Table 1.
Main model input parameters
| Base case value | Sensitivity analyses (4)
|
References | ||
|---|---|---|---|---|
| Range | Type | |||
|
|
|
|
||
| Baseline characteristics | ||||
| Mean age, years (SD) | 33.6 (7.7) | [26 – 41] | CI | (24) |
| Mean CD4, cells/μl (SD) | 154 (102) | [52 – 256] | CI | (20) |
| Sex, female, % | 100 | |||
| Plasma HIV-1 RNA, copies/ml, % | ||||
| >100,000 | 52.6 | (24) | ||
| 30,001–10,0000 | 21.8 | (24) | ||
| 10,001–30,000 | 13.1 | (24) | ||
| 3,001–10,000 | 5.5 | (24) | ||
| 501–3,000 | 3.1 | (24) | ||
| ≤ 500 | 3.9 | (24) | ||
| Monitoring | ||||
| Interval between clinic visits, months | 3 | 1; 6 months | Extr. values | ASMPT |
| Interval between CD4 tests, months | 6 | 3; 12 months | Extr. values | ASMPT |
| First-line ART efficacy and toxicity | ||||
| HIV-1 RNA suppression at 24 weeks, % (1) | 80.2 | [65 – 85] | Extr. Values | (2, 20) |
| CD4 cell/μl increase at 24 weeks (1) | 152 | (20)* | ||
| Toxicity, % | ||||
| EFV: | ||||
| Drug discontinuation | 0.1 | [0 – 6.3] | Extr. values | (8) |
| Fatal toxicity (2) | 0.1 | [0 – 1.0] | Extr. values | (27) |
| NVP: | ||||
| Drug discontinuation | 6.3 | [4.3 – 8.3] | CI | (8) |
| Fatal toxicity (2) | 1.0 | [0 – 3.0] | Extr. values | (28) |
| Pregnancy | ||||
| Pregnancy rate, per 100 woman-years (3) | 7.9 | [5.0 – 15.0] | Extr. values | (9) |
| Outcomes, % | ||||
| Abortion | 11.7 | (29) | ||
| Miscarriage | 5.2 | (29) | ||
| Stillborn | 6.7 | (29) | ||
| Live births (3) | 76.4 | [60.0 – 85.0] | Extr. values | (29) (9, 34) |
| Birth defects, % | ||||
| EFV | 2.9 | (30) | ||
| NVP | 2.7 | (30) | ||
EFV: ART regimen including efavirenz and 2 nucleoside reverse transcriptase inhibitors (tenofovir + emtricitabine); NVP: ART regimen including nevirapine and 2 nucleoside reverse transcriptase inhibitors (tenofovir + emtricitabine);
In the base case analysis we assumed that EFV and NVP had the same immunological and virological efficacy;
In the base case analysis we assumed that 0.1% of the 0.1% patients who had major toxicity on EFV died (0.001 × 0.001 = 0.00001), and 1% of the 6.3% patients who had major toxicity on NVP died (0.063 × 0.01 = 0.00063);
In the base case analysis we assumed that women on EFV or NVP had the same rate of pregnancy and live birth;
In one-way sensitivity analysis, we varied each parameter within the range of confidence interval (CI) or of highest or lowest values (Extreme values - Extr.values) as found in the literature. The column ‘references’ refers to the papers where CI and extreme values were found (ASMPT: assumption).