Cabinet may decide on the plan as early as Wednesday (5 Nov) as the Department of Health finally had all the necessary documents ready late last week.
The plan was due to be tabled at the last Cabinet meeting almost two weeks ago. But some last minute queries from a meeting of the Minister of Health and her provincial MECs (MinMEC) to the task team that drew up the plan delayed the process.
Even if Cabinet approval is immediate ‘ and the plan is so far advanced that it is not likely to face opposition ‘ the drugs are unlikely to reach patients until early next year.
The immediate priority is on preparing health facilities and training for health workers, the vast majority of whom have had absolutely no training in ARV treatment.
While the detail of the operational plan has been a tightly guarded secret, insiders close to the task team say it proposes that each health districts in the country should have a “service point” that will deliver anti-retroviral drugs.
This means that there will be 56 “service points” countrywide to start with. These will be centred on hospitals, but may also include the clinics that the selected hospital serves. Metropolitan areas, which each count as a health district, are likely to be permitted to have more than one service point.
Initially, the task team had proposed that provinces should identify their own sites. However, the Department of Health apparently rejected this idea in favour of the district-based model as it feared a more ad hoc approach might be inequitable.
Government does not want to face another embarrassing court challenge such as the one brought by the Treatment Action Campaign in 2001 that forced it to extend its prevention of mother-to-child HIV transmission programme from 18 pilot sites to all health facilities that requested it.
According to the current proposal, doctors will be in charge of the plan. They will assess patients, prescribe the ARV drugs and check on patients every three months. However, patients will be expected to come to their service centre every month where nurses will check their progress and drug adherence.
“I would support that,” says Professor Robin Wood, who has been piloting ARV treatment in the public sector in Gugulethu in the Western Cape. “A district-based, doctor-driven, nurse monitored plan strikes me as being very reasonable.”
“The plan needs to work within the legal and medical framework. Legally, the drugs have to be prescribed by a doctor not a nurse,” adds Wood, who is associate professor of medicine at the University of Cape Town and currently oversees around 500 patients on ARVs.
Before patients get their drugs, they will be expected to attend three treatment training sessions. These will explain how the drugs work, common side effects and help patients to work out a treatment plan that will ensure that they take the drugs every day at the same time.
Studies show that, unless patients adhere to their treatment plan 95% of the time, the drugs will not work properly. Each patient need to take three different drugs (triple therapy) to ensure that they do not develop drug-resistant HIV.
The Gugulethu project, which has been operational for 15 months, operates in a very similar manner to the blueprint envisaged by the task team plan.
“Over 95% of our 230 patients at Gugulethu are adherent (to their treatment plan),” says Wood. “But the real challenge is to achieve this on a wider scale.”
Under-serviced rural hospitals pose a particularly tough challenge, as Dr Paul Pronyk, is director of Wits University’s Rural AIDS & Development Action Research Programme, based in rural Limpopo knows only too well.
He sees the chronic lack of health resources every day, and says that a “systematic and cautious approach” is necessary to roll out ARVs at hospitals in Limpopo.
“The ARV roll-out is not simply about administering drugs,” says Pronyk. “Hospital laboratories don’t work. Health workers need to be trained. Proper patient registers need to be kept. Patients need counselling. The drug supply must be safe and secure, because there will be a public health disaster if they get into the black market.”
Nevertheless, Pronyk believes that universal access to ARVs is possible ‘ but only if there is “full buy-in” by government, which results in “large scale capacity-building”.
He pragmatically points out that there are massive funds available for the ARV roll-out, both from the South African government and international donors.
No other disease has grabbed the world’s attention as HIV/AIDS has, and foreign donors and governments want to be seen to be assisting those countries in need.
The Clinton Foundation has been working closely with the task team that developed the operational plan. It has offered technical support to South Africa to strengthen its ARV roll-out.
US President George Bush has promised millions of dollars in AIDS aid to South Africa and other affected countries.
“These massive resources can be co-opted to strengthen the healthcare system,” suggests Pronyk. “People don’t die because of lack of drugs in the rural hospitals. A diabetic can die in a rural hospital not because there is no insulin but because there are no batteries for the machine that tests the glucose level. These are management issues.”
One thing that has lightened the government’s load in recent weeks has been the dramatic lowering of ARV prices. Last week (23 Oct) the Clinton Foundation announced that it had brokered a deal with generic manufacturers including the Johannesburg-based company, Aspen Pharmacare, that would reduce the price of triple therapy to around R81 per patient a month for public sector buyers. This is less than half the previous best price available.
The good news with generics is that the three drugs from different companies can be made into one pill, which means patients only have to take two pills a day instead of six.
The TAC has described this huge reduction as “excellent progress”, although it is concerned that some of the generic manufacturers have not been licensed by patent-holders to produce generic versions of their drugs. This means that they could infringe patents if they do produce the drugs.
In addition, the Medicines Control Council has not yet licensed some of the generic ARVs that have been given the go-ahead by patent-holders.
It may take a little while to sort out these complications, but the massive price reductions makes the ARV intervention far more affordable as a life-long treatment option.
But prevention is still the best medicine, and the Department of Health is concerned that the ARV treatment roll-out must go hand-in-hand with prevention.
Recent studies show that after ARV treatment became established in the gay community in San Francisco, which had been hard hit by AIDS, many people became complacent and reverted to risky sexual behaviour.
Wood is also concerned that health workers do not see the drugs as a “miracle cure”.
“There are great expectations, but there is a high complication rate and lots of adverse effects in the first three months when you are treating people with very advanced AIDS. Some 10-20% of very sick patients with CD4 counts of less than 100 develop life-threatening complications and can die.”
While there are no miracle cures, the medical journal The Lancet published a study a few weeks ago that showed ARV treatment could buy patients at least 10 more years of life.
The thought of spending 10 more productive years with the people they love is a powerful message of hope for the 4.5 million South Africans living with HIV/AIDS.
E-mail Kerry Cullinan