News (Updated September 26,
2005)
[Home]
[Previous
news]
Tue Sep 13,10:07 AM ET
Attempts to develop an AIDS vaccine need greater coordination to avoid duplication and increase the chances of success, a senior official of the International AIDS Vaccine Initiative (IAVI) said on Tuesday.
"There is that danger we see right now in AIDS vaccines, a lot of so-called me-too or similar vaccines being tested," Robert Hetch, senior vice-president for public policy of IAVI, USA, told a meeting of the Global Forum for Health Research in Mumbai.
The not-for-profit IAVI, backed by the World Bank, European Union and the Bill & Melinda Gates Foundation, wants a stronger scientific consensus on priorities and a tighter funding system to "avoid this kind of duplication and wasted use of resources."
There are 40 million people infected with HIV around the world and every year 5 million more people are infected and 3 million deaths occur from HIV-related illnesses, Hetch said.
More than 30 vaccine candidates are now in clinical trials around the world, but scientists are not confident that any of them will be really effective in defeating HIV because the virus mutates frequently.
"We estimate that through a series of coordinated and targeted efforts, the timeline could be speeded up by as much as 50 percent," he told the forum in Mumbai, formerly Bombay.
Hetch said the $680 million spent worldwide on AIDS vaccine research and development fell short by several hundreds of millions of dollars.
Anti-retroviral (ARV) drug treatment programs were a long-term cost burden and investing in finding a vaccine was urgent because it could prevent millions of infections and save resources that would otherwise be spent on ARVs, he said.
In 2005 alone, nearly $4 billion was expected to be spent on ARVs in the developing world and it was estimated that this would increase dramatically in coming years, he added.
Tue Sep 20, 9:16 PM ET
The FDA has approved the first generic versions of the AIDS medication AZT, a move that could reduce the expense for people in the United States being treated for the disease.
AZT, an anti-retroviral drug that is also known as Zidovudine, helps prevent the AIDS virus from reproducing in the body. It is often used in combination with other medications to treat an HIV infection.
Generic versions of the drug have previously been unavailable in the United States because patent or market exclusivity restrictions prevented them from being marketed. Now that those patents have expired, versions of drug manufactured by Roxane Laboratories of Columbus, Ohio; Ranbaxy Laboratories of Guragon, India, and Aurobindo Pharma of Hyderabad, India, can go on the market.
The original, sold under the name Retrovir, is manufactured by GlaxoSmithKline. The Food and Drug Administration first approved Retrovir in 1987. A 300-milligram tablet can cost $7.
"These approvals will now allow those infected with HIV more access to these life-saving drugs within our country," said Mike Leavitt, secretary of the Department of Health and Human Services, in a statement.
Thu Sep 22, 2005 5:57 PM ET
NEW YORK (Reuters Health) - Investigators at the Los Angeles County Department
of Health Services recently became aware of four cases of HIV infection related
to work in the adult film industry. The infections occurred despite a widely
adopted voluntary program of HIV and STD testing in the industry.
As reported in the Morbidity and Mortality Weekly Report, the first identified case was a 40-year-old man who tested HIV-negative on February 12 and March 17, 2004, but tested positive on April 9.
Dr. H. Rotblatt, with the Los Angeles Department of Public Health, and colleagues report that, on April 20, the LA County Department of Health Services started an investigation to identify HIV transmission from this case.
During the time between his two negative tests, the patient had engaged in unprotected sex while producing a film in Brazil. After returning to California he engaged in unprotected sex with 13 female partners, three of whom tested HIV-positive in April and May after negative tests results were obtained one month previously.
HIV strains obtained from the four patients and sequenced by the CDC showed that they were all identical, supporting the conclusion that the male patient was the source of the HIV infection.
In September, the California Department of industrial Relations, Division of Occupational Safety and Health, cited employers of the workers for failing to comply with the state's bloodborne disease standard, failing to report a serious work-related illness, and failing to prepare and follow a written occupational injury and illness prevention program.
MMWR editors comment that in Los Angeles County there are approximately 200 production companies employing 1200 workers who engage in direct work-related sexual contact, which is often prolonged and performed without condom use.
"In addition to the testing program being inadequate as the sole source of protection from HIV transmission, the costs of testing are typically borne by the workers themselves," the authors note. "The cost burden of health services could cause some workers to reduce the range and frequency of HIV and STD screening or to avoid or delay pursuing vaccination for hepatitis B virus."
They conclude that "workers in this industry need to be made aware of the risks associated with participation in various acts, to be able to participate in decision-making about their health and safety at work, and to benefit from prevention practices."
SOURCE: Morbidity and Mortality Weekly Report, September 23, 2005.
It did not give financial details, saying it expects to close the transaction before December after regulatory approvals.
This is the third acquisition announced by the Hyderabad-based Matrix in less than a week.
Last Tuesday, it said it had acquired Swizterland's Explora Laboratories, which is engaged in research and development of active pharmaceutical ingredients and intermediates used to make medicines. Financial details were not disclosed.
On Friday, Matrix said it had finalised terms for two joint ventures with South Africa's Aspen Pharmacare to cater to the large demand for AIDS medicines.
Matrix said the Chinese acquisition would help it to consolidate its position as a major supplier of active pharmaceutical ingredients, particularly as a supplier of antiretrovirals worldwide.
"Going by the latest reports on HIV/AIDS infections worldwide, the demand for antiretrovirals is also expected to grow considerably in China over next few years," Matrix said in a statement.
Xiamen-based Mchem group, which had a turnover of about $35 million, makes chemicals, intermediates, active pharmaceutical ingredients and dosage forms, it said.
