MSF shows promising results in ARV pilot treating over 700 in Africa and Asia

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Antiretroviral therapy in resource-limited settings is proving to be effective and durable, according to an analysis of Medecins sans Frontieres' (MSF) treatment programmes presented today at the Fourteenth World AIDS Conference in Barcelona.

Jean-Michel Tassie of Epicentre, Paris, presented findings from a six month prospective analysis of 743 patients who have received triple antiretroviral therapy through MSF programmes in Cambodia, Thailand, Malawi, Cameroon, Guatemala and South Africa. It is the largest report to date on the real-life implementation of antiretroviral therapy in resource-poor settings.

Patients were eligible for treatment if they had a CD4 cell count below 200 cells/mm3, or WHO stage 4 clinical disease (the broad equivalent of a clinical AIDS diagnosis in the Northern Hemisphere). Most patients received an AZT/3TC/nevirapine fixed dose combination, and 74% received an NNRTI-containing regimen, although precise breakdown of drugs taken was not available.

Glossary

virological suppression

Halting of the function or replication of a virus. In HIV, optimal viral suppression is measured as the reduction of viral load (HIV RNA) to undetectable levels and is the goal of antiretroviral therapy.

tolerability

Term used to indicate how well a particular drug is tolerated when taken by people at the usual dosage. Good tolerability means that drug side-effects do not cause people to stop using the drug.

CD4 cells

The primary white blood cells of the immune system, which signal to other immune system cells how and when to fight infections. HIV preferentially infects and destroys CD4 cells, which are also known as CD4+ T cells or T helper cells.

equivalence trial

A clinical trial which aims to demonstrate that a new treatment is no better or worse than an existing treatment. While the two drugs may have similar results in terms of virological response, the new drug may have fewer side-effects, be cheaper or have other advantages. 

gastrointestinal (GI) symptoms

Relating to or affecting the gut, stomach or bowel. GI symptoms include diarrhoea, abdominal pain (cramps), constipation, gas in the gastrointestinal tract, nausea, vomiting and GI bleeding. Among several possible causes of GI symptoms are infections and antiretroviral medicines.

 

The median baseline CD4 cell count was 48 cells/mm3 and, given the advanced disease state of the patients who received treatment, 61 deaths were reported in the first month on treatment. Excluding this group of patients, for whom antiretroviral therapy came too late, the probability of survival after six months was 92.9%, and the probability of remaining on treatment at six months was 94%.

The median CD4 cell increase was 104 cells/mm3 among patients with CD4 cell counting available at their clinic (n=200), and of patients who were weighed, the average weight gain was 3kg after six months on treatment (n=228). Of the 118 patients who received treatment at centres where viral load testing was possible, 82% had undetectable viral load (

An analysis of treatment adherence among patients who received treatment in Thailand showed that adherence was excellent, with 94% of patients reporting that they had taken all doses during the preceding week.

Fred Minandi, one of the beneficiaries of the Malawi MSF drug access scheme told the meeting: “To people who say that those in Africa will not be able to take the drugs because they cannot tell the time, I say: my life is attached to these drugs and I can’t forget them.”

An analysis of tolerability of the AZT/3TC/nevirapine regimen among patients who received treatment in Malawi showed that six of 127 had changed treatment due to side effects after six months, and that most of those who experienced side effects did so during the first week or two on treatment, with gastrointestinal problems the most commonly reported problem.

Dr Tito August, an MSF doctor working in Khayelitsha township near Cape Town, South Africa, reported that similar levels of viral suppression and CD4 cell increase had been seen in 177 patients who received antiretroviral treatment through the programme in his clinic. Patients gained a median of 5.5kg and 136 CD4 cells, and 91% had viral load below 200 copies/ml after six months on a triple regimen of AZT/3TC and nevirapine.

Dr August also described how patients were selected for therapy. In addition to meeting the clinical criteria (CD4 cell count below 200 and symptomatic illness), patients were also required to have attended the HIV clinic for at least three months, and to have been on time for four appointments (on time was defined as within seven days of the original appointment).

Patients were assessed by a panel of clinicians, social workers and community members, and the assessment included a home visit and discussion with partner, family and/or support network to determine the level of support they would receive in attending the clinic and taking medication. Patients were also expected to have attended a support group for at least one month prior to starting treatment. Dr August described the community involvement in the assessment process as essential in demonstrating the fairness of selection for treatment. The system also relieves pressure on medical staff to attend to care, which is essential given the level of demand for treatment within the community. It is estimated that around 10% (40,000) of the township’s population are HIV-positive.