Table 4 Adverse events occurring between baseline and week 96

From: Cabotegravir and rilpivirine for treatment of HIV infection in Africa: week 96 results from the phase 3b randomized, open-label, noninferiority CARES trial

 

Long-acting therapy (n = 255)

Oral therapy (n = 257)

Difference (95% CI)*

Participants with at least one adverse event grade ≥3, no. (%)

 Any

41 (16)

22 (9)

7.5 (1.9 to 13.2)

 Related to study drug†

5 (2)

4 (2)

0.4 (−1.9 to 2.7)

Participants with at least one serious adverse event, no. (%)

 Any

12 (5)

9 (4)

1.2 (−2.2 to 4.6)

 Related to study drug

0

 

–

Participants with at least one HIV disease progression event, no. (%)

 Any

2

2

–

 Death‡

1

1

–

 AIDS-defining event

0

0

–

 Serious non-AIDS event‡

1

2

–

Participants with at least one adverse event of any grade, no. (%)

 Any

230 (90)

185 (72)

18.2 (11.6 to 24.8)

 Leading to study drug discontinuation

2 (1)

5 (2)

−0.8 (−2.6 to 1.1)

 Excluding injection-site reactions

202 (79)

185 (72)

7.2 (−0.2 to 14.6)

 Injection-site reactions

197 (77)

0

–

  1. Data are n (%). The table presents the number of participants with at least one adverse event in each event category.
  2. *Differences are expressed in percentage points. Estimates of difference and 95% CI used the normal approximation to the binomial method.
  3. †Grade ≥3 adverse events considered at least possibly related to study drug were injection-site nodule in one participant, increased low-density lipoprotein cholesterol in two participants, proteinuria in one participant and increased blood triglycerides in one participant in the long-acting group; and decreased estimated glomerular filtration rate (eGFR) in two participants, increased aspartate aminotransferase in one participant and increased blood glucose in one participant in the standard oral therapy group.
  4. ‡Death was due to postoperative complications of surgery for strangulated umbilical hernia for the participant in the long-acting group; and due to encephalopathy associated with parapharyngeal squamous cell carcinoma for the participant in the oral therapy group. Serious non-AIDS events were lung adenocarcinoma in one participant in the long-acting group; and parapharyngeal squamous cell carcinoma (fatal) and prostate adenocarcinoma in one participant each in the oral therapy group.
  5. Adverse events leading to study drug discontinuation were injection-site sterile abscess and lung adenocarcinoma each in one participant in the long-acting treatment group (switched to standard oral treatment); osteoporosis in two participants (one switched tenofovir to abacavir and the other switched tenofovir to zidovudine), decreased eGFR in one participant (switched tenofovir to abacavir), increased blood glucose in one participant (switched dolutegravir to efavirenz) and increased aspartate aminotransferase in one participant (switched dolutegravir to efavirenz) in the standard oral therapy group. In addition, two participants in the standard oral therapy group with low eGFR at baseline switched tenofovir to abacavir during follow-up to prevent further decline in eGFR.
Back to article page