Matrix shares rose were up 2.7 percent at 187.70 rupees in a firm market. ($1 = 43.9 rupees)
By Ben Hirschler
LONDON, Sept 19 (Reuters) - GlaxoSmithKline Plc has suffered a setback in the race to develop a new kind of AIDS pill, following two cases of serious liver problems in patients taking its experimental drug aplaviroc.
As a result, the world's largest maker of HIV/AIDS drugs has terminated Phase IIb tests of the product on so-called "treatment-naive" patients, who have not received other HIV therapies.
The news was communicated to the HIV patient community in a statement late last week.
Aplaviroc, or GSK 873140, belongs to a new class of oral medicines called CCR5 inhibitors that can block the AIDS virus before it enters human cells.
The discovery of severe liver toxicity is a blow for the drug but does not mean the end of development. Glaxo is offering treatment-experienced patients the option of continuing in a Phase III study, but with additional monitoring for liver toxicity.
A Glaxo spokesman said on Monday the group still hoped aplaviroc, which was licensed from Japan's Ono Pharmaceuticals , would eventually get to market.
PFIZER LEADS RACE
But the setback will handicap Glaxo in its race with Pfizer Inc. , which is already more advanced with its rival CCR inhibitor drug, called maraviroc.
Other companies working in the field include Schering-Plough Corp. .
The news that two out of 250 treatment-naive patients given Glaxo's aplaviroc had liver problems is unexpected, since one of the main advantages of CCR inhibitors was supposed to be their low toxicity.
If successful, scientists believe CCR5 inhibitors could offer hope to patients whose virus has developed resistance to existing antiretroviral medicines.
Industry analysts estimate that a successful CCR5 drug should generate sales of $500-700 million a year, with the first products likely to reach the market in 2007 or 2008.
Most existing HIV drugs work inside the body's immune cells, after the virus has infected. They can cause anaemia, nerve pain, diarrhoea, fat wasting and organ damage -- leading researchers to study other approaches.
Switzerland's Roche Holding AG and U.S. biotech group Trimeris Inc launched the first drug, Fuzeon, to stop HIV from entering healthy immune cells in 2003.
But Fuzeon is expensive, must be injected twice daily and sales, which totalled $135 million in 2004, have been disappointing.
The new drugs from Pfizer and Glaxo can be given as a tablet and work by locking a cellular doorway, or co-receptor, called CCR5.
The idea for the drug class came from the observation that people with mutated CCR5 can resist HIV infection, even after exposure to numerous high-risk sexual partners. Just under 2 percent of Caucasians carry the mutation.
A South African AIDS expert Saturday advocated male circumcision as the best available "vaccine" against the virus in his country, where an estimated 6 million people are infected and more than 600 people die every day.
Francois Venter told a congress of health activists in the Treatment Action Campaign that a recent survey in the Soweto township indicated that circumcised men were 65 percent less likely to contract AIDS than those who had not been circumcised.
"We dream of a vaccine which has this efficacy," said Venter, clinical director of the Reproductive Health and HIV Research at the University of Witwatersrand. "The results are phenomenal."
The association between circumcision and a reduced risk of HIV was noted as early as 1987, when Dr. William Cameron of the University of Manitoba in Canada reported findings from a study in Kenya. Some researchers in early studies have said they believe cells in the foreskin may be particularly susceptible to infection.
Venter urged the Treatment Action Campaign, an influential movement of 13,000 activists, to consider promoting circumcision as a vital prevention tool, given that existing methods were failing to slow the spread of the epidemic.
South Africa has the highest number of people living with HIV/AIDS in the world. Nearly 30 percent of pregnant women are infected, according to a health department survey published in July, and in the hardest hit province of KwaZuluNatal this rises to 41 percent. The disease is now one of the main causes of death among young adults and infants.
Some traditional communities in South Africa practice circumcision, but there are calls for tighter medical controls to limit health risks from blunt and contaminated instruments.
"We don't want our men to go to the chop shop but have medical circumcision," said Zackie Achmat, an AIDS activist who said the congress _ which meets every two years _ would debate whether to encourage mass circumcision.
Achmat, who is HIV positive, said much more needed to be done on prevention. He said that even though government distribution of condoms increased from one million in 1994 to 40 million in 2004, this still only amounted to 35 condoms per sexually active male per year.
He said that 73 percent of young people without the virus believed that they were not at risk of catching, and 62 percent of young people with the virus also believed there was no risk.
Achmat criticized the government's record on treatment. Of the 500,000 people who need AIDS therapy, only 76,000 are currently receiving it through the public health sector. The World Health Organization has singled out slow progress in South Africa as one of the main reasons it will likely miss its target of putting 3 million people worldwide on therapy by the end of this year.
"We are dying. We are still dying," he said.
Achmat has for years attacked the government for doing too little too late against the AIDS epidemic. In a sign of the mutual antagonism, health ministry officials refused invitations to attend the congress.
"President Thabo Mbeki tragically still shows symptoms of AIDS denialism," said Achmat. Mbeki reputedly doubts the link between HIV and AIDS. Health Minister Manto Tshabalala-Msimang has repeatedly voiced doubts about the safety and efficacy of antiretrovirals, instead stressing the benefits of a diet heavy in garlic, lemon and olive oil.
The Soweto study, was conducted by French researchers between 2002 and 2005 with more than 3,000 healthy, sexually active males between 18 and 24. About half the volunteers were circumcised by medical professionals, and the rest remained uncircumcised.
All the men received counseling on AIDS prevention. But after 21 months, 51 members of the uncircumcised group had contracted HIV, the AIDS virus, while only 18 members of the circumcised group had gotten the disease.
The World Health Organization and UNAIDS welcomed the results of the study, released at a conference in Brazil in July, but says that more trials should be conducted before circumcision can be recommended as a preventive method.
A study conducted by the U.S. National Health Institute involving 5,000 individuals is now under way in Uganda.