TY - JOUR
T1 - Effectiveness and Safety of Bictegravir/Emtricitabine/ Tenofovir Alafenamide in Patients with HIV-1 Infection and Ongoing Substance Use Disorder
T2 - The BASE Study
AU - Havens, Joshua P.
AU - Bares, Sara H.
AU - Lyden, Elizabeth
AU - Podany, Anthony T.
AU - Scarsi, Kimberly K.
AU - Fadul, Nada
AU - Swindells, Susan
N1 - Funding Information:
The BASE study team thanks the participants and Jennifer O’Neill, Maureen Kubat, and Valentina Orduna for helping coordinate the study operations. This work was supported by Gilead Sciences, Inc., through an investigator-sponsored research initiative. Funding support included expenses for study conduct. B/F/TAF was sourced through the participant’s respective insurance payer or the AIDS Drug Assistance Program.
Funding Information:
Potential conflicts of interest. J. P. H. reports research grants from Gilead Sciences. S. H. B. reports grants from Gilead Sciences, ViiV Healthcare, and Janssen, outside the submitted work. S. S. reports grants from ViiV Healthcare, outside the submitted work. K. K. S. reports research grants from Organon, paid to her institution. All other authors report no potential conflicts.
Publisher Copyright:
© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
PY - 2023/3/1
Y1 - 2023/3/1
N2 - Background. People with human immunodeficiency virus (HIV) and substance use disorder (PWH/SUD) are at higher risk of nonadherence to antiretroviral therapy. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) exhibits high rates of efficacy with a favorable adverse event profile. The BASE study (NCT03998176) is a phase 4, single-arm study evaluating the effectiveness and safety of B/F/TAF among PWH/SUD. Methods. Viremic (HIV RNA >1000 copies/mL) PWH/SUD initiated B/F/TAF once daily for 48 weeks (W). The primary endpoint was proportion of participants with HIV RNA <50 copies/mL at W24. Secondary endpoints were proportion of participants with HIV-1 RNA <50 copies/mL at W48, safety, B/F/TAF adherence (dried blood spot [DBS] concentrations of emtricitabine triphosphate and tenofovir diphosphate [TFV-DP]), substance use (NIDA-ASSIST), and quality of life (SF-12). Results. Forty-three participants were enrolled; 95% reported methamphetamine use. Median age was 38 (range, 21–62) years; 21% were female, 81% White, 14% Black, and 16% Hispanic. Thirty-two (74%) and 21 (49%) participants had HIV RNA <50 copies/ mL (intention-to-treat) at W24 and W48, respectively. Seven participants (16%) experienced confirmed virologic failure through W48; 1 developed emergent drug resistance (M184V). Fifteen participants (35%) experienced grade ≥3 adverse events. Five participants (12%) reported suicidal ideation; none resulted in discontinuation. Median DBS concentrations were representative of 5–6 doses/week (TFV-DP, 1603 fmol/punches). NIDA-ASSIST scores declined from baseline to W48 with methamphetamine use decreasing most (−7.9 points; −29%), and SF-12 physical/mental scores increased 1.2 and 7.6 points, respectively. Conclusions. B/F/TAF among a high-risk population of PWH/SUD resulted in an initial 72% viral suppression rate at W24 before dropping to 49% at W48 as retention declined. One participant developed emergent drug resistance (M184V).
AB - Background. People with human immunodeficiency virus (HIV) and substance use disorder (PWH/SUD) are at higher risk of nonadherence to antiretroviral therapy. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) exhibits high rates of efficacy with a favorable adverse event profile. The BASE study (NCT03998176) is a phase 4, single-arm study evaluating the effectiveness and safety of B/F/TAF among PWH/SUD. Methods. Viremic (HIV RNA >1000 copies/mL) PWH/SUD initiated B/F/TAF once daily for 48 weeks (W). The primary endpoint was proportion of participants with HIV RNA <50 copies/mL at W24. Secondary endpoints were proportion of participants with HIV-1 RNA <50 copies/mL at W48, safety, B/F/TAF adherence (dried blood spot [DBS] concentrations of emtricitabine triphosphate and tenofovir diphosphate [TFV-DP]), substance use (NIDA-ASSIST), and quality of life (SF-12). Results. Forty-three participants were enrolled; 95% reported methamphetamine use. Median age was 38 (range, 21–62) years; 21% were female, 81% White, 14% Black, and 16% Hispanic. Thirty-two (74%) and 21 (49%) participants had HIV RNA <50 copies/ mL (intention-to-treat) at W24 and W48, respectively. Seven participants (16%) experienced confirmed virologic failure through W48; 1 developed emergent drug resistance (M184V). Fifteen participants (35%) experienced grade ≥3 adverse events. Five participants (12%) reported suicidal ideation; none resulted in discontinuation. Median DBS concentrations were representative of 5–6 doses/week (TFV-DP, 1603 fmol/punches). NIDA-ASSIST scores declined from baseline to W48 with methamphetamine use decreasing most (−7.9 points; −29%), and SF-12 physical/mental scores increased 1.2 and 7.6 points, respectively. Conclusions. B/F/TAF among a high-risk population of PWH/SUD resulted in an initial 72% viral suppression rate at W24 before dropping to 49% at W48 as retention declined. One participant developed emergent drug resistance (M184V).
KW - HIV
KW - bictegravir/emtricitabine/tenofovir alafenamide
KW - substance use disorder
UR - http://www.scopus.com/inward/record.url?scp=85153533274&partnerID=8YFLogxK
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U2 - 10.1093/ofid/ofad080
DO - 10.1093/ofid/ofad080
M3 - Article
C2 - 36910693
AN - SCOPUS:85153533274
SN - 2328-8957
VL - 10
JO - Open Forum Infectious Diseases
JF - Open Forum Infectious Diseases
IS - 3
M1 - ofad080
ER -