BRIEFING NOTES FOR THE MINISTER OF HEALTH: LAUNCH OF FIXED DOSE COMBINATION ARVS, 8 APRIL, 2013 PHEDISONG 4 CHC,

, GA-RANKUWA, GAUTENG BACKGROUND In November 2012, we announced the award of a new ARV tender. During the announcement we said the following and I quote: We have awarded a new tender to the value of R5.9 billion over two years. As you are aware our ARV programme is an expanding one where we have 1.7 million patients on treatment currently and we hope to expand this to 2.5million by the end of 2014. This new tender was initially expected to cost R8.1 billion based on prices of the current tender however in pursuit of affordability and using innovative methods we have been able to reduce the cost of the tender by 38% which is a massive saving of R2.2 billion. In addition to the savings we have also been able to offer patients the latest advance in ARV formulations that is the triple fixed dose combination once daily tablet. We have awarded a tender for the triple fixed dose combination of tenofovir, emtricitabine and efavirenz, which is a single tablet. This in simple language means that a patient does not have to take 3 tablets a day and can now take 1 tablet once a day. So this means that this new tender has moved from an original cost of R8.1 billion to R5.9 billion for 2 years. This saving means we can treat more patients with the same budget. Now because of this new fixed dose combination from April 2013 all pregnant (HIV+) women will be given the fixed dose combination during pregnancy and breast feeding and thereafter if their CD4 count is less than 350. We will also be keeping a register of these patients so we can monitor their progress and check for side effects. This intervention will protect the baby and the mother.

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So 4 months after we awarded the tender here we are at Phedisong CHC to formally launch the implementation of FDCs. You may recall that the manufacturers that we selected were given three months to get ready to supply us with ARVs. PHEDISONG 4 COMMUNITY HEALTH CENTRE The CHC was opened in 2008 and sees about 200 patients a day with 100 deliveries per month. The Health and Wellness Clinic which is attached to the CHC was purchased with PEPFAR funding. The Clinic provides a comprehensive service to HIV positive patients. PREPARATION FOR ROLLOUT Preparation focussed on the following elements: 1. Revision of the guidelines 2. Updating health care workers on the new guidelines 3. Ensuring that the drugs get to the facilities 4. Preparing IEC material 5. Developing a system to monitor implementation Revision of Guidelines We revised the PMTCT, paediatric and adult treatment guidelines. We had to revise these guidelines because of the change in the treatment regime to FDC for both new as well as patient already on ARVs and because we also decided that all pregnant HIV positive women will be started on the FDCs regardless of CD4 count (and that they will stay on treatment until the complete breastfeeding they will continue on treatment should their CD4 be 350 or below). In developing the new guidelines we consulted widely and have received significant inputs from local clinicians and researchers as well as our development partners, including our multilateral partners like WHO, UNICEF and UNAIDS. I wish to take this opportunity to thank them for their contributions. Update of Health Professionals trained to manage HIV patients on New Guidelines. To date more than 7 000 doctors and nurses have been updated on the new guidelines. We ensured that at least one (more often 2) health care professionals in each facility have been updated. We will continue training and support/mentorship of front line health professionals. This will be done with the assistance of the master trainers that we have trained

