Table 2.
Virologic Outcomes at Week 256 by United States Food and Drug Administration Snapshot Algorithm
| Outcome | ITT, Maintenance-Exposed, Randomized Population | Extension-Switch Population | ||
|---|---|---|---|---|
| Q8W IM | Q4W IM | Q8W IM | Q4W IM | |
| (n = 115) | (n = 115) | (n = 34) | (n = 10) | |
| HIV-1 RNA <50 copies/mL | 101 (88) | 85 (74) | 32 (94) | 9 (90) |
| HIV-1 RNA ≥50 copies/mL | 4 (3) | 0 | 1 (3) | 0 |
| Discontinued for lack of efficacy | 1 (<1) | 0 | 1 (3) | 0 |
| Discontinued for other reasons | 3 (3)a | 0 | … | … |
| No virologic data | 10 (9) | 30 (26) | 1 (3) | 1 (10) |
| Discontinued due to AE or deathb | 2 (2)c | 18 (16)d,e | 1 (3)f | 1 (10)g |
| Discontinued for other reasons | 8 (7) | 11 (10) | … | … |
| Missing data during window but on study | 0 | 1 (<1) | … | … |
Data are presented as No. (%).
Abbreviations: AE, adverse event; HIV-1, human immunodeficiency virus type 1; IM, intramuscular; ITT, intention to treat; Q4W, every 4 weeks; Q8W, every 8 weeks.
aIncludes consent withdrawal due to injection intolerability.
bParticipants could have ≥1 AE leading to withdrawal.
cChills, injection site pain, injection site pruritus, and pain (n = 1); hepatitis C virus infection (n = 1).
dThree deaths occurred due to epilepsy (unrelated to study treatment), toxicity to various agents (unrelated to study treatment), and myocardial infarction (drug related).
eAcute kidney injury, adjustment disorder with depressed mood, coronary artery disease, deep venous thrombosis, drug abuse, eosinophilic granulomatosis with polyangiitis, epilepsy, fatigue, hepatitis C virus infection, hypoesthesia, injection site nodule, injection site pain, lymphadenopathy, mesenteric vein thrombosis, metabolic acidosis, motor neuron disease, muscular weakness, myocardial infarction, portal vein thrombosis, prolonged QT interval, psychotic disorder, rash, respiratory tract infection, rhabdomyolysis, sinus tachycardia, splenic vein thrombosis, suicide attempt, and toxicity to various agents.
fBack pain, conjunctival hyperemia, erythema, and papular urticaria.
gInjection site pain.