The study is recommending that Apotex adjust its Apo-TriAvir pills’ taste and that Rwandan clinics advise patients on how best to swallow them.
The report, conducted by government HIV research agency TRAC Plus, might be released as early as this week, almost a year later than planned.
The millions of Apo-TriAvir drugs first arrived in Rwanda in September two years ago and the bitterness problem came to researchers’ attention last July.
A pilot study in Kigali revealed that five of 25 patients surveyed missed doses of the life-saving medication because they tasted bad. Eight patients said the pills were too bitter, according to Dr. Jean d’Amour Ndahimana at the Care and Treatment Department at TRAC Plus, where the government researches HIV.
The government started a nation-wide survey last August, sending questionnaires to eight of the hundreds of clinics around the country.
The survey was meant to take three weeks, but the results still haven’t been released.
“It was expected in September last year,” said Dr. Ladislas Bizimana, a pharmacist leading the study at TRAC Plus. “But there were other activities.”
Nonetheless, Bizimana says the report is finally finished. It was presented to group of experts and their comments were incorporated.
All that’s left is to present to the new director of HIV research, Dr. Sabin Nsanzimana, who will approve it and forward it to the Ministry of Health, which will act on its recommendations.
Until then the details in the report are unofficial, but the recommendations can be made public.
“We recommend asking the manufacturer to revisit the ingredients that were used, to try to decrease this bitterness. The previous brand names which were used by patients were not as bitter as this product is,” said Dr. Joyce Icyimpaye, another pharmacist working on the study at TRAC Plus.
One previous drug, Duovir-N, combines the same three antiretroviral indredients ingredients as the Apotex drug, named Apo-TriAvir. Doctors wrote the exact same prescription and often wouldn’t know which brand their patients were getting. But the two brands of pill tasted so different that many patients spoke up.
“They were saying, ‘you have changed my regiment,’” said Icyimpaye. The report will clarify that the Apotex pills’ quality is not in question and the only problem is taste. It will also recommend that doctors at HIV treatment clinics counsel patients to take Apotex pills with food to mask the bitterness.
Soon the report’s findings might not make much difference to HIV-positive Rwandans, as the supply of Apotex drugs is likely to disappear. Rwanda’s contract with Apotex for generic drugs ended with last September’s shipment and Apotex, facing piles of legal paperwork, has vowed not to manufacture any more HIV medicine for developing countries until Canada simplifies its law that lets Apotex manufacture drugs without expensive patent fees.
The national drug distributor CAMERWA told RNA last September that Duovir-N could be brought back if the Canadian pills are no longer available.
In total, 15.6 million Apotex pills were shipped to Rwanda, starting in September 2008. That’s enough to treat an estimated 20,000 HIV-positive Rwandans per year for two years, though the government’s distribution method means more or fewer patients may be taking the drugs at any given time.
For the pills that remain, Icyimpaye hopes Rwanda’s doctors will follow her report’s recommendations so their patients won’t stop taking their pills. And even if the Apotex deal won’t be renewed, she believes the report will still be useful for the manufacturer.
“For us, we thought maybe it can be better that they have the feedback, because Rwanda was the first country and only country to have the product,” she said. “So if the product has problems, it’s better that they be aware.”