Kampala lab to monitor HIV drug resistance

In 1991, Naomi Mbabazi was an upper senior secondary student when the blood donating van called at her school in western Uganda.

She and her peers casually decided to donate blood. What began as a gesture to save other people’s lives became a horrendous revelation for the teenager when she discovered she was HIV positive.

“I was shocked. I was still young. But I continued to lead a normal life keeping the results to myself until 2002 when I fell sick,” says Ms Mbabazi, a 36-year old mother of two healthy HIV negative children.

Ms Mbabazi suffered from most of the HIV related opportunistic infections like candidiasis and pulmonary tuberculosis and was admitted in hospital for a long time.

Luckily, she got a slot at the Uganda Joint Clinical Research Institute clinical trial “Development of ART in Africa” (DART 2003-2008).

Her participation enabled her to access free anti-retroviral therapy in October 2003.

Ms Mbabazi’s CD4 count at the beginning was 47 and she was started on first-line highly active antiretroviral therapy drugs — Combivir, Tenofivir and Septrin.

“I was so sick and desperate. When I learnt about a study with free ARVs, I instantly signed up,” says a smiling Ms Mbabazi.

At the time, the drugs cost $150 per month. But in 2009, she had a relapse in spite of the drugs. She discovered she had lipodostrophy — unequal distribution of fats on the body — which is also a sign of drug resistance.

“Colleagues told me, ‘Don’t you see that you are dying.’ I had a buffalo hump, small legs, a very big tummy; I was not born like that,” she recalls.

Medical experts say for the drugs to work properly, adherence to ART is crucial. That is, patients need to take all the pills and stick to a consistent schedule.

But this is not happening as patients tend to veer off the schedule over the long period of taking the drugs.

Coupled with the ease with which the virus can be transmitted, it is a nightmare keeping drug resistance at bay.

“We have put in place measures to ensure adherence is good but you cannot be 100 per cent certain on this. The ART drug resistance problem is in evolution and we need to be prepared to handle it,” said Dr Ivan Mambule Kiggundu at the Infectious Disease Institute (IDI) in Mulago.

In Uganda, there are over 200,000 people on ART, but according to a 2008 study by the Uganda Aids Commission, 71 per cent of the facilities surveyed retained less than 70 per cent of the patients on first line therapy over the first 12 months in spite of increasing accredited sites and drug availability.

To solve the drug resistance problem, the Medical Research Centre/Uganda Virus Research Institute laboratory was commissioned at Entebbe recently.

It will be the regional reference lab to monitor drug resistance for the East African region.

“The lab will enable research on intervention and better care for HIV, monitor drug resistance, diagnosis, measure safety parameters and train more scientists for the region,” Uganda Virus Research Institute assistant director Pontious Kaleebu said.

Research on drug resistance in partnership with Europe Africa Research Network on Second line Therapy (Earnest) has also started at IDI.

The trial will determine the best second line option for resource limited settings in terms of cost, effectiveness and safety.

Patients who fail on first line ART shall randomly be distributed to three groups (arms), each having a combination of drugs, which researchers think are best suited for the second line.

The best group shall determine the best second line therapy and will present reasons why.

Boost to second line therapy

“This information shall be used to inform policy makers in regard to second line therapy which is an emerging subject of great importance and impact now,” said Dr Mambule Kiggundu, the study co-ordinator for the Earnest trial.

After Ms Mbabazi discovered she suffered from lipodostrophy, she presented her case to her doctor who had insisted that since she was “not sick and not about to die,” she remains on the first line combination drugs.

But a new doctor changed her regimen to another combination — Tenovifir, Nevirapine and Epivir which are still first line drugs but of a different combination.

“Look at me,” she demonstrates standing up “I am now a bit more proportional, the lipodostrophy is not progressing and my nails are not black anymore.”

“The Medical Research Centre/Uganda Virus Research Institute unit in Uganda is an example of what can be achieved through collaborative working, taking medical research right through from the lab to the patients’ bedside, improving the health and life span of millions,” said Heiner Grosskurth, the director of the unit.