Wednesday, October 31, 2012

One HIV Pill a Day: Is supply assured ?

By Esther Nakkazi

The once-a-day pill approved recently for HIV medication may reduce costs and improve compliance to life-prolonging medicines, HIV advocates in Uganda say.

Last month, the US Food and Drug Administration or FDA, approved a new combination pill, Stribild, to treat HIV infection effective for only adults who have never been treated for HIV infection.

One of the biggest problems with HIV treatment in Uganda and sub-Sahara at large is drug adherence, which is deepened by the pill burden on a daily basis.

But even though some anti-retroviral therapy users say they are not worried about the price, Uganda's  drug regulatory body, National Drug Authority (NDA) says unless they are confident about supply, the drug will never be introduced here. 

US based Big Pharma, Gilead Sciences is the only global manufacturer so far. The pill infused with four different drugs costs about $75 per day.

“The innovator might not be able to rapidly produce enough quantities. Yet for ARVs we cannot start patients on any drug without assured continuity or its lifetime availability,” said Gordon Katende Sematiko the Executive Secretary NDA.

For any new drugs to get onto the Ugandan market the Ministry of Health would first develop a policy to introduce them and alert development partners to accept to fund it. There should also be a local applicant to register it.

About 95 percent of all anti-HIV drugs distributed in Uganda are funded by development partners and these cater for only 60 percent of the people who need them. So universal access is still a big issue. 

But while the first reaction for development partners was price and they would probably not pay the bill, some Ugandans with deep pockets feel they could for the sake of adherence and convenience pay the price. 

Stribild is estimated to cost about $75 per day, more than 100 percent increase from the $10 for the cheapest regimen on the market today in East Africa. The AIDS Healthcare Foundation that supports many HIV people around the world, reacted by calling the price ‘shockingly irresponsible and unsustainable.’

“I take two pills at night, one pill in the morning and 1 Septrin everyday. But it is difficult not to miss a dose- so a single dose is very conducive. The chances of missing this will be minimal,” said Flavia Kyomukama the national coordinator Global Coalition of Women against AIDS in Uganda. 

On average, an HIV patient on medication takes at least four pills per day if they do not have any opportunistic infections. If one is infected with tuberculosis the pill number triples.

“Approving the once-a-day pill for HIV is very good news - the cost notwithstanding for now,” said Robert Nakibumba a Community Health Research Consultant.

We know that with advocacy the cost will collapse drastically. In fact, as we push for research into the cure, we want scientists to get a drug with a longer shelf-life like a week if possible, said Nakibumba.

According to a press release from FDA, the safety and effectiveness of Stribild was evaluated in 1,408 adult patients not previously treated for HIV in two double blind clinical trials.

Patients were randomly assigned to receive Stribild or Atripla, an HIV drug that contains two HIV drug compounds- Truvada and Efavirenz, once daily in the first trial. In the second trial the new drug Stribild or the anti-HIV drug Truvada with compounds- Atazanavir and Ritonavir were given once daily.

Results showed between 88 percent and 90 percent of patients treated with Stribild had an undetectable amount of HIV in their blood, compared with 84 percent treated with Atripla and 87 percent treated with Truvada plus atazanavir and ritonavir.

The studies were designed to measure the percentage of patients who had an undetectable amount of HIV in their blood at 48 weeks. “The cost of producing new drugs is exorbitant. Uganda can afford to pay for that pill, it is merely a question of leadership and commitment,” said Kyomukama.


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