (3%) 0.80 by 4 cells/μL in the dolutegravir group – Difference -35 cells/μL, 95% CI (-67 to -3), p=0.031 Diarrhea 2 (1%) 4 (1%) 0.45

■ After adjusting for baseline CD4 count, changes were not Abnormal 1 (<1%) 5 (2%) 0.12 significant dreams – Difference -21 cells/μL, 95%CI (-51 to 9), p=0.18 Fatigue 1 (<1%) 3 (1%) 0.37 ■ Viral resistance testing – 5 participants met criteria: 3 bictegravir, 2 dolutegravir Treatment 23 (8%) 44 (16%) 0.006 – No virological resistance developed related adverse event Molina JM, et al. Lancet HIV. 2018. Molina JM, et al. Lancet HIV. 2018.

Safety Strengths Limitations ■ Met power for primary ■ Demographics: men, white, ■ Adverse events leading to discontinuation, p= 0.29 outcome of the study CD4 count – 6/282 (2%) of bictegravir group ■ ITT and per-protocol ■ Study population reasonably ■ Headache, abnormal dreams, cerebrovascular accident, suicidal ideation, vomiting analysis provided the same healthy conclusion – 2/281 (1%) of dolutegravir group ■ Gilread Sciences, Inc. funded ■ Headache, pruritis ■ Used FDA snapshot the study algorithm to standardize ■ Could not assess acceptability ■ Deaths, p= 0.50 study – Bictegravir: 2 or palatability of decreased ■ Randomized controlled tablet size with bictegravir – Dolutegravir: 0 trial regimen due to double-blind, ■ Double-blind prevents bias active-controlled study

Molina JM, et al. Lancet HIV. 2018. Molina JM, et al. Lancet HIV. 2018.

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Author’s Conclusion Personal In Conclusion Conclusions ■ Switching to bictegravir, ■ Bictegravir group reliably ■ bictegravir 50 mg/ emtricitabine 200 mg/ tenofovir emtricitabine, and continued to suppress HIV-1 alafenamide 25 mg (Biktarvy®) has shown effectiveness and tenofovir alafenamide RNA when switch from a stable regimen non-inferiority to several established HIV-1 regimens when maintained high efficacy treating HIV-1 naïve patients and switching from a stable HIV rates and was non-inferior ■ Bictegravir continued to to remaining on sustain immunologic function regimen dolutegravir, abacavir, and ■ Patient’s has less treatment ■ Well tolerated overall lamivudine related adverse events with ■ Provides an option for switching therapy to a preferred regimen ■ No emergence of drug bictegravir group resistance ■ No trials available that evaluate use in a patient that is not well ■ Well tolerated regimen controlled on a HIV regimen or has encountered previous resistance

Molina JM, et al. Lancet HIV. 2018. Molina JM, et al. Lancet HIV. 2018. Sax PE, et al. Lancet. 2017.

References Pharmacist Post-test Question

■ Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Department of Health and Human Services. [updated 2018 Oct 25; cited 2019 Feb 2]. Available at http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. ■ AIDSinfo. U.S. Department of Health and Human Services. [updated 2019 Feb 2; cited 2019 Feb 2]. Available from: Which of the following components is correctly matched with its https://aidsinfo.nih.gov/. mechanism of action? ■ Cachay ER. Merck Manual Professional Version: Drug Treatment of HIV Infection [Internet]. Merck Sharp & Dohme Corp.; 2019 [cited 2019 Feb 9]. Available from: https://www.merckmanuals.com/professional/infectious-diseases/human- immunodeficiency-virus-hiv/drug-treatment-of-hiv-infection a. bictegravir (Integrase Strand Transfer Inhibitor- INSTI) ■ Biktarvy LOGO. Gilead Sciences, Inc. 2018. Available from: www.biktarvyhcp.com b. emtricitabine (Non-Nucleoside Reverse Transcriptase Inhibitor- ■ Biktarvy (bictegravir/ emtricitabine/ tenofovir alafenamide) [package insert]. Foster City, CA: Gilead Sciences, Inc., 2018 Feb. NNRTI) ■ Lexi-Comp, Inc. (bictegravir, emtricitabine, tenofovir alafenamide). Lexi-Comp, Inc.; 11 Feb 2019.

■ Sax PE, Pozniak A, Montes ML, Koenig E, DeJesus E, Stellbrink HJ, et al. Coformulated bictegravir, emtricitabine, and tenofovir c. tenofovir alafenamide (Protease Inhibitor- PI) alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US- 380-1490): a randomized, double-blind, multicenter, phase 3, non-inferiority trial. Lancet. 2017 Nov 4;390:2073-82. d. tenofovir alafenamide (Integrase Strand Transfer Inhibitor – INSTI) ■ Molina JM, Ward D, Brar I, Mills A, Stellbrink HJ, Lopez-Cortes L, et al. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults in HIV-1: 48 week results of a randomized, double-blind , multicenter, active-controlled, phase 3, non-interiority trial. Lancet HIV. 2018 July;5(7):e357-65.

Pharmacist Post-test Question Pharmacist Post-test Question

Which of the following components is correctly matched with its Which of the following patients should NOT initiate therapy with the new HIV mechanism of action? combination medication bictegravir/ emtricitabine/ tenofovir alafenamide? a. bictegravir (Integrase Strand Transfer Inhibitor- INSTI) a. A 39 year-old female who has no history of resistance with any component of Biktarvy® b. emtricitabine (Non-Nucleoside Reverse Transcriptase Inhibitor- NNRTI) b. A 67 year-old male who received confirmation of a negative hepatitis B blood test c. tenofovir alafenamide (Protease Inhibitor- PI) c. A 55 year-old man with liver impairment (Child-Pugh Class A) d. tenofovir alafenamide (Integrase Strand Transfer Inhibitor – INSTI) d. A 25 year-old woman with a CrCl of 28 ml/min who uses 2 forms of contraceptive

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Pharmacist Post-test Question Technician Post-test Question

Which of the following patients should NOT initiate therapy with the new HIV Name the active ingredients and trade name of the new combination combination medication bictegravir/ emtricitabine/ tenofovir alafenamide? medication discussed in this presentation a. A 39 year-old female who has no history of resistance with any component a. dolutegravir, emtricitabine, tenofovir alafenamide of Biktarvy® b. bictegravir, emtricitabine, tenofovir disoproxil fumarate b. A 67 year-old male who received confirmation of a negative hepatitis B blood test c. dolutegravir, emtricitabine, tenofovir disoproxil fumarate c. A 55 year-old man with liver impairment (Child-Pugh Class A) d. bictegravir, emtricitabine, tenofovir alafenamide d. A 25 year-old woman with a CrCl of 28 ml/min who uses 2 forms of contraceptive

Technician Post-test Question Technician Post-test Question

Name the active ingredients and trade name of the new combination How is this combination product dispensed? medication discussed in this presentation a. In blister packs a. dolutegravir, emtricitabine, tenofovir alafenamide b. In its original container b. bictegravir, emtricitabine, tenofovir disoproxil fumarate c. Repackaged in a new bottle c. dolutegravir, emtricitabine, tenofovir disoproxil fumarate d. In a medication box organization system d. bictegravir, emtricitabine, tenofovir alafenamide

Technician Post-test Question

How is this combination product dispensed? a. In blister packs b. In its original container c. Repackaged in a new bottle d. In a medication box organization system

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