Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine

Phase 4

Completed

Interventions: Drug: Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch

Brief Summary: The current study proposal is an open label observational trial for maintenance of virologic suppression, and is designed as a non- inferiority switch trial. The study will involve approximately 30 patients, which includes a PK arm of approximately 10 patients. The study will also include secondary outcomes of quality of life (QOL) and weight changes

Hypothesis:

Patients with prior NUC or NNRTI resistance (but not to rilpivirine or doravirine) will maintain their virologic suppression after a drug regimen switch from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine. The switch therapy will avoid food interactions, and will be well tolerated by subjects.

Recruitment & Eligibility

Inclusion Criteria

HIV positive Males, age 45 or older
Any genotypic or phenotypic resistance except k65R, 69 insertion, integrase resistance, or resistance to rilpivarine or doravirine.
Receiving combination antiretroviral regimen of rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir > 12 months and with viral load <50 copies/ mL on at least one occasion within the six months prior to switch.
Suppressed viral load as defined by one plasma HIV RNA level < 50 copies/mL within previous 6 months.
Capable of providing informed consent

Exclusion Criteria

Any current or prior integrase inhibitor resistance
Nucleoside reverse transcriptase (NRTI) mutation 69 insertion or k65R mutation
Documented second generation non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance (rilpivirine or doravirine)

Arm && Interventions

Group	Intervention	Description
Biktarvy + Doravirine Switch	Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch	bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day

Primary Outcome Measures

Name	Time	Method
Viral Suppression	48 Weeks	Percentage of patients with viral HIV load (VL) \<50 and \<200 copies/mL at 48 weeks

Secondary Outcome Measures

Name	Time	Method
PK Assessment	Week 4 (+/- 14 days) with time points at predose (-0.5 hr), 0.5, 1, 2, 4, 6, 8, 12, and 24 hours	Subject plasma concentration-time data of bictegravir and doravirine will be analyzed using non-compartmental model (WinNonlin®)
Adverse Events Assessment	Day 28, Weeks 12, 24, 36, & 48	Assess AE's of any grade and relationship to the drug combination occurring in at least 5% of participants or more.
Wellbeing Improvement	Week 48	Improvement in well-being and sleep inventory as measured by The Pittsburgh Sleep Quality Index (PSQI). Minimum score is 0 and maximum score is 21. A higher score indicates worse quality sleep.
Tolerability of Study Drug	Week 48	Tolerability of study drugs will be assessed by summarizing the number of AE/SAEs occurring during the study
Work Productivity and Activity	Week 48	Improvement in work productivity and activity as measured by Work Productivity and Activity Impairment Questionnaire (WPAI). The range of the scale is 0-10, where 0 means it did not have an affect and 10 means it did have an affect.
Change in Body Mass Index	Week 48	Assess changes in BMI due to treatment switch