Appendix Table 1.
Number of Sites, Dates of Follow-up, and Initial Policies About Dolutegravir Use for Females of Reproductive Age, by Country
| Country | Sites, n | Earliest Date of Dolutegravir Use in Our Sample | Database Closure Date | Initial Policy About Dolutegravir Use for Females of Reproductive Age After Safety Signal* |
|---|---|---|---|---|
| Start of country dolutegravir implementation before the May 2018 safety signal | ||||
| Brazil | 1 | January 2017† | January 2020 | Women who intend to become pregnant or who are pregnant should not receive dolutegravir. Women of reproductive age must use a contraceptive method preferably not dependent on adherence, e.g., implant or intrauterine device, to access dolutegravir (8). |
| Kenya | 23 | July 2017 | January 2020–February 2020 | Dolutegravir is not recommended for women of childbearing age (15–49 y) and those already receiving it should transition to efavirenz. Pregnant and breastfeeding women who are currently receiving dolutegravir should continue their current regimen until complete cessation of breastfeeding (9). |
| Cambodia | 1 | January 2018 | March 2020 | Adolescent girls and women of childbearing potential who do not currently want to become pregnant can receive dolutegravir together with consistent and reliable contraception. An efavirenz-based regimen is recommended for women desiring pregnancy or women with childbearing potential who do not wish to take contraception (10). |
| Rwanda | 10 | February 2018 | March 2020 | Dolutegravir is contraindicated for all females <50 y (11). |
| Uganda | 1 | February 2018 | March 2020 | Women of reproductive age (15–49 y) are only eligible for dolutegravir if they have long-term contraception (i.e., tubal ligation, implant, intrauterine device). Dolutegravir is recommended for pregnant women starting ART (12). |
| Start of country dolutegravir implementation after the May 2018 safety signal | ||||
| Haiti | 1 | October 2018 | March 2020 | The transition to dolutegravir is inclusive of all women. Programme National de Lutte contre le Sida issued a memo in April 2019 stating that women of reproductive age may choose dolutegravir even in the absence of contraception after counseling on risks and benefits and with informed consent (19). |
| Zimbabwe | 33 | February 2019 | March 2020 | Adolescent girls and women of childbearing potential should be given adequate information to make informed choices about their treatment options. A dolutegravir-containing regimen is recommended if the person has effective contraception (intrauterine device, intrauterine system, implant, injection); otherwise, efavirenz-containing ART is recommended. Women who are pregnant and receiving ART should switch to dolutegravir after their first trimester and continue it while breastfeeding with provision of effective contraception (20). |
| Democratic Republic of the Congo | 1 | February 2019 | March 2020 | The transition to dolutegravir will include women of childbearing potential (21). |
| Mozambique | 8 | May 2019 | March 2020 | Dolutegravir recommended for all adults living with HIV. Efavirenz should be offered to women of reproductive potential age who are planning a pregnancy at the time of starting ART. Women of reproductive age should be offered long-term contraceptive methods (e.g., implant, injection, intrauterine device) (22). Note, earlier in 2019, dolutegravir was only recommended for specific populations (e.g., tuberculosis coinfection) as part of “phase I” of the rollout. |
| Tanzania | 1 | June 2019 | March 2020 | Dolutegravir recommended for all adults and adolescents with HIV, but efavirenz is available for women who choose not to use dolutegravir. A women-centered approach is adopted and women of childbearing potential, including those who are using long-term effective contraception, will be given adequate information to enable them to make informed decision and informed choice consent to using dolutegravir (23). |
| Lesotho | 7 | June 2019 | March 2020 | All women and adolescent girls of childbearing potential should be counseled on the risks and benefits of dolutegravir versus efavirenz and allowed to decide which regimen best suits her needs. Women who do not wish to become pregnant should be offered and encouraged to use consistent and reliable contraception (24). |
ART = antiretroviral therapy.
*
Earliest policies after the safety signal (May 2018) that pertained to dolutegravir use among females of reproductive age were identified. The terminology used reflects that of the source.
†
Twenty patients started a dolutegravir-containing regimen in 2016; however, the earliest use date was revised to January 2017 to reflect when dolutegravir was initially recommended as the first-line regimen in national guidelines.