News (Updated April 8, 2007)
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By Will DunhamWed Apr 4, 7:17 PM ET
The new AIDS drug Prezista performed very well in halting the onslaught of the human immunodeficiency virus in people with advanced infection, a study published on Wednesday showed.
The success of the drug, made by the Johnson & Johnson unit Tibotec Pharmaceuticals Ltd., comes at a time of acute need for new AIDS therapies because many existing drugs are failing as HIV mutates to thwart them.
It is in a class of drugs called protease inhibitors that are designed suppress HIV and prevent it from replicating. The researchers said Prezista, also called darunavir, expands treatment options for patients who do not improve with other treatment.
It is given along with a low dose of an older protease inhibitor called ritonavir.
Prezista won approval from the U.S. Food and Drug Administration last year, marking Johnson & Johnson's initial foray into the $1.5 billion U.S. market for protease inhibitors. It received conditional marketing approval in the European Union for all 27 member states last month.
The researchers tracked 110 people given Prezista in combination with ritonavir and 120 people getting other protease inhibitors for about 11 months.
Forty-five percent of those getting Prezista experienced a drop in their viral load -- the concentration of HIV in their blood -- to undetectable levels, compared to 10 percent of those getting other drugs, the researchers said.
HIV ravages the body's immune system by attacking certain protective white blood cells. Patients getting Prezista had an increase in the number of these cells five times higher than the other patients, the study found.
About 40 million people are infected with the incurable AIDS virus worldwide.
'VERY IMPRESSIVE'
Researchers led by Dr. Bonaventura Clotet of the Hospital Universitari Germans Trias i Pujol in Barcelona, Spain, reported the results in the Lancet medical journal.
"Its potency has been something that has been very unexpected and very impressive," Clotet said in a telephone interview.
"We were very excited by the findings of quite dramatic suppression in viral load in patients," Clotet added.
While many AIDS drugs are available, experts say an alarming number of patients are becoming resistant to them because the virus can mutate quickly -- particularly if patients fail to meticulously follow their drug regimens -- rendering some drugs ineffective.
Dr. Rodger MacArthur of Wayne State University in Detroit, Michigan, who wrote a Lancet commentary on the findings, said doctors treating AIDS patients will welcome the findings. He said patients have been given the drug at Detroit Medical Center.
"The patients who have gone on it have done remarkably well. It seems to be very safe. It seems very well tolerated," MacArthur said in a telephone interview.
"There really is nothing else in this class that is in development, or at least not that is close to entering clinical trials. So this is likely to be the last (new) protease inhibitor that we see for three to five years," MacArthur added.
India is a vital source of cheap generic medicines and campaign groups are worried that the poor in the developing world could lose access to vital drugs if the Novartis challenge succeeds.
The giant Swiss drugmaker has argued that tightening of intellectual property laws would boost investment in developing more medicines, and says that the Indian patent system stifles innovation.
The Madras high court on Wednesday did not fix a date when it would hand down its ruling on the Novartis challenge.
Madras is the old name of the city of Chennai where the closely watched case is being fought.
The affair has become a test-case in a long-running war between "big pharma" and humanitarian campaigners who say drug makers are putting patents ahead of poor patients.
The two-judge court also ordered that another challenge by Novartis to a January decision that rejected its patent application for cancer drug, Glivec, be referred to an appellate board, consisting of experts and headed by a former judge.
"We do not want to express any opinion," the bench said on the Glivec case.
Last month, Novartis chief executive Daniel Vasella said the company did not seek "popularity awards" and would continue with its legal action over the Indian patent system to "serve our patients and remain competitive".
In sub-Saharan Africa, home to two thirds of the world's HIV-positive people, the concern is more acute, as some fear the case -- if it goes in favour of Novartis -- could undermine India's role as a source of cheap generic medicines, especially AIDS drugs.
Humanitarian agency Medecins Sans Frontieres has said tens of thousands of people being treated for AIDS will suffer if the Swiss company succeeds in changing India's patent law.
By CELEAN JACOBSON, Associated Press WriterSat Apr 7, 9:14 PM ET
The extent of the deadly new strain of tuberculosis in South Africa and the region is not known and is cause for concern, an international health expert said Wednesday.
Dr Fabio Scano, a TB expert from the World Health Organization in Geneva, has been sent to South Africa at the request of the government to assist with the outbreak of the extensively drug-resistant tuberculosis strain, or XDR-TB.
"We don't know the extent of multiple drug resistant and extreme drug resistant TB in sub-Saharan Africa and the southern African region. There is not yet the capacity to test in these countries," Scano said at a news conference.
South Africa has reported 352 cases of the virulent strain since it was discovered last year in the eastern KwaZulu-Natal province. There have been 221 deaths and concerns have been raised about the strain spreading across the region.
Scano said an epidemiological investigation was under way to determine the full extent of the disease.
"I don't think the situation in KwaZulu-Natal is unique," said Professor Ronnie Green-Thompson, special adviser to the health minister. "If we test in other provinces we may well find a similar prevalence."
Multiple drug resistant TB, known as MDR-TB, does not respond to a "first line" of drugs while the extreme strain does not respond to a "second line" of drugs.
Africa is the only continent where TB rates are increasing and the disease is complicated by high rates of HIV infection, which lowers a person's immune system.
"MDR-TB and XDR-TB and the way they are magnified by HIV infection is the biggest public health challenge both nationally and internationally," Scano said.
He said that without the drug resistant strain, 12-14 percent of TB patients who have HIV die because of the "lethal combination" of the two diseases.
Scano said WHO was committed to working with South Africa to address the challenge presented by the disease.
"There are a lot of interventions under way but we have yet to see the results ... the fight against TB is a marathon, not a sprint. But there is a need for action now," he said.
Drug resistance grows when people do not complete a grueling six month regime of medication, and South Africa has a low adherence rate.
Part of the two-year collaboration between WHO and South Africa is to ensure greater adherence of patients to the treatment programs.
The health department has had to force a number of XDR-TB patients back to hospital after they tried to return to their homes and in the United States, a 27-year-old man suffering from the extreme strain has been locked up indefinitely as a danger to the public.
Nthari Matsau, Deputy Director-General of the health department, stressed that while it was important to separate TB patients, issues of discrimination and human rights had to be considered.
"Incarceration is not an ideal way of separating TB patients. There are much more acceptable and humane ways," she said.
Scano said new drugs to treat XDR-TB were now available in South Africa but he said there was a huge need for new medicines to be developed to combat the disease.
"Unless there is massive investment in new drugs, we won't make headway in the fight against TB. We have to do the best we can with what we have," he said.
Monday April 2, 2:40 pm ET
The vaccine, which is meant to protect against hepatitis A and hepatitis B, was approved to be given at 7 days, and 21 to 30 days after the initial shot followed by a booster shot at 12 months. Originally, the vaccine was approved in 2001 by the FDA at a dosing schedule of 1 month and 6 months after the initial shot.
The accelerated dosing schedule could benefit people who are preparing to go to such high-risk areas for hepatitis such as Africa, Asia, South America and parts of the Caribbean, the company said. The new dosing could also help emergency responders going to disaster areas overseas, and those who are at a high risk for the disease, such as people with sexually transmitted diseases or who are HIV positive.