MOVING FORWARD Enhanced ART Monitoring in Countries: Botswana Haruna Jibril, Deputy Permanent Secretary Botswana Ministry of Health and Wellness IAS July 2017

Background Botswana has made remarkable progress in HIV treatment and care since 2002: National prevalence rate of 18.5% (BAIS IV, 2014) National incidence rate of 0.71% (Spectrum 2017) Total HIV Population: 403,326 (31/12/16) ART Coverage of Total HIV Population: 75.2% PMTCT Rate = <1.4% (2016) Recorded deaths since 2002-2014: 23,959 (10.1%) Adults Cumulative First Line Failure Rate: estimated at 12% (2002-2014) (Data sources: BAIS IV, 2013, Spectrum 2017 v.5.57 & DHAPC programmatic data 2017) (PMH-IDCC 5 years Lost to Follow Up Data: n=967)

Background After extensive economic analysis in 2016, it was clear that for Botswana to gain epidemiologic control of HIV - a Treat All Strategy - which included the use Dolutegravir as 1st Line had to be adopted. On 1 June 2017 Treat All was launched. Approximately 30,000 patients have been initiated on DTG, with another 10,000 switched to DTG containing regimens

M&E System Improvements For Treat All Implementation Previously, all basic monitoring of ART indicators was conducted vertically through 34 ARV Sites. In order to mainstream HIV data collection with Treat All, the Site Model was replaced to the National Cluster Model (>90 sites) – no longer isolating HIV information from normal pharmacy and clinical data channels. The DHIS system was also expanded

M&E System Improvements For Treat All Implementation In PEPFAR funded sites (approximately 100) all basic M&E indicators were collected on an innovative SMS reporting system, which allowed the initial information on DTG initiations (toxicities and unexpected averse side effects) to be captured on a weekly basis.

M&E System Improvements For Treat All Implementation For Pregnancy data, Botswana-Harvard Partnership monitors 40% of all deliveries in the country and agreed to add DTG monitoring to their data collection efforts.

M&E System Improvements For Treat All Implementation For TB, the Botswana National Tuberculosis Programme are working closely with research partners U Penn, BUMMHI, and BHP to monitor any unexpected adverse side effects. Nothing unusual has been noticed apart from an initial increase in TB Iris (TB unmasking) primarily due to physician oversights in beginning ART before ruling out TB. Close monitoring continues with expected long-term outcomes available in 2018

M&E System Improvements For Treat All Implementation The Botswana Epidemiological ART Treatment (The BEAT) Study Cohort is prospectively monitoring patients initiated or switched to DTG over three years as compared to Atripla. The BEAT will establish an operational research cohort within the Botswana Ministry of Health and Wellness and is being developed in collaboration with BHP, BUMMHI and the University of Botswana.

Preliminary DTG Outcomes Approximately 40,000 patients are receiving DTG in Botswana (as of 30/6/17) 30,000 First-Line Initiations 10,000 treatment switches to DTG BCPP data as of March 2017, 90% of all initiated on DTG achieved full virologic suppression by 3 months (n>1,000).

Preliminary DTG Outcomes Toxicities / Adverse Side Effects: <1% less than 20 treatment switches primarily due to GI disturbance

See Abstract #MOAX02 (24/7/17 - Rebecca Zash). DTG Outcomes Pregnancy There were no significant differences in safety outcomes between DTG and Atripla in pregnancy. See Abstract #MOAX02 (24/7/17 - Rebecca Zash).

DTG Outcomes Integrase Resistance Monitoring Of 48 First Line failures genotyped only 2 patients were found to have integrase mutations (both previously treated and failing Raltegravir at the time of switch to DTG): - Patient 1: Q148 (went on to fully suppress on DTG) - Patient 2: Q148, E138, N155 (highly treatment experienced)

No Adverse Side Effects Reported to Date DTG Outcomes TB Outcomes Initially higher number of IRIS (TB unmasking) detected – due primarily to physician error initiating before ATT. No Adverse Side Effects Reported to Date Awaiting Year One Reporting

Many Thanks Botswana Ministry of Health Department of HIV/AIDS Prevention & Care Botswana-Harvard Partnership Baylor Children’s Clinical Centre of Excellence BUMMHI Careena Centre for Health CDC-PEPFAR Heston Phillips, UNAIDS University of Botswana