Safety and Survival Rates of Dolutegravir versus Efavirenz -Based ART Among HIV Patients
Introduction
Dolutegravir (DTG) is available in a once-daily dosing for HIV patients and is safe, has high genetic barrier to resistance compared to non-DTG-based combination anti-retroviral therapy (cART). DTG based regimen reduces the pill burden, has no significant drug interactions, does not require a booster, and has good absorption regardless of food intake.
Aim
To determine the safety and changes in immunologic and virologic parameters of DTG compared with efavirenz (EFV)-based ART as first-line HIV treatment among HIV patients
Patient Profile
- HIV patients >3 years old, who had been on either DTG or EFV-based combination anti-retroviral therapy (cART), and had detectable viral load (VL)
Methods
- Retrospective hospital-based cohort study
- 990 HIV patients were included in the analysis
- DTG n=694
- EFV n=296
- Demographic and clinical data from the medical records of HIV-infected patients who had a follow-up at an HIV treatment center between September 1, 2019 and August 30, 2020 were included
- Survival rates in months, using the time interval between the dates of VL measurements, were estimated by Kaplan–Meier, and differences in survival rates were tested by the log-rank statistic.
Results
- The mean survival time using Kaplan–Meier analysis was 10.86 months
- Both regimens showed significant viral load reduction
- DTG group 91.6% vs 85.5% in EFV-based regimen (p=0.003)
Figure 1: Proportion of patients achieving VL of <50 copies/mL in the DTG group and % in the EFV group
- Change from baseline in the CD4+ T-cell count was higher in the DTG group than in the EFV group (increase of 139 cells/ mm3 vs 100 cells/mm3) at one year
- Higher proportion of patients had virologic failure (VL of >1000 copies/mL) in the EFV group than in the DTG-based regimen (2.70% vs 1.59%)
Safety
- 42% of the patients in the DTG group reported adverse drug events (ADEs) compared with 50% in the EFV group (p=0.020)
- A greater, but non-significant, average weight gain was observed in the DTG group than in the EFV group (0.39 kg vs 0.32 kg), (p=0.647).
- Adherence to treatment was better in the DTG group than for EFV-based regimens: 83% on the DTG-based regimen versus 71% on the EFV-based regimen had good adherence (p<0.001)
Table 1: Frequencies of Adverse Drug Events Experienced by HIV Patients Treated with DTG or EFV-Based Regimens (n=990)
|
Adverse Drug Event |
Regimen |
Total |
||
|
|
DTG Based |
EFV Based |
|
|
|
No ADE |
405 (58.4%) |
149 (50.3%) |
554 (56.0%) |
|
|
Diarrhea |
63 (9.1%) |
37 (12.5%) |
100 (10.1%) |
|
|
Nausea |
38 (5.5%) |
26 (8.8%) |
64 (6.5%) |
|
|
Headache |
24 (3.5%) |
12 (4.1%) |
36 (3.6%) |
|
|
URTI |
15 (2.2%) |
5 (1.7%) |
20 (2.0%) |
|
|
Insomnia |
42 (6.1%) |
23 (7.8%) |
65 (6.6%) |
|
|
Vomiting |
15 (2.2%) |
9 (3.0%) |
24 (2.4%) |
|
|
Nasopharyngitis |
18 (2.6%) |
4 (1.4%) |
22 (2.2%) |
|
|
Cough |
9 (1.3%) |
5 (1.7%) |
14 (1.4%) |
|
|
Depression |
9 (1.3%) |
6 (2.0%) |
15 (1.5%) |
|
|
Pyrexia |
9 (1.3%) |
5 (1.7%) |
14 (1.4%) |
|
|
Fatigue |
13 (1.9%) |
3 (1.0%) |
16 (1.6%) |
|
|
Dizziness |
12 (1.7%) |
3(1.0%) |
15 (1.5%) |
|
|
UTI |
16 (2.3%) |
6 (2.0%) |
22 (2.2%) |
|
|
Anxiety |
4 (0.6%) |
3 (1.0%) |
7 (0.7%) |
|
|
Lipodystrophy |
2 (0.3%) |
0 |
2 (0.2%) |
|
|
Total |
289 (41.6%) |
147 (49.7%) |
990 (100%) |
|
Abbreviations: ADE, adverse drug event; DTG, dolutegravir; EFV, efavirenz; URTI, upper respiratory tract infection; UTI, urinary tract infection.
Conclusion
- The study showed that DTG-based regimen was associated with improved viral suppression and CD4 cell recovery, and better safety profile CD4+ mm3 compared to EFV-based regimen for the treatment of HIV-infected patients
- Baseline CD4+ T-cell count <200 cells/mm3, OIs, and poor adherence with therapy were factors associated with poor survival and safety outcomes.
Reference
HIV/AIDS - Res. Palliat. Care. 2023:15 173–190.
