Politics and Policy

FDA Approves Johnson & Johnson's Prezista for HIV-Positive People Who Have Never Taken Antiretrovirals

[Oct 23, 2008]

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).

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Drug Access

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

[Oct 23, 2008]

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).

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Science & Medicine

New Vaccine Reduces TB Incidence by 37% Among HIV-Positive People, Study Says

[Oct 23, 2008]

A new tuberculosis vaccine reduced the incidence of the disease by 37% among HIV-positive people during a clinical trial in Tanzania, according to a study presented by lead researcher Ford von Reyn at the 39th Union World Conference on Lung Health in Paris, This Day reports.

For the study, researchers from Dartmouth Medical School and Dar es Salaam's Muhimbili University of Health and Allied Sciences examined the efficacy of a vaccine created from a whole inactivated mycobacterium called M. vaccae, which previously had been tested for safety and immunogenicity during human studies conducted in Europe, North America and Africa. Beginning in 2001, the researchers recruited 2,000 HIV-positive people with an average CD4+ T cell count of 400 to participate in the study. All of the study participants previously received the Bacille-Calmette Guerin TB vaccine, and 70% of the study participants were women. The investigators randomly assigned the participants to receive five immunizations with the active vaccine or a placebo over a period of 12 months. Eighty-five percent of the participants received all doses of the vaccine.

During a three-year follow-up period, the researchers observed 207 cases of active TB and 20 cases of disseminated TB, which occurs when the disease spreads from the lungs to other areas of the body. The researchers also identified 33 cases of confirmed TB among the group receiving the vaccine and 52 cases of confirmed TB among the placebo group, indicating a vaccine efficacy of 37%. Von Reyn said that if 50% of HIV-positive people in Tanzania received the vaccine, TB incidence in the country could decline by about 3,300 new cases annually.

According to von Reyn, the low incidence of disseminated TB can be attributed to the aggressive efforts of trial physicians to diagnose TB before it spread from the lungs. A lack of trial follow-up also could account for the low incidence, as 16% of participants failed to continue the trial, possibly because of sickness. Although the study found no significant reduction in the rates of probable TB, the vaccine appeared to maintain its protective effects for one year when the researchers plotted the event rate in a Kaplan-Meier graph, This Day reports.

According to the study investigators, reducing the TB incidence by 37% demonstrates that the new vaccine provides significant protection against TB, because "anything more than 20% is very favorable in the context of a very common complication of AIDS," von Reyn said. He added that Tanzania's Ministry of Health and Social Welfare is interested in implementing a vaccination program, which would require licensing the vaccine and identifying a manufacturer capable of producing sufficient amounts for large-scale immunizations. According to von Reyn, a remaining challenge for the vaccine will be to examine its effects among HIV-positive people with CD4 counts fewer than 200 (This Day, 10/22).

Kaisernetwork.org is the official webcaster of the Union TB conference. Webcasts of select sessions, interviews and other resources are available online.

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Global Challenges

Human Trafficking Legislation Threatens Cambodia's Progress Against HIV/AIDS

[Oct 23, 2008]

Cambodian legislation against human trafficking and sexual exploitation is posing a threat to the country's progress against HIV/AIDS, IRIN/PlusNews reports. According to Tony Lisle, UNAIDS Cambodia country coordinator, the March 2008 legislation has "had unintentional consequences that have interrupted HIV prevention services in the sex industry." He added that nongovernmental organizations are having "significant" difficulty providing commercial sex workers with HIV/AIDS-related health services because they are leaving brothels to evade police, instead working from the streets and bars.

The country's HIV prevalence in 2005 was 0.9%, a decrease from 1997 when the prevalence was 3.7%. Prime Minister Hun Sen in 2001 endorsed a 100% condom use policy for commercial sex workers that reduced the prevalence among the population from 45.8% in 1998 to 12.7% in 2006. However, the recent human trafficking law has led to the targeting of commercial sex workers by police, Lisle said. "Legislation is a necessary component to stop HIV/AIDS, but now we need to make sure police understand the intent of the law and that the laws criminalize traffickers, not consenting sex workers," he said, adding, "Many women (who) choose this work are not trafficked."

Lisle said that new sexual behaviors in Cambodia also are contributing to the spread of HIV, adding that "HIV has a way of finding new hosts and spreading." A survey conducted by Population Services International between 2005 and 2006 revealed two additional factors: clients of commercial sex workers living in coastal and border provinces are more mobile and therefore more likely to spread the virus, and sex workers in the region often have little experience or formal education and cannot negotiate condom use. IRIN/PlusNews also examined a trend in which Cambodian men have long-term sexual relations with women working in karaoke bars or beer gardens, often without using condoms. Many men say that condom use is not necessary because they are in long-term relationships with the women, according to IRIN/PlusNews (IRIN/PlusNews, 10/21).

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Conference in Canadian Province Focuses on HIV/AIDS Among Native Youth

[Oct 23, 2008]

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).

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Opinion

U.S. Assistance Through Programs Such as PEPFAR, PMI 'Impacting Millions of Lives' Worldwide, Opinion Piece Says

[Oct 23, 2008]

Through the assistance that people worldwide "receive from the U.S. government in partnership with host-country governments and civil society partners, Americans are helping fight poverty and forging a more prosperous future," John Danilovich, CEO of the Millennium Challenge Corporation, writes in a Miami Herald opinion piece. According to Danilovich, President Bush has led a "new vision for international development since he took office in 2001," and Tuesday's White House Summit on International Development "spotlighted the successes and challenges of this visionary approach and explored ways to sustain this new era in international development." He adds that the summit "explored principle-based policies and results-driven programs," including the President's Emergency Plan for AIDS Relief, the President's Malaria Initiative and MCC. These programs -- as well as "other U.S. responses to food security, health and education issues -- are producing historic results and impacting millions of lives," Danilovich writes.

Bush's "new approach to international development also emphasizes the principle of partnership," and U.S. assistance "supports partner countries' own plans for development," Danilovich writes, adding, "To ensure the sustainable impact of our investments, the United States works with governments and local organizations to build partnerships and support effective homegrown solutions to sustain economic development well into the future." According to Danilovich, "Americans share a belief that to whom much is given, much is required. Americans also believe that our help is best used when it goes to those working hard to help themselves." He concludes, "Through these convictions, the United States has delivered unprecedented assistance to individuals and nations taking tough actions to overcome the challenges of poverty. This is a legacy that America can be proud of and must continue to embrace" (Danilovich, Miami Herald, 10/23).

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