Table 2.
Predicted effects of policy options over 20 years
| ART initiation with tenofovir, lamivudine, and efavirenz in women intending pregnancy* | ART initiation with tenofovir, lamivudine, and dolutegravir in women intending pregnancy* | ||
|---|---|---|---|
| Proportion of women intending pregnancy on ART who are on† | |||
| Dolutegravir | 0% | 48%, 48% (48 to 48; 37 to 57) | |
| Efavirenz | 92% | 46%, −46% (−46 to −46; −56 to −33) | |
| Atazanavir‡ | 8% | 6%, −2% (−2 to −2; −7 to 0) | |
| Tenofovir | 92% | 94%, 2% (2 to 2; 0 to 7) | |
| Lamivudine | 100% | 100%, 0% (0 to 0; 0 to 0) | |
| Zidovudine | 8% | 6%, −2% (−2 to −2; −7 to 0) | |
| Proportion of women intending pregnancy with viral load <1000 copies per mL 12 months from ART initiation† | 74% | 80%, 6% (6 to 6; 0 to 12) | |
| Proportion of women intending pregnancy on ART with viral load <1000 copies per mL 12 months from ART initiation† | 82% | 88%, 6% (6 to 6; 1 to 13) | |
| Proportion of women intending pregnancy on ART with viral load <1000 copies per mL† | 84% | 89%, 5% (5 to 5; 1 to 10) | |
| In women intending pregnancy on ART at 12 months from start of ART, change in CD4 cell count per μL† | 132 | 151, 20 (19 to 20; 1 to 43) | |
| Proportion of all HIV-positive people with:† | |||
| Efavirenz resistance | 23% | 19%, −4% (−4 to −4; −9 to −1) | |
| Dolutegravir resistance | 1% | 2%, 1% (1 to 1; 0 to 3) | |
| Death rate in women intending pregnancy on ART (per 100 person-years)† | 1·78 | 1·42, −0·36 (−0·38 to −0·034; −1·00 to −0·01) | |
| HIV-related | 1·03 | 0·65, −0·38 (−0·40 to −0·036; −1·02 to −0·05) | |
| Non-HIV-related | 0·76 | 0·78, 0·02 (0·02 to 0·02; 0·07 to 0·12) | |
| Outcomes for babies—annual number of cases of:† | |||
| Neural tube defects | 1 | 73, 72 (69 to 74; 15 to 156) | |
| Mother-to-child transmission | 9650 | 8150, −1500 (−1400 to −1600; −4450 to 0) | |
| Excess stillbirths or neonatal death due to dolutegravir-induced increase in BMI | 1 | 43, 42 (40 to 45; 0 to 124) | |
| Mean total DALYs averted per year compared with tenofovir, lamivudine, and efavirenz (DALYs in adults, DALYs due to neural tube defects and other dolutegravir-induced obesity-related adverse neonatal events) | .. | 10 990 (10 248, 11 732; −7075 to 31 840) | |
| Breakdown of mean total DALYs averted per year compared with tenofovir, lamivudine, and efavirenz | |||
| Before accounting for neural tube defects, prevention of mother-to-child transmission, and morbidity effects of weight gain | .. | 10 970 | |
| Neural tube defects | .. | −270 | |
| Mother-to-child transmission | .. | 510 | |
| Excess risk of stillbirth or neonatal death due to dolutegravir-induced increase in BMI | .. | −170 | |
| Pre-death morbidity due to weight gain | .. | −40 | |
| Mean cost over 3-month periods from 2019 to 2039 (millions of US$, discounted at 3% per year)§ | |||
| Total | 195·7 | 192·9 (difference −2·9) | |
| HIV tests | 10·8 | 10·7 | |
| Efavirenz | 18·2 | 13·0 | |
| Dolutegravir | 4·7 | 10·2 | |
| Lamivudine | 19·8 | 19·9 | |
| Tenofovir | 27·4 | 27·9 | |
| Zidovudine | 4·4 | 3·9 | |
| Atazanavir | 13·1 | 11·4 | |
| Clinic visits (non-ART programme costs) | 55·0 | 55·1 | |
| Treatment or care for WHO stage 3 or 4 events | 12·4 | 11·5 | |
| Viral load tests | 7·4 | 7·3 | |
| Treatment for children because of mother-to-child transmission | 6·9 | 6·3 | |
| Non-AIDS pre-death morbidity | 14·4 | 14·5 | |
| CD4 counts | 0·5 | 0·5 | |
| Adherence counselling | 0·2 | 0·1 | |
| Cost in staff time of switching to second-line ART | 0·1 | 0·1 | |
| Net DALYs averted per year | .. | 16 735 | |
ART=antiretroviral therapy. BMI=body-mass index. DALY=disability-adjusted life-year.
ART initiated in men and women not wanting (more) children is tenofovir, lamivudine, and dolutegravir.
Data in the first column are the mean over 3-month periods from 2019 to 2039 for each policy. Data in the second column are the mean, mean absolute difference (95% CI; 90% range reflecting variation across setting scenarios) compared with the policy of first-line tenofovir, lamivudine, and efavirenz in women intending pregnancy.
We assume atazanavir is used as the protease inhibitor in second-line ART.
Cost breakdown by regimen policy (for all adults in context of a population of 10 million adults). Tenofovir, lamivudine, and dolutegravir and tenofovir, lamivudine, and efavirenz are assumed to cost $75 per year, atazanavir $265 per year (Global Fund procurement list of drug costs, July 201821). Viral load test costs reflect that in some setting scenarios viral load testing is minimally implemented—the total cost is double this mean cost if fully implemented.