What is the real extent of the AIDS epidemic? Why does AIDS attract so much controversy? Do conventional anti HIV drugs do more harm than good? Are there safe and effective treatments that can be made widely available at affordable costs?
This special mini-series is part of an in-depth report, Unravelling AIDS
Sam Burcher reports on an unconventional vaccine that could provide treatment for AIDS
A company based in Thailand has developed an oral vaccine against HIV/AIDS. The makers of a pink pill called "V1"; claim striking success in the treatment of HIV/AIDS symptoms .
Immunitor Corporation Company and V1's creators are clinical researcher Dr Aldar S. Bourinbaiar and pharmacist Vichai Jirathitikal who have put V1 through a placebo-controlled phase II study. The results showed significant improvements in CD4 and CD8 cell counts, weight gain, decreased viral load and survival of end-stage AIDS patients. It also suggested that the V1 could reverse the progression of AIDS without concurrent toxicity .
Immunitor and Dr Orapun Metadilogkul, an independent physician who heads the Thailand Association of Occupational and Environmental Medicine Physicians, claim that 27 patients diagnosed with HIV/AIDS have seroconverted from HIV positive to HIV negative after treatment with V1. A phase III trial application has been submitted to the Thai Food and Drug Administration (FDA) aimed at demonstrating the beneficial properties of V1 on associated symptoms of AIDS such as wasting. If approved, trials will take place at the largest public hospital in Bangkok under Dr Metadilogkul.
V1 is said to be a therapeutic vaccine comprising "HIV antigens from pooled clinical isolates from HIV infected donors". These antigