For many years, research on topical microbicides for the prevention of HIV has been overshadowed by the development of drugs to treat the virus and its related opportunistic infections. Topical microbicides are creams or gels with active chemical ingredients that are applied in the vagina to block the transmission of HIV during heterosexual sex. The approval process for chemical substances that prevent HIV has not yet been established.
If one were to compare the HIV-related research presented at the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) to a film, it would not be a sweeping epic. Instead it would be more like a series of short pieces, with some interesting lines of dialogue and bits of memorable scenery thrown in. As the conference is not exclusively devoted to HIV, no single groundbreaking story emerged, but a few presentations did stand out.
In a landmark paper published in Science magazine earlier this year, scientists and policy makers proposed a new strategy to expedite the search for an HIV vaccine. Placing an emphasis on efficiency, the authors of the paper called for all vaccine researchers to coordinate their efforts. This concept is being referred to as the "Enterprise," after the title of the article: "The Need for a Global HIV Vaccine Enterprise."
Several large companies in Africa have drawn praise for providing HIV medications to employees who could not otherwise afford the up to $20,000 per year price tag. The most comprehensive responses have come from large enterprises, notably beverage and mining companies.
In August 2003, South Africa’s largest generic drug manufacturer, Aspen Pharmacare, announced a plan to produce a generic combination of three HIV drugs that will sell for under a dollar a day per person. Aspen launched the first generic antiretroviral drug made in Africa, Aspen-Stavudine, earlier in the month. The drug is produced under an exclusive voluntary license from Bristol-Myers Squibb, which markets stavudine (d4T) as Zerit. With similar licenses from GlaxoSmithKline and Boehringer Ingelheim, Aspen submitted applications to the country’s Medicines Control Council for approval of its generic versions of zidovudine (AZT), lamivudine (3TC), Combivir (AZT/3TC), didanosine (ddI), and nevirapine.
Regardless of the mechanism for antiretroviral procurement, the recent history of TB control efforts offers hope for HIV treatment access. The GDF demonstrates that the availability of drugs can crystallize demand for effective treatment, mobilizing resources and strengthening government commitment. If the GDF can provide treatment for 10 million people by 2005, the goal of antiretroviral access for 3 million starts to look more attainable.
The year of the goat: not quite. According to Roche, 2003 is the “year of Fuzeon.” The first in a new class of AIDS drugs debuted in March and three months later at July’s International AIDS Society conference in Paris, Fuzeon was seemingly everywhere. Each day crowds of conference attendees gathered to hear the intricacies of the new medicine and watch Roche representatives inject Fuzeon into citrus fruits. Few conference sessions failed to mention the drug’s impact on HIV treatment, but so far this attention has not translated into a dramatic surge in Fuzeon sales.
As much of the fanfare at this year’s 2nd IAS Conference on HIV Pathogenesis and Treatment in Paris centered on appearances by Nelson Mandela and Jacques Chirac, a grim certitude was present throughout each plenary, forum and wine-tasting reception: people with HIV still need new drugs.
Each year over 800,000 children are infected with HIV. The source of infection: an HIV-positive parent. In South Africa alone, 100,000 children a year are born to HIV-infected mothers. Nine years after the prevention of mother-to-child transmission (MTCT) of HIV gained research prominence, an alarming number of new infections still occur.
Less than two weeks after the US Food and Drug Administration (FDA) approved a protease inhibitor for the treatment of HIV, another drug won marketing approval. Emtriva, also known as emtricitabine or FTC, was approved July 2 and joins the nucleoside class of existing HIV drugs.
In June 2003, an historic agreement took place in Washington between two odd allies: US President George W. Bush and Brazil’s charismatic, radical former labor leader “Lula,” as Brazil’s President Luiz Ignacio Lula da Silva is called at home. The duo agreed to assist in rolling out a national AIDS treatment program in two Lusophone (Portuguese-speaking) African countries, first in Mozambique, then Angola. The effort will rely on new partnerships among US, Brazilian and Lusophone African groups and institutions.
Analysts were startled when Bristol-Myers Squibb (BMS) announced two years ago that it was acquiring DuPont Pharmaceuticals for $7.8 billion. Rumors circulated among investors that the purchase price was nearly $2 billion more than the next highest bid. It was not clear how Bristol expected to recoup this large an investment. That question looms even larger now: Bristol has abandoned DuPont’s entire stable of promising new HIV drugs one after the other. The takeover’s net result so far has been to increase Bristol’s marketing prowess by enlarging the range of “once daily” HIV drugs Bristol offers while killing off the potential new competition represented by DuPont’s experimental agents.
The second anti-HIV drug to hit the market in 2003 is Bristol-Myers Squibb’s protease inhibitor atazanavir (or Reyataz). It may not be as groundbreaking as the introduction of this year’s first drug, T-20 (Fuzeon). But the drug, which received FDA approval June 20, will continue the trend toward simplified HIV regimens due to its once-daily dosing.
When Severe Acute Respiratory Syndrome, or SARS emerged, scientists were quick to draw on the knowledge and technology developed while working with HIV. Soon after identifying the new human virus, their focus shifted to finding effective drugs to treat SARS. It may be here that HIV research will make the most critical contribution to fighting this new disease.
Homosexual relations in India are largely hidden, and men who have sex with men remain at high risk for HIV infection. A remnant of British colonial law, Section 377 of the Indian Penal Code, bans homosexual behavior. Though rarely applied except when minors are involved, Section 377 and other prohibitions against obscenity and “public nuisance” are a source of blackmail and harassment of men who have sex with men (MSM).
