The Future of HIV Prevention and Treatment for Youth #Strive2optimize
Total Page：16
File Type：pdf, Size：1020Kb
THE AMERICAN ACADEMY OF HIV MEDICINE www.aahivm.org DECEMBER 2019 Patient Care, Practice Management & Professional Development Information for HIV Care Providers HIVSpecialist Integrating Transgender Healthcare for 24 The Future of Adolescents Not Your Parents’ HIV Prevention and Sex Talks 30 Treatment for Youth Adapting the Clinical Response 34 Fear of Addressing Substance Use and 36 Addiction DURABLE POWER AT PRESCRIBED REGIMEN FOR HIV-1 TREATMENT WEEK 144 Source: Ipsos Healthcare US HIV Therapy Monitor & Scope Study May-July 2019. BIKTARVY® (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg) combines the FTC/TAF* backbone with bictegravir, a novel and unboosted INSTI—for a powerful STR1,2 Learn more about the BIKTARVY 144 week data at BIKTARVY144.com Long-term e cacy in treatment-naïve adults at Week 1442-7 Results noninferior to comparators No treatment-emergent resistance associated with BIKTARVY through Week 1442-7 Study 1489: Virologic Response Study 1490: Virologic Response Week 48 Week 144 Week 48 Week 144 -0.6% (-4.8% to -2.6% (-8.5% to -3.5% (-7.9% to -1.9% (-7.8% to 1.0%; p=0.12)† 3.9%; p=0.52)† 100 3.6%; p=0.78)† 3.4%; p=0.39)† 100 HIV-1 RNA HIV-1 RNA <50 copies/mL <50 copies/mL % % % 92 93 % 93 80 % 80 89 % CASES 82% 84 82% 84 OF RESISTANCE WITH 60 60 BIKTARVY ve Adults, % Adults, ve ve Adults, % Adults, ve ï ï 0 40 40 In two large phase 3 clinical trials in treatment-naïve adults 20 20 • Among 634 treatment-naïve adults in Studies 1489 and 1490, 8 treatment-failure subjects were Treatment-Na Treatment-Na 0 0 tested and no amino acid substitutions emerged that were associated with BIKTARVY resistance Virologic failure Virologic failure HIV-1 RNA 1% 3% 1% 3% HIV-1 RNA 4% 1% 5% 3% ≥50 copies/mL ≥50 copies/mL BIKTARVY ABC/DTG/3TC BIKTARVY FTC/TAF+DTG urine glucose, and urine protein in all patients (n=314) (n=315) (n=320) (n=325) IMPORTANT SAFETY INFORMATION (cont’d) Contraindications as clinically appropriate. In patients with chronic †95% confi dence interval. †95% confi dence interval. Coadministration: Do not use BIKTARVY with dofetilide kidney disease, assess serum phosphorus. or rifampin. Lactic acidosis and severe hepatomegaly with Pivotal treatment-naïve study designs2-7: steatosis: Fatal cases have been reported with Warnings and precautions the use of nucleoside analogs, including FTC The e cacy and safety of BIKTARVY for treatment-naïve adults were evaluated in Studies 1489 and See Contraindications and Drug and TDF. Discontinue BIKTARVY if clinical or 1490. In Study 1489, a phase 3, randomized, double-blind, active-controlled study, treatment-naïve Drug interactions: Interactions sections. Consider the potential for drug laboratory fi ndings suggestive of lactic acidosis adults with an eGFR ≥50 mL/min were randomized in a 1:1 ratio to receive either BIKTARVY (n=314) interactions prior to and during BIKTARVY therapy and or pronounced hepatotoxicity develop, including or ABC/DTG/3TC (n=315) once daily. In Study 1490, a phase 3, randomized, double-blind, active- monitor for adverse reactions. hepatomegaly and steatosis in the absence of controlled study, treatment-naïve adults with an eGFR ≥30 mL/min were randomized in a 1:1 ratio to marked transaminase elevations. receive either BIKTARVY (n=320) or FTC/TAF+DTG (n=325) once daily. The primary endpoint for Immune reconstitution syndrome, including the both trials was the proportion of adults with HIV-1 RNA <50 copies/mL at Week 48. Secondary occurrence of autoimmune disorders with variable time endpoints included e cacy, safety, and tolerability through Week 96 and Week 144. to onset, has been reported. New onset or worsening renal impairment: Cases of Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through Week 144 were acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical diarrhea (6%), nausea (6%), and headache (5%).5 trials of BIKTARVY, there have been no cases of Fanconi INDICATION syndrome or proximal renal tubulopathy (PRT). Do not Please see Brief Summary of full Prescribing initiate BIKTARVY in patients with estimated creatinine Information for BIKTARVY, including BOXED BIKTARVY is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients clearance (CrCl) <30 mL/min. Patients with impaired WARNING, on the following pages. weighing ≥25 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in renal function and/or taking nephrotoxic agents those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no history of (including NSAIDs) are at increased risk of renal-related treatment failure and no known resistance to any component of BIKTARVY. adverse reactions. Discontinue BIKTARVY in patients IMPORTANT SAFETY INFORMATION who develop clinically signifi cant decreases in renal BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B function or evidence of Fanconi syndrome. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV Renal monitoring: Prior to or when initiating BIKTARVY and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and and during therapy, assess serum creatinine, CrCl, may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue *emtricitabine 200 mg/tenofovir alafenamide 25 mg. BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted. DURABLE POWER AT PRESCRIBED REGIMEN FOR HIV-1 TREATMENT WEEK 144 Source: Ipsos Healthcare US HIV Therapy Monitor & Scope Study May-July 2019. BIKTARVY® (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg) combines the FTC/TAF* backbone with bictegravir, a novel and unboosted INSTI—for a powerful STR1,2 Learn more about the BIKTARVY 144 week data at BIKTARVY144.com Long-term e cacy in treatment-naïve adults at Week 1442-7 Results noninferior to comparators No treatment-emergent resistance associated with BIKTARVY through Week 1442-7 Study 1489: Virologic Response Study 1490: Virologic Response Week 48 Week 144 Week 48 Week 144 -0.6% (-4.8% to -2.6% (-8.5% to -3.5% (-7.9% to -1.9% (-7.8% to 1.0%; p=0.12)† 3.9%; p=0.52)† 100 3.6%; p=0.78)† 3.4%; p=0.39)† 100 HIV-1 RNA HIV-1 RNA <50 copies/mL <50 copies/mL % % % 92 93 % 93 80 % 80 89 % CASES 82% 84 82% 84 OF RESISTANCE WITH 60 60 BIKTARVY ve Adults, % Adults, ve ve Adults, % Adults, ve ï ï 0 40 40 In two large phase 3 clinical trials in treatment-naïve adults 20 20 • Among 634 treatment-naïve adults in Studies 1489 and 1490, 8 treatment-failure subjects were Treatment-Na Treatment-Na 0 0 tested and no amino acid substitutions emerged that were associated with BIKTARVY resistance Virologic failure Virologic failure HIV-1 RNA 1% 3% 1% 3% HIV-1 RNA 4% 1% 5% 3% ≥50 copies/mL ≥50 copies/mL BIKTARVY ABC/DTG/3TC BIKTARVY FTC/TAF+DTG urine glucose, and urine protein in all patients (n=314) (n=315) (n=320) (n=325) IMPORTANT SAFETY INFORMATION (cont’d) Contraindications as clinically appropriate. In patients with chronic †95% confi dence interval. †95% confi dence interval. Coadministration: Do not use BIKTARVY with dofetilide kidney disease, assess serum phosphorus. or rifampin. Lactic acidosis and severe hepatomegaly with Pivotal treatment-naïve study designs2-7: steatosis: Fatal cases have been reported with Warnings and precautions the use of nucleoside analogs, including FTC The e cacy and safety of BIKTARVY for treatment-naïve adults were evaluated in Studies 1489 and See Contraindications and Drug and TDF. Discontinue BIKTARVY if clinical or 1490. In Study 1489, a phase 3, randomized, double-blind, active-controlled study, treatment-naïve Drug interactions: Interactions sections. Consider the potential for drug laboratory fi ndings suggestive of lactic acidosis adults with an eGFR ≥50 mL/min were randomized in a 1:1 ratio to receive either BIKTARVY (n=314) interactions prior to and during BIKTARVY therapy and or pronounced hepatotoxicity develop, including or ABC/DTG/3TC (n=315) once daily. In Study 1490, a phase 3, randomized, double-blind, active- monitor for adverse reactions. hepatomegaly and steatosis in the absence of controlled study, treatment-naïve adults with an eGFR ≥30 mL/min were randomized in a 1:1 ratio to marked transaminase elevations. receive either BIKTARVY (n=320) or FTC/TAF+DTG (n=325) once daily. The primary endpoint for Immune reconstitution syndrome, including the both trials was the proportion of adults with HIV-1 RNA <50 copies/mL at Week 48. Secondary occurrence of autoimmune disorders with variable time endpoints included e cacy, safety, and tolerability through Week 96 and Week 144. to onset, has been reported. New onset or worsening renal impairment: Cases of Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through Week 144 were acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical diarrhea (6%), nausea (6%), and headache (5%).5 trials of BIKTARVY, there have been no cases of Fanconi INDICATION syndrome or proximal renal tubulopathy (PRT). Do not Please see Brief Summary of full Prescribing initiate BIKTARVY in patients with estimated creatinine Information for BIKTARVY, including BOXED BIKTARVY is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients clearance (CrCl) <30 mL/min. Patients with impaired WARNING, on the following pages.