Patient-reported tolerability and acceptability of cabotegravir + rilpivirine long-acting injections for the treatment of HIV-1 infection: 96-week results from the randomized LATTE-2 study

Figures & data

Figure 1 LATTE-2 study design. IM, intramuscular; PO, oral; Q4W, every 4 weeks; Q8W, every 8 weeks; QD, once daily. ^aParticipants who withdrew after at least 1 IM dose entered the long-term follow-up period.

Table 1 Item content in the HIVTSQ[s] and HIVTSQ[c] versions.^11,a

Item number	Item label	Item wording	Response options 6–0
			HIVTSQ[s]^b	HIVTSQ[s]^c
1	Current treatment^d	How satisfied are you with your current treatment?	6 (very satisfied) to 0 (very dissatisfied)	3 (much more satisfied now) to −3 (much less satisfied now)
2	Control^d	How well controlled do you feel your HIV has been recently?	6 (very well controlled) to 0 (very poorly controlled)	3 (much more controlled now) to −3 (much less controlled now)
3	Side effects^d	How satisfied are you with any side effects of your present treatment?	6 (very satisfied) to 0 (very dissatisfied)	3 (much more satisfied now) to −3 (much less satisfied now)
4	Demands^e	How satisfied are you with the demands made by your current treatment?	6 (very satisfied) to 0 (very dissatisfied)	3 (much more satisfied now) to −3 (much less satisfied now)
5	Convenience^e	How convenient have you been finding your treatment to be recently?	6 (very convenient) to 0 (very inconvenient)	3 (much more convenient now) to −3 (much less convenient now)
6	Flexibility^e	How flexible have you been finding your treatment to be recently?	6 (very flexible) to 0 (very inflexible)	3 (much more flexible now) to −3 (much less flexible now)
7a	Understanding^e	How satisfied are you with your understanding of your HIV?	6 (very satisfied) to 0 (very dissatisfied)	3 (much more satisfied now) to −3 (much less satisfied now)
7b		How satisfied are you with your understanding of your HIV treatment?	6 (very satisfied) to 0 (very dissatisfied)	3 (much more satisfied now) to −3 (much less satisfied now)
8	Lifestyle^e	How satisfied are you with the extent to which the treatment fits in with your lifestyle?	6 (very satisfied) to 0 (very dissatisfied)	3 (much more satisfied now) to −3 (much less satisfied now)
9a	Recommend to others^d	How likely would you be to recommend your present treatment to someone else with HIV?	6 (yes, I would definitely recommend) to 0 (no, I would definitely not recommend)	3 (much more likely to recommend) to −3 (much less likely to recommend)
9b		How likely would you be to speak well of your present treatment to someone else who is being offered this HIV treatment?	6 (yes, I would definitely recommend) to 0 (no, I would definitely not recommend)	3 (much more likely to recommend now) to −3 (much less likely to recommend now)
10	Continue^d	How satisfied would you be to continue with your present form of treatment?	6 (very satisfied) to 0 (very dissatisfied)	3 (much more satisfied now) to −3 (much less satisfied now)
11	Ease/difficulty of treatment^f	How easy or difficult have you been finding your treatment to be recently?	6 (very easy) to 0 (very difficult)	3 (much easier now) to −3 (much more difficult now)
12	Pain/discomfort^f	How satisfied are you with the amount of discomfort or pain involved with your present form of treatment?	6 (very satisfied) to 0 (very dissatisfied)	3 (much more satisfied now) to −3 (much less satisfied now)

HIVTSQ: HIV Treatment Satisfaction Questionnaire; HIVTSQ[c]: HIV Treatment Satisfaction Questionnaire, change version; HIVTSQ[s]: HIV Treatment Satisfaction Questionnaire, status version.

^a Total scores were derived as the sum of responses to questions 1–6, 7a, 8, 9a, 10, and 11.

^b Participant instructions were: “The following questions are concerned with your anti-HIV medicine therapy for HIV infection and your experience over the past few weeks.”

^c Participant instructions were: “The following questions are concerned with your present anti-HIV medicine therapy compared with your experience of induction treatment of two tablets per day. We are interested to know how, if at all, your experience of medicine therapy has changed.”

^d Items included in the general satisfaction/clinical subscale in the original version of the HIVTSQ.

^e Items included in the lifestyle/ease subscale in the original version of the HIVTSQ.

^f Added to the standard HIVTSQ specifically for the present study.

Reprinted from Value Health, 9(5), Woodcock A and Bradley C, Validation of the revised 10-item HIV Treatment Satisfaction Questionnaire status version and new change version, 320–333, Copyright 2006, with permission from Elsevier.

Figure 2 Participants reporting ISRs by visit through Week 96 of the maintenance period. AE, adverse event; IM, intramuscular; ISR, injection-site reaction; Q4W, every 4 weeks; Q8W, every 8 weeks. In the Q8W group, one participant completed the maintenance phase but did not receive injections at Week 96.

Table 2 Injection-site reactions in the cabotegravir + rilpivirine long-acting injectable treatment groups during the maintenance period through week 96.