“The first wish of every person is to get that magic pill. But from my point of view, in Russia now, we have more need for psychological support, for jobs, for AIDS prevention – even before treatment,” said Roshupkin. “The doctors and medical professionals concentrate on access to pills. But they have no skills or knowledge about how to work with a person who has to take a pill every day. Support is more important. It can’t be forgotten. That’s why support groups are so important. All of this is just beginning in Russia. It is the beginning of a movement, but we have so much work to do. As activists, we need to show all these young people how to live and stay healthy, not just survive, but how to
carry on with their lives.”
Many view business, and specifically large multinational industries, as a critical ally in the fight against AIDS. But the private sector has been slow to respond to the devastation AIDS is wreaking on developing nations' human and economic health. As the losses become impossible to ignore, corporations in poor countries are beginning to revitalize their efforts to prevent AIDS and make treatments more accessible.
At the age of 12, Laxmi was traveling north from Bangalore in southern India when she was kidnapped from a train platform in Mumbai. Her captors forced her into the city's burgeoning sex trade. Although she is no longer a sex worker herself, Laxmi has become a brothel owner, a peer leader, and a strong voice for safer sex among her "girls." She simply tells them and their clients, "Either you listen to me, or you will die of this disease." The clients' money is collected beforehand, and she has a stock of condoms at her brothel. She gives them out if a client does not have his own. If her supply runs out, Laxmi asks for money. "I tell them, if you don't use condoms, you can have no relations here and send them out," she said.
If it weren't for the spectacular mountain scenery, vaccine researchers gathered at the recent Keystone Symposia in the Canadian Rockies may have come away a little depressed. One after another, the obstacles to finding an effective HIV vaccine were illuminated. These arise from the virus's enormous genetic variation.
Psoriasis has proved to be one of the most dramatic and intractable skin ailments experienced by people with HIV. It commonly appears first on the knees and elbows as itchy or burning inflamed reddish patches that become covered with silvery gray scales or plaque. In more severe cases, the malady can spread to 20% or more of the skin surface and be quite uncomfortable. Psoriasis is not caused by a contagious agent, though skin injury, including that caused by infections, can trigger an episode. Systemic infections as well as certain drugs represent environmental stress factors that can spark psoriasis, too.
This year's Retrovirus conference introduced a surprisingly robust list of HIV vaccine candidates, both still in the lab or already in human trials. Scott Hammer from Columbia University had the daunting task of providing an overview of the many vaccine trials. Beyond the multitude of trials, Hammer's talk zeroed in on a crucial obstacle that current vaccine candidates have yet to counter: viral escape.
AIDS fighters' fondest hope has been that an HIV vaccine will simply and neatly do away with the epidemic, rendering moot all the political and personal barriers to traditional AIDS prevention. They have awaited the results of the first large-scale vaccine efficacy trial with increasing anticipation since the International AIDS Conference last July.
Tenofovir, a recently approved drug for treating established HIV infection, may also be a tool for preventing transmission of the virus in the first place. The drug is marketed by Gilead Sciences of Foster City, California under the brand name Viread.
Structured treatment interruptions — in which patients cycle on and off therapy for days, weeks or months — once again occupied center stage at the 10th Conference on Retroviruses and Opportunistic Infections.
Michel Foucault once said, "There are no relations of power without resistance." Today, the same could be said about the relationship between HIV and the forces that try to suppress it, be they natural immune responses or drug therapy.
Located a half's-hour drive from Havana, the sanatorium at Santiago de las Vegas is the biggest and oldest AIDS center of the 17 on the island. The main facility is hidden behind a walled entrance in an architectural hybrid of heavy Soviet-style institution and Alpine ski resort set in the humid tropics. Across the highway, smatterings of low Florida-style bungalows serve as laboratories and medical wards and house some 450 patients.
"People started calling me the diaphragm lady," remarked Nancy Padian, Director of International Programs at the University of California, San Francisco's AIDS Research Institute. Padian spent much of the last eight years on a spirited quest to study diaphragms' power to prevent HIV transmission. With tens of millions in new funding for trials, she is no longer so easily dismissed.
With the long awaited FDA approval last fall of Hoffmann-La Roche’s products Pegasys and Copegus, Schering-Plough is suddenly facing competition for the hepatitis C market. In January, Roche heightened the rivalry by launching Copegus, its formulation of the standard drug ribavirin, for 43% less than Schering’s price for its ribavirin brand, Rebetrol.
The FDA approved tenofovir (Viread) one year ago for treating HIV as either first-line or salvage therapy. Even as the debate persists over the drug’s best use, tenofovir sales continue to climb. They reached $44.7 million in the second quarter of this year.
How tomatoes grow, what determines a beetle’s eye color, and how to block HIV are very different questions. Yet molecular biologists are now reaching for the same genetic tool to find the answers. Small interfering RNA (siRNA) is a new technology that holds great promise in all these areas. siRNA provides a simple mechanism by which researchers, and perhaps even practicing physicians, can turn genes on and off at will.
Disclaimer: The editors have taken all such care as they consider reasonable in preparing this database, but they cannot be held responsible for any inaccuracies or mis-statements of fact contained herein. Inclusion in this database of any information on any treatment, therapy, or clinical trial in no way represents an endorsement of that treatment, therapy, or trial by ÆGiS or any of its sponsors. This data should always be used in conjunction with professional medical advice.