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Tuesday, August 08, 2006 

Tuesday, August 8, 2006

Purchase of new drugs against HIV to be seen
By Melissa B. González Valentín
Of PRWOW News

The two treatments recently approved by the Food and Drug Administration (FDA) for HIV patients might not be immediately available in Puerto Rico due to budget reasons, as well as for the need to know more about the advantages they present for the HIV population in Puerto Rico.

This was confirmed to PRWOW News by Dr. León Valiente, chairman of the Pharmacy Committee of OCASET (Central Office for AIDS Issues and Transmissible Illnesses) of the Department of Health and Amparo Yunqué, who also belongs to that committee.

On June 23, the FDA announced the approval of the medicine Prezista—a treatment manufactured in Gurabo—for adult patients whose infection has not responded to treatments with other antiretrovirus drugs.

Besides Prezista, on July 12, the FDA approved Atripla, a pill that contains a fixed combination of three medicines used extensively by HIV patients with the purpose to simplify the number of pills that these patients need to take daily.

Though these medicines could be considered good news in the fight against AIDS, Valiente emphasized that not everything that the FDA approves is appropriate for a determined group of patients. This is why the Pharmacy Committee, which consists of eight members, has the task of meeting every two to three months to evaluate this type of issues. The next meeting is expected to take place at the end of this month, he said.

Yunqué and Valiente agreed on the advantage it could represent for an HIV patient to have to remember to take only one pill a day, instead of three or more as is the case now. However, both presented their concerns on the matter.

For example, Yunqué explained that the purchase of Atripla in Puerto Rico might not be convenient at this time because of the $1.5 million reduction in federal funds for this fiscal year, which totals approximately $21 million.

“If my vote counts, I would not be in agreement. Currently, Sustiva—one of the medicines included in Atripla—is covered by the Health Reform plan. If I, OCASET, would buy this new combination of medicines, I would have to assume the expense of Sustiva, which I currently don’t have to pay,” she explained.

Valiente said his criteria is based more on determining if the clinical state of a particular patient allows them to take Atripla.

“It will depend on the clinical state of the patient and of their laboratories and of their medical history, in other words, of their experience with previous medicines. For example, if the patient cannot use Sustiva—which is one of the medicines within the new medicine—due to a condition he or she has, then the patient can’t use [Atripla],” Valiente explained.

Another contraindication for the use of Atripla could be that it offers a fixed dose of three combined medicines that are currently offered separately to HIV patients in Puerto Rico. The individual supply of these three medicines allows the doctor to adjust the dose of each one in accordance to the need of the patient. With Atripla, this cannot be done.

Regarding Prezista, the medicine manufactured in Puerto Rico, Valiente expressed the need to evaluate it more in detail, since contrary to Atripla, Prezista is a completely new drug and its benefits have still not been studied entirely.

For example, the FDA emphasized that the benefits and risks of Prezista have not been established in regards to children and adults that have never been exposed to any medicine against HIV. In fact, studies are still being conducted on the interaction of the medicine with other drugs, as well as on patients with liver problems, in order to identify what would be the best dose in each particular case.

Yunqué said that if it is determined that Prezista is good for patients that have developed resistance to other current medicines in Puerto Rico, it could be considered since its purchase would substitute the purchase of medicines that currently do not produce effect in these patients.



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