FDA Approves Prezista for Use in Treatment Naive Individuals

FDA on Tuesday approved Johnson & Johnson's protease inhibitor Prezista for use by people who have never taken antiretroviral drugs in the past, the Wall Street Journal reports. FDA in 2006 approved Prezista for HIV-positive people who had developed resistance to other drugs. The agency also granted tentative approval for the drug as part of FDA's accelerated approval mechanism, which allows drugs to be sold while further studies are conducted. J&J obtained full approval for Prezista after submitting studies to FDA through this mechanism (Corbett Dooren, Wall Street Journal, 10/23).

According to J&J, patients beginning HIV treatment should take Prezista -- generically known as darunavir -- in combination with ritonavir. Ritonavir -- sold by Abbott Laboratories under the brand name Norvir -- works in combination with Prezista by slowing down the body's processing of the drug, Reuters reports (Reuters, 10/22). As a protease inhibitor, Prezista works by blocking a protein that HIV requires for replication. Treatment-naive HIV-positive people are recommended to take two 400 mg tablets of Prezista with 100 mg of ritonavir twice daily, and patients who have previously taken other HIV medications are recommended to take 600 mg of Prezista twice daily. J&J will discontinue the production of a 300 mg tablet following a decline in demand. According to the company, the wholesale price of the drug is about $740 monthly.

Glenn Mattes, president of J&J's Tibotec Therapeutics, said FDA approval of Prezista for newly diagnosed HIV-positive people "is a significant expansion of our ability to reach the entire population of patients who should be treated with a protease inhibitor." According to the AP/Boston Globe, during a study that compared Prezista with Kaletra -- a similar drug produced by Abbott -- 84% of patients treated with Prezista had HIV viral loads drop to an undetectable level, compared with 78% of patients taking Kaletra. However, this difference was not considered statistically significant (AP/Boston Globe, 10/22). Side effects of Prezista include diarrhea, headache, nausea, skin rash and, in some cases, hepatitis and liver failure (Reuters, 10/22).

HIV/AIDS Drug Access Problems in Mozambique Cannot Be Solved Solely Through Antiretroviral Plant, Health Official Says

A pharmaceutical plant in Mozambique's capital of Maputo that will produce generic antiretroviral drugs cannot be the sole solution to problems associated with access to treatment, Health Minister Ivo Garrido said recently, AIM/AllAfrica.com reports. According to Garrido, the plant, which is being funded by Brazil, will alleviate the government's financial burden of purchasing the drugs but will not reduce all barriers to treatment.

Garrido said that there "are a number of steps related to procurement" of antiretrovirals, "which are removed when there is a factory in the country," adding that the "plant will ease matters for the government since, rather than having to wait for medicines and go through all the process of clearing them through customs, now the government will just collect them." However, he added that some problems associated with antiretroviral access will remain because most HIV-positive people are not aware of their status and thus do not seek treatment. Garrido said, "It would be nice and easy if the problem was just limited to the availability of" antiretrovirals, adding that if "that was the case, we would simply buy medicines and the problem would be solved." Instead, he said that "the problem is more serious and deep and is related with society. It's false to claim that people don't have access to" antiretrovirals "because the drugs are not available. The main reason is that most people are unaware that they are ill."

According to Garrido, there are no shortages of antiretrovirals in Mozambique, although he added that "eventually this could happen in the future due to the increase in the number of beneficiaries." Instead, he said that low antiretroviral coverage rates are the result of other factors, such as a shortage of medical workers and individuals' lack of knowledge about their HIV status. It is estimated that more than 300,000 people in Mozambique are in need of antiretrovirals, but less than half have access to the drugs (AIM/AllAfrica.com, 10/21).

Urbanization Among Native Youth Can Increase HIV Rates Amongst the Native Population

Aboriginal youth from northern parts of the Canadian province of British Columbia recently gathered for a three-day conference on HIV/AIDS in an effort to curb the spread of the disease in their communities, the CP/Prince George Citizen reports. Conference attendees, ages 15 to 22, were selected by the First Nations chiefs, councils and health directors.

Emma Palmantier, chair of the Northern B.C. Aboriginal HIV/AIDS Task Force, said that youth attending the conference are expected to take knowledge back to their communities. She added the goal of the training is to give young people basic knowledge about HIV/AIDS, in addition to lessons on sexuality and teen pregnancy, lectures, workshops and group discussions. The CP/Citizen reports that at the end of the conference, the attendees will make recommendations to the task force, chiefs and councils, which will then be used to develop community action plans.

Palmantier said that because many youth who move to urban areas like Prince George and Vancouver come from low-income families, they often turn to commercial sex work and drug trafficking as ways to survive. She said, "The governments need to come up with funds to train these youth in trades and jobs so they can live normal lives. There's a big door of opportunity for training" (Trick, CP/Prince George Citizen, 10/21).

For access to ARV's please visit www.aids-drugs-online.com

Jury selection begins in HIV murder trial

The jury selection in the trial of an HIV-positive man charged with first-degree murder in the death of two of his sex partners is scheduled to begin in Hamilton, Ont., on Monday.

Johnson Aziga, 52, is believed to be the first HIV-positive person in Canada to be charged with murder after allegedly having unprotected sex and passing on the deadly virus that causes AIDS.

Two women he allegedly had unprotected sex with died of AIDS-related complications. One of the Toronto women died in December 2003 and the other died in May 2004.

Ugandan-born Aziga is also accused of 13 counts of aggravated sexual assault, which includes 11 other women he allegedly had sex with and with whom he did not disclose he was HIV positive.

The Supreme Court of Canada has ruled one partner cannot give true consent for sexual relations if the other fails to tell partners about an HIV infection.

As a result, the deaths of the two women are considered to have resulted from sexual assaults, which automatically calls for first-degree murder charges that carry an automatic life sentence.

The aggravated sexual assault charges carry a maximum sentence of 14 years in prison.

Aziga's trial has been delayed many times due to adjournments sought by the defence. Aziga has fired three legal teams leading up to the trial.

Aziga's trial now is expected to begin on Oct. 20.