Interview with Prof. Dr. Klaus Leisinger

TB drug donation

The Novartis Foundation for Sustainable Development will play a crucial role in the roll-out and implementation of Novartis’ tuberculosis (TB) drug donation using the DOTS strategy.

In the following interview, the Foundation’s Executive Director Klaus Leisinger describes the added responsibilities Novartis insists on assuming as a “responsible donor” – exploring new ways to ensure high cure rates and overcome obstacles to treatment faced by poor patients.

The lack of healthcare infrastructure – compounded by the devastating effect of the HIV/AIDS epidemic on traditional family structures across sub-Saharan Africa -- makes the challenge even more formidable, Prof. Leisinger says.

How long have you spent putting this project together?

The decision to make the donation was taken two-and-a-half years ago. Making it happen required extensive discussions with both the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) and the World Health Organization (WHO). Most people don’t realize how complicated a program like this can be.

Which countries will be the first recipients?

We want to do Africa first because of the devastating impact of HIV/AIDS on TB prevalence rates. Governments there are very interested in receiving the drug donation – which will release funds from their budgets to deal with multidrug-resistant TB and extend the reach of TB services.

Will this program involve a novel treatment approach?

Novartis will provide special patient kits containing “fixed-dose combination” tablets. Among other compounds, these tablets contain the compound rifampicin, which is the WHO gold standard for TB treatment.

The fixed-dose combination tablets are very patient-friendly and dramatically reduce the number of tablets a patient has to swallow, from 12-14 to 2-3 a day. The combination also prevents development of resistance to any individual drug. The use of rifampicin in the continuation phase of treatment reduces the duration of treatment to six months from eight months. It is also more effective in areas with high HIV/AIDS prevalence.

The drugs will be supplied using DOTS (Directly Observed Short Courses), the internationally-recommended TB control strategy. An important component of this strategy is the use of highly efficacious regimes with direct observation of treatment.

We have some ideas about how to make observation more effective in rural areas – and we will test those ideas in cooperation with the local partners.

Why is a new model for daily observation necessary in sub-Saharan Africa?

Resistance to TB is increasing because standard treatment today lasts eight months and patients need to come to a health facility every day during the first two months to take their drugs under supervision. This imposes a huge burden and cost on patients.

It’s one thing when you live in a city and report to a clinic, take your pills and then go home – though waiting there can also be a problem. In a rural area, it can mean a three-hour walk to the clinic; an hour in a queue before getting the pills; and then another three-hour walk back home. These people are working poor – they can’t afford to do that every day. Often, as soon as they start to feel better, they discontinue their treatment.

The Novartis Foundation, together with the local Health Ministry and WHO, will explore new, more effective methods of observation by giving patients a choice of how they would like their treatment to be supervised – either family-based observation or clinic-based observation.

If they can fit treatment in with the other conflicting demands on their time, it will help ensure their compliance. However areas with high levels of HIV/AIDS infection will pose particular challenges because in many cases the functioning, traditional-family structure has broken down.

We are currently carrying out a pre-study to understand what patient-centered treatment means to patients and local communities – and how best to provide the necessary support nets and services through the general health services. Thereafter we will carry out an intervention study to assess if we achieve higher cure rates with this patient-centered approach.

In the meantime, the Ministry of Health will make DOTS available through the general health services using the traditional model of daily supervised treatment at the health facilities.

Will a country’s health service handle distribution?

Yes the country’s health services will take responsibility for distribution and make the treatment available in their network of health care facilities across the country. As a responsible donor, we also want to make sure that the drugs are easily accessible also to the poorest of patients and to remove any obstacles to patients seeking and staying on treatment.