Efficacy and Safety of a First line Regimen with FTC/TAF Plus Either BIC or DTG
Introduction
According to international guidelines, integrase strand transfer inhibitors (INSTIs) have become the cornerstone of modern antiretroviral regimens (ARV) for the treatment of People Living With HIV (PLWHIV). Bictegravir (BIC) and dolutegravir (DTG), two specific INSTIs, have rapidly become the most used "third" agents in standard first-line 3-drug regimens due to their excellent effectiveness, high genetic barrier to resistance, and favorable safety profile.
Aim
To compare the efficacy and safety of BIC and DTG when prescribed in association with emtricitabine/tenofovir alafenamide (FTC/TAF) as part of a first-line regimen for the treatment of HIV-1 infection.
Patient Profile
Treatment naïve People Living With HIV (PLWHIV)
Table 1: Baseline characteristics
|
Variables |
BIC group (n=187) |
DTG group (n=140) |
p- value |
|
|
Age, median (IQR) |
42 (33-52) |
45 (34-55) |
0.088 |
|
|
Male sex, n (%) |
149 (79.7) |
114 (81.4) |
0.351 |
|
|
HIV risk factors: |
|
|
0.001 |
|
|
MSM |
84 (44.9) |
70 (50.0) |
|
|
|
Heterosexual |
89 (47.6) |
45 (32.1) |
|
|
|
IDUs |
6 (3.2) |
8 (5.7) |
|
|
|
Other/Unknown |
8 (4.3) |
17 (12.1) |
|
|
|
CDC stage C, (%) |
18.2 |
15.7 |
0.461 |
|
|
Median log10 HIV-RNA copies/ml |
4.97 |
5.31 |
0.005 |
|
|
Median CD4+ cells at baseline |
340 |
120 |
<0.001 |
|
|
Median CD4/CD8 ratio |
0.25 |
0.17 |
0.275 |
|
|
HCV-Ab positive |
4 (2.1) |
2 (1.4) |
0.351 |
|
|
HBsAg positive |
3 (1.6) |
1 (0.7) |
0.594 |
|
|
Primary HIV infection |
12 (6.4) |
2 (1.4) |
0.517 |
Methods
- Retrospective study
- Data analyzed from 327 PLWHIV: 140 in the DTG group and 187 in the BIC group.
- Treatment-naïve PLWHIV starting a first line regimen with either BIC/FTC/TAF (BIC group) or FTC/TAF+DTG (DTG group).
- Virological efficacy was evaluated using snapshot analyses after 24 and 48 weeks
- Differences in the rate of treatment discontinuation (TD, defined as the interruption of one or more molecules in the prescribed regimen) between the two groups was evaluated
- Viro-immunological parameters (i.e. HIV-RNA, CD4+ cell count, CD4/CD8 ratio), hepatitis B and hepatitis C serostatus at HIV diagnosis and during follow-up.
Results
- PLWHIV in both groups had a HIV-RNA below 50 copies/mL after 48 weeks from treatment initiation
Figure 1:
- During 173.2 Patient-Years of Follow-Up (PYFU),
- 88 treatment discontinuations were reported in the DTG group and 38 in the BIC group
- Estimated probabilities of maintaining study regimen at week 48 were 59.5% in the DTG group and 84.2% in the BIC group
- Significant improvement in CD4+ cell count was observed in both groups after 48 weeks.
- Median improvement of +169 cell/mm3 (p<0.001) in the DTG group and +233 cell/mm3 (p<0.001) in the BIC group
Conclusion
- BIC and DTG combined with FTC/TAF are both effective and safe first-line strategies in clinical practice, promoting rapid immune recovery.
Reference
Int. J. Antimicrobic. Agents (2023), doi: https://doi.org/10.1016/j.ijantimicag.2023.107040
