Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF

Exclusion Criteria

• •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
• •CONCURRENT CONDITIONS/MEDICAL HISTORY
• •1. Women who are breastfeeding or plan to become pregnant or breastfeed during the study.
• •2. Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease \[15\], EXCEPT cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/mm3 are NOT exclusionary.
• •3. Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification \[16\].
• •4. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• •5. Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (antiHBc), Hepatitis B surface antigen antibody (anti-HBs) and HBV DNA as follows:
• •* Subjects positive for HBsAg are excluded.
• •* Subjects negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
• •Note: Subjects positive for anti-HBc (negative HBsAg status) and positive for antiHBs (past and/or current evidence) are immune to HBV and are not excluded. AntiHBc must be either total anti-HBc or anti-HBc immunoglobulin G (IgG), and NOT anti-HBc IgM.
• •6. Anticipated need for any hepatitis C virus (HCV) therapy during the first 48 weeks of the study
• •7. Untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment). Subjects who are at least 7 days post completed treatment are eligible.
• •8. History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
• •9. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.
• •10. Subjects who in the investigator's judgment, poses a significant suicidality risk.
• •EXCLUSIONARY TREATMENTS PRIOR TO SCREENING OR DAY 1
• •11. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
• •12. Treatment with any of the following agents within 28 days of Screening
• •* radiation therapy
• •* cytotoxic chemotherapeutic agents
• •* any systemic immune suppressant
• •13. Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study medication.
• •14. Use of any regimen consisting of single or dual ART LABORATORY VALUES OR CLINICAL ASSESSMENTS AT SCREENING
• •15. Any evidence of major NRTI mutation (defined as history of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), M184V/I, T69-insertions, or K65R/E/N) or presence of any major INSTI resistance-associated mutation \[17\] in any available prior resistance genotype assay test result
• •16. Any verified Grade 4 laboratory abnormality
• •17. Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN) or ALT ≥3xULN and bilirubin ≥1.5xULN (with \>35% direct bilirubin).
• •18. Creatinine clearance of \<50mL/min/1.73m2 via CKD-EPI method.
• •EXCLUSIONARY CRITERIA PRIOR TO SCREENING OR DAY 1
• •19. Within the 6 to 12-month window prior to Screening and after confirmed suppression to \<50 copies/mL, any plasma HIV-1 RNA measurement \>200 c/mL.
• •20. Within the 6 to 12-month window prior to Screening and after confirmed suppression to \<50 copies/mL, 2 or more plasma HIV-1 RNA measurements ≥50 c/mL.
• •21. Within 6 months prior to Screening and after confirmed suppression to \<50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement ≥50 copies/mL.
• •22. Any drug holiday during the 12 months prior to Screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns.
• •23. Any history of switch to another regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV-1 RNA ≥400 copies/mL.