IAS: Columbia University is coordinating treatment scale at multiple sites in several sub-Saharan African countries

Columbia University is coordinating treatment scale at multiple sites in several sub-Saharan African countries.

Building on the success of its vanguard antiretroviral treatment (ART) initiative, MTCT-Plus, the International Center for AIDS Care and Treatment Programs at Columbia University (ICAP) is now coordinating treatment scale-up at 29 sites in five sub-Saharan African countries.

"Both [programmes] have been able to successfully and rapidly enroll a substantial number of patients into HIV care and treatment programs in a variety of countries and settings in sub-Saharan Africa,” said Denis Nash of the Mailman School of Public Health at Columbia University. He reported on preliminary data from the two programmes at the Third International AIDS Society Conference on HIV Pathogenesis and Treatment in Rio de Janeiro.

ICAP began pioneering care and treatment in the African setting with the MTCT-Plus initiative (see news story). MTCT-plus is an ongoing demonstration project that began in February 2003, in an effort to extend care and treatment first to women enrolled in programmes to prevent mother-to-child transmission (PMTCT), and then to their partners, children and other members of their households.

The Initiative is funded by foundations as well as with US Government support. Currently, there are 14 sites in nine countries: Cameroon, Cote d’Ivoire, Kenya, Mozambique, Rwanda, South Africa, Thailand, Uganda and Zambia. 13 of the sites are in Africa.

On the basis of the lessons learned while providing family-centred care through MTCT-Plus, ICAP secured PEPFAR funding to begin the Multi-Country AIDS Program (MCAP). The programme is currently being run in Kenya, Tanzania, Rwanda, Mozambique and in the Eastern Cape Province of South Africa.

The services offered included prevention of mother-to-child transmission, immunological monitoring, comprehensive family and psychosocial support, HIV prevention, nutritional counselling and support, opportunistic infection treatment and prophylaxis, and ART in accordance with local guidelines.

Enrollment to the programme between September 2004 and March 2005 has been substantial. By March 2005, a total of 23,177 patients were in care at the 29 sites, with 7,979 receiving ART. Accrual to care and treatment had been most rapid at sites in Rwanda and Tanzania, and slowest in the Eastern Cape of South Africa. Patients are being drawn from a variety of referral sources including VCT sites, PMTCT programs, TB clinics, stand-alone clinics, and hospitals.

Forty-three per cent of patients were eligible for ART according to local guidelines, but only 32% were actually receiving antiretrovirals (ARVs) by the end of the follow-up period. The differences in accrual, according to Nash, were due to differences in the characteristics of national treatment programmes and reflect progress at national level rather than PEPFAR progress.

“The proportion of persons who are receiving ART care varies greatly from country to country,” said Nash. Of particular note is the difference in accrual between Tanzania and South Africa; whilst 50% of Tanzanian patients are receiving ARVs, only 10% of South African patients are receiving them.

Perhaps reflecting ICAP’s experience with MTCT-plus, the majority of programme participants are female. Over 60% of the patients receiving ART are women.

The most commonly prescribed regimen among adult patients is d4T/3TC/nevirapine (62%), reflecting the popularity of nevirapine-based ART in resource-limited settings due to its ease of dosing and low cost. The regimen of d4T/3TC/nevirapine is one of those recommended by the World Health Organization as being suitable for first-line treatment in resource-limited settings. Another consideration for a woman with child-bearing potential is that nevirapine is known to be safe to the foetus.

It is interesting to note that PEPFAR funds are not being used in most of these countries to actually purchase treatment. PEPFAR funds can only be used to purchase ARVs that are FDA -approved rather than the generic drugs widely used in the developing world. So in Mozambique, Tanzania, and South Africa, the MCAP is not purchasing drug; while in Rwanda, it is contributing to a basket fund that the Ministry of Health uses to purchase drugs. PEPFAR funds are only being used in Kenya to purchase branded ARVs.

Seven per cent of patients had discontinued treatment by March 2005, of whom 29% were known to be dead. The remainder are lost to follow-up, a classification which, it can be safely assumed, represents death in a large proportion of cases.

Ten per cent of all those treated are children, which is an impressive result. Treating children with ART in resource-limited settings is particularly challenging, giving the complexity of dosing and the expense of the few available antiretroviral formulations for children.

Data on the response to treatment are not yet available from MCAP, but Nash presented data from the MTCT-Plus initiative which has been in place longer than the MCAP program.

According to one analysis of 1,877 patients on ART, for every six months on ART, there was an average CD4 cell count increase of 109 cells, and among 1,338 patients for whom weight measurements were available there was a 2.5 kg increase in body weight. Improvements in CD4 cell counts were also observed among children enrolled in MTCT-plus.

A poster presented at the conference by Dr Elaine Abrams also detailed clinical improvements in 144 children receiving ART through MTCT-Plus. On average, each six months on ART was associated with an increase of 129 cells and a CD4 percentage increase of 3.6%.

However, other findings revealed that there were substantial differences in the magnitude of CD4 response among adults on ART across MTCT-plus sites. In another analysis by Dr Pamela Toro and others, of 1,399 MTCT-Plus patients, each six months on ART was associated with an increase of only 41 cells in CD4 count and a 1.7 kg increase in body weight.

So far, investigators aren’t sure whether the differences are due to innate immunological differences between populations at various sites, or whether they are due to local programme characteristics such as adherence support and provider/patient ratio.

“Analyses from the MTCT-Plus cohort suggest that ART appears to be effective in multiple countries and sites in sub-Saharan Africa, [but] there are site, program, and country-level factors that may be important determinants of program success. These require further study and elucidation if HIV care and treatment programs are to achieve the maximum possible success as these programs continue to scale up around the world,” concluded Nash.

References

Nash, D et al. Expansion of HIV/AIDS care and treatment programs in 5 countries in Sub Saharan Africa. 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment, Rio de Janeiro, abstract MoOa0206, 2005.

El-Sadr W et al. Design and characteristics of HIV care and treatment programs impact on populations enrolled. 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment, Rio de Janeiro, abstract MoPe11.2C40, 2005.

Toro P et al. Response to antiretroviral therapy (ART) in the MTCT-plus initiative, a multi-country HIV care and treatment program in resource-limited countries. 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment, Rio de Janeiro, abstract MoPp0305, 2005.

Abrams E et al. Response to antiretroviral therapy in children enrolled in the Columbia MTCT-Plus Initiative. 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment, Rio de Janeiro, abstract MoPe11.6C28, 2005.