Table 3 Characteristics of the four participants with virological failure

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

 

Participant 1

Participant 2

Participant 3

Participant 4

Injection adherence and virological failure

Time in trial at virological failure, weeks

48

48

72

72

Delayed injections (>7 days from target), n (%)

0

0

0

0

Viral load, copies ml−1

8608; 1612

44984; no repeat

798; 563

259; 16161

Rilpivirine resistance mutations*

V108I, E138K

K103N/S, V106V/A, E138A, M230M/L

Test failed

E138A

Rilpivirine resistance level

Intermediate

High

Test failed

Low

Cabotegravir resistance mutations*

E92E/V, N155H, L74M

G118R

Test failed

Q148R (M50I)

Cabotegravir resistance level

Intermediate

High

Test failed

High

Dolutegravir resistance level

Potential low

High

Test failed

Low

NRTI mutations*

Nil

Nil

Nil

Nil

Outcome after failure

Viral load resuppressed on TLD

Died (unrelated cause)

Viral load resuppressed on TLD

Viral load resuppressed on TLD

Baseline characteristics and treatment course

Sex

Female

Male

Male

Male

BMI, kg m2

25.9

22.0

22.2

19.9

Duration of prior antiretroviral therapy, months

24

28

33

12

Prior exposure to NNRTI

No

No

Yes

No

Antiretroviral therapy regimen at baseline

TLD

TLD

TLD

TLD

Viral subtype

A1

D

A1

C

Rilpivirine resistance mutations§

Nil

K103N/S, E138A

E138A

Nil

Rilpivirine resistance level

Nil

Low

Low

Nil

Cabotegravir resistance mutations§

L74M

Nil

Test failed

Nil

Cabotegravir resistance level

Low

Nil

Test failed

Nil

  1. TLD, tenofovir, lamivudine and dolutegravir.
  2. *Resistance mutations listed in the 2022 edition of the International Antiviral Society-USA drug resistance mutations list.
  3. Susceptibility determined using Stanford risk algorithm
  4. Baseline subtype was determined from sequencing of DNA extracted from peripheral blood mononuclear cells. Subtype was identified from reverse transcriptase sequence and determined by reference to the Los Alamos National Laboratory HIV Sequence Database.
  5. §Baseline resistance mutations were determined from sequencing of DNA extracted from peripheral blood mononuclear cells. Resistance mutations listed in the 2022 edition of the International Antiviral Society-USA drug resistance mutations list. None of the baseline sequences had APOBEC mutations.