TRANSITION TO TLD – ZIMBABWE REPORT TAPIWANASHE KUJINGA AFROCAB MEETING ACCRA, GHANA 13 MAY 2019

INTRODUCTION After the commencement of the Treatment Optimisation project, the main objective of the Zimbabwe CAB was to ensure that dolutegravir was included on the first line regimen. The backbone of the first line ART regimen was efavirenz, and alternatively Nevirapine. The objective was therefore to replace the NNRTI backbone with dolutegravir.

PROJECT IMPLEMENTATION The first step was to meet with project partners CHAI and the government. The Ministry of Health indicated its willingness to adopt DTG into the first line regimen but a decision had already been taken previously to opt for Efavirenz 400mg. During the adaptation process the decision was made to transition to Efavirenz 400pm and dolutegravir became an optional first line ARV. The CAB then decided to embark on an advocacy campaign for the adoption of DTG as the preferred first line backbone ARV.

COMMUNITY ENGAGEMENT Community engagement meetings were held with a number of stakeholders including: Network of people living with HIV Community based organisations Adolescents and young people.

MEETING WITH PEPFAR The CAB members met with PEPFAR to ascertain their attitude. PEPFAR is a significant stakeholder in ART delivery in Zimbabwe as the organisation procures ARV medicines for many ART centres. The decision of PEPFAR was to adopt the procurement of DTG and to discontinue the procurement of Efavirenz. This decision proved to be a game changer.

DTG SWITCH – ADAPTATION PROCESS The Ministry of Health made a decision to switch from Efavirenz to DTG and an Adaptation Committee was set up. In light of the potential NTD complications, the Treatment Optimisation CAB was requested to conduct community dialogues with women living with HIV. A total of 14 dialogues were held with 270 women in October 2018. A presentation was made during a dissemination meeting in February 2019.

ADDENDUM TO GUIDELINES Dolutegravir is not the preferred first line ART backbone for boys, men and women who are not of reproductive potential.

Population Preferred Regimen Alternative Regimen Adult men, adolescents boys and women who are not of child bearing age TDF/ Lamivudine / Dolutegravir TAF/Emtricitabine/ Dolutegravir TDF/Lamivudine/ Efavirenz 400 TDF/Lamivudine/ Efavirenz 600 Women of child bearing potential using “effective contraception”, pregnant women after first trimester

Population Preferred Regimen Alternative Regimen Women of childbearing potential who have no effective contraception including pregnant women in the first trimester Tenofovir/ Lamivudine/ Efavirenz 400 /600 Zidovudine/Lamivudine/ Efavirenz 600 Abacavir/ Lamivudine/

MAIN CONSIDERATIONS Dolutegravir (DTG): is a safe and efficacious drug with a rapid viral suppression, low potential for drug-drug interactions and a high genetic barrier to developing ARV drug resistance. It should be given as a preferred first line regimen for ART naïve patients. Exposure to DTG at the time of conception may be associated with an increased risk of neural tube defects among infants. DTG should not be given to HIV infected pregnant women during their first trimester.

HOW TO TRANSITION ART naïve ? ART experienced? If failing ART? Just use TDF/Lamivudine/Dolutegravir (TLD) ART experienced? ? Evidence of viral suppression over past 12 months Assumes has had annual VL testing VL to have been suppressed <1000 for 12 months If failing ART? Do the usual, enhanced adherence counselling, further VL testing after 3 month etc

OTHER CONSIDERATIONS Use of DTG Not of child bearing potential Effective Contraception reliable long-term contraceptive method i.e. contraceptive intrauterine device (IUD) or intrauterine system (IUS); subdermal contraceptive implant or progestogen injections. HIV/TB using rifampicin, use DTG 50mg bd Adolescents above 30kg can use DTG Avoid TAF in pregnancy and those with HIV/TB & using rifampicin Nevirapine will be phased out! “Woman centred rights vs Public health approach”

SECOND LINE REGIMENS

THIRD LINE REGIMENS

POST-EXPOSURE PROPHYLAXIS

TRANSITION PROCESS Eligible patients are now being switched to DTG and the process is scheduled to be complete in February 2020. The country has large stocks of Efavirenz 400mg hence the long transition period as the objective is to exhaust them first.

NEXT STEPS The CAB members are still not happy with the conditional access to DTG for women of childbearing potential. Engagements with the Ministry will continue especially on the NTD data as it continues to come in from the Tsepamo study and other sources. The ideal situation will be to give women a choice of the ART regimen which they prefer. The CAB and partners will also be conducting pharmacovigilance during the rollout.