	4-Week group (n = 115)	8-Week group (n = 115)	LA injectable subtotal (N = 230)
Total injections administered, n^a	5419	3160	8579
ISRs, n (%)^b	2435 (45)	1925 (61)	4360 (51)
ISRs by severity, n^a (%)
Grade 1	2105 (86)	1543 (80)	3648 (84)
Grade 2	314 (13)	359 (19)	673 (15)
Grade 3	14 (<1)	16 (<1)	30 (<1)
ISR duration
Duration lasting ≤7 days, n^a (%)	2172 (89)	1718 (89)	3890 (89)
Duration of event, median, days	3	3	3
Drug-related ISRs affecting ≥25% of participants in any arm, n (%)
Injection-site pain	112 (97)	109 (95)	221 (96)
Injection-site swelling	34 (30)	29 (25)	63 (27)
Injection-site nodule	35 (30)	29 (25)	64 (28)
Injection-site pruritus	33 (29)	24 (21)	57 (25)

ISR: injection-site reaction; LA: long acting.

^a n refers to number of injections, not number of participants.

^b No ISRs of grade ≥4 were reported in the LA injectable treatment groups.

Figure 3 Amount of pain/discomfort with cabotegravir LA + rilpivirine LA versus oral cabotegravir plus abacavir/lamivudine at Week 8 and Week 96 (HIVMQ, item F). Unlabeled bar values corresponding to item scores 3–6 represent ≤8% of respondents per bar. HIVMQ, HIV Medication Questionnaire; LA, long acting.

Table 3 Change over time in patient-reported inconvenience associated with cabotegravir and rilpivirine injections and oral tablet therapy (HIVMQ).

Item	Cabotegravir LA + rilpivirine LA^a				Oral tablet therapy
	4-Week group		8-Week group		Cabotegravir		Abacavir/ Lamivudine
n (%)	Week 8 (n = 114)	Week 96 (n = 101)	Week 8 (n = 114)	Week 96 (n = 108)	Week 8 (n = 54)	Week 96 (n = 46)	Week 8 (n = 51)	Week 96 (n = 44)
How often do you find it inconvenient or difficult to take/receive this medication as recommended?^b
0, none of the time	76 (67)	67 (66)	80 (70)	82 (76)	21 (39)	18 (39)	20 (39)	17 (39)
1	10 (9)	14 (14)	9 (8)	12 (11)	7 (13)	10 (22)	7 (14)	10 (23)
2	6 (5)	1 (<1)	3 (3)	1 (<1)	4 (7)	3 (7)	4 (8)	2 (5)
3	1 (<1)	1 (<1)	2 (2)	0	1 (2)	2 (4)	1 (2)	2 (5)
4	1 (<1)	4 (4)	1 (<1)	3 (3)	5 (9)	1 (2)	4 (8)	1 (2)
5	4 (4)	6 (6)	4 (4)	2 (2)	10 (19)	9 (20)	9 (18)	9 (20)
6, all of the time	15 (13)	6 (6)	13 (11)	8 (7)	6 (11)	3 (7)	6 (12)	3 (7)
Missing	1 (<1)	2 (2)	2 (2)	0

HIVMQ: HIV Medication Questionnaire.

^a The combined response is the mean value of the individual medication responses, rounded to the nearest integer with values halfway between integers rounded up (eg, 0.5 rounded to 1). If the response for one or both medications was missing, the combined response for that item was categorized as “missing.”

^b Item E from the HIVMQ.

Figure 4 (A) HIVTSQ[s] total scores at Day 1, Weeks 8, and 96. Boxplot values represent the median (center) and first and third quartiles (bottom and top); error bars represent the minimum and maximum scores. Comparisons made using the Wilcoxon rank sum test. Q4W, n = 100; Q8W, n = 108; PO, n = 46. (B) Response scores by item label on the general satisfaction/clinical subscale of the HIVTSQ[c] for participants on LA injectable therapy at Week 32 compared with oral treatment prior to randomization. Item responses were recoded and grouped from the questionnaire’s seven-point scale as a post hoc analysis: less favorable versus induction treatment, −3 to −1; neutral versus induction treatment, 0; more favorable versus induction treatment, 1–3. Unlabeled bar values correspond to ≤4% of respondents per bar. Q4W, n = 100; Q8W, n = 107; PO, n = 49. (C) Response scores by item label on the lifestyle/ease subscale of the HIVTSQ[c] for participants on LA injectable therapy at Week 32 compared with oral treatment prior to randomization. Item responses were recoded from questionnaire’s seven-point scale: less favorable versus induction treatment, −3 to −1; neutral versus induction treatment, 0; more favorable versus induction treatment, 1–3. Unlabeled bar values correspond to ≤4% of respondents per bar. Q4W, n = 100; Q8W, n = 107; PO, n = 49. HIVTSQ[c], HIV Treatment Satisfaction Questionnaire, change version; HIVTSQ[s], HIV Treatment Satisfaction Questionnaire, status version; LA: long acting; PO: once-daily oral tablets; SD: standard deviation; Q4W: cabotegravir LA + rilpivirine LA once every 4 weeks; Q8W: cabotegravir LA + rilpivirine LA once every 8 weeks. *P = 0.02 (post hoc) compared with oral dosing at Week 96. **P < 0.001 (post hoc) compared with oral dosing at Week 96. ^aItems added to the standard HIVTSQ specifically for the LATTE-2 study.

Woodcock A, Bradley C. Validation of the revised 10-item HIV Treatment Satisfaction Questionnaire status version and new change version. Value Health. 2006;9(5):320–333.

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Data availability

Anonymized individual participant data and study documents can be requested for further research from www.clinicalstudydatarequest.com.