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(more than 200), including those based at regional training centres as well as those with our development partners. Ordering and distributing FDCs Our central procurement unit (CPU) in the National Department of Health has worked tirelessly with suppliers, provincial medical depots as well as facilities to ensure that depots placed orders with suppliers and health facilities placed orders with depots. We are confident that we have sufficient supplies of ARVs for all patients who are eligible for the FDCs. Given the magnitude of the change we have decided that newly diagnosed patients (that is, those eligible but not yet on ARVs) as well as pregnant HIV positive women will be put on FDCs from the beginning of April. They will get one months supply of FDCs for the first three months. This means that they will have to see their clinician monthly for three months so that they can be carefully monitored. Thereafter, if they are stable they will be given three months supply of FDCs. From June onwards all other stable, non-complicated patients will be switched to FDCs after consultation with their clinicians. As I said when I announced the award of the tender, because we also want all pregnant HIV+ women to be on FDCs, we decided to introduce a pregnancy register at selected sites to conduct surveillance on adverse drug reactions. We are doing this not because we dont trust these drugs but because this is a normal part of clinical practice which is done everywhere in the world. We need to carefully monitor reactions of patients on drugs and take action when we see any systematic adverse events. I must emphasise that this is not because we are anticipating any adverse events but because this is good clinical practice all over the world and is done regardless of the drugs being used. With the assistance of the World Health Organization the first site using this register was initiated last week at Prince Mshiyeni Hospital in eThekweni, KZN. Two other sites will come on stream in the next few months in Gauteng and the Western Cape. Our ability to provide drugs without interruption! We have been working with our three suppliers to ensure that they are able to supply us the requisite quantities without disruption. In order to ensure an uninterrupted supply of antiretroviral medicines on the new tender, the National Department of Health has initiated monthly supplier meetings. At these meetings the forecasted demand for the following 3 months are presented to the manufacturers so that they can plan their manufacturing accordingly. In addition supplier performance indicators are presented and solutions to any difficulties in meeting our demand are resolved. On the demand side, data is collected from Provincial depots on a weekly basis and analyzed in order to identify weaknesses in the supply chain which are then
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addressed either with the Province or the Supplier depending on the nature of the problem. It is anticipated that the transition for stable patients from the current three individual single drugs that they are taking to the fixed dose combination is going to present a particular challenge as the one drug replaces the other three. In order to facilitate this transition a specific monitoring system has been introduced whereby patient and medicines supply statistics are collected at the facility level in order to identify low stock level before they become a problem. To date 389 857 units of the fixed dose combination has been supplied to the Provinces in order to serve the anticipated 180 000 patients who will receive these medicines in the first phase. Most of this stock has been distributed to the facilities and a small buffer stock retained at the depots. In order to replenish stock level orders have been placed with the three suppliers for a further 915 000 units which will be delivered during the course of April. In order to avoid stock shortages there needs to be a buffer stock based on the number of patients and whether they receive a 1 month or a 3 month supply of drugs. The necessary forecasts and calculations have been carried out to ensure that the demand for drugs by patients will not outstrip the supply with resulting stock-outs. Suppliers have presented production plans to increase volumes to 1.5 million units per month by September this year. This is a sufficient quantity to allow all patients, including switching of existing stable patients currently taking three individual antiretroviral drugs, to have access to the single fixed dose combination. If our suppliers are able to increase manufacture of the fixed dosed combination drug before this we will transition patients at an earlier stage. We have data check sheets at each facility which will help the provincial and national Departments to monitor numbers of patients on FDCs to ensure that this policy is being effectively and efficiently being rolled out at each and every facility in South Africa. These data will also monitor the quantities of stock at facility level to ensure that adequate stocks are available at facilities. Benefits of the FDC roll-out We believe that the roll-out of the FDC will assist a great deal in the management and treatment of HIV and the following are the benefits: 1. The fix dose combination will improve compliance and reduce the risk of patients not complying with treatment dosage. 2. The fix dosage will simplify treatment regime thus reduce mistakes in prescribing and allow patients to take one pill once a day

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3. The three drugs in the one pill complements each other and are highly effective in reducing the viral load and thereby improve patients immune response and provide the best chance of reducing the risk if drug resistance 4. The fix dose combination will also improve and simply treatment of TB and HIV co infection and substantially reduce the pill burden. 5. Patients with susceptible TB with HIV co infection will now receive TB drug co formulation together with the ARV fix dose combination. 6. Pregnant women who are HIV positive will now receive same highly effective Triple Therapy ARV in the form of the fix dose combination. 7. This policy change will contribute to our national strategy to eliminate mother to child transmission. 8. Breast feeding mothers will continue having the triple therapy fix dose combination for the duration of breast-feeding thus defending their babies 9. The impact of having highly effective antiretrovirals during the breast feeding period will further reduce the risk of HIV transmission during this period. Finally, in preparing for todays launch and beyond, the National Department has been in touch with facilities to check stock levels daily and we will continue to do this until we are absolutely satisfied that all facilities are able to provide this service consistently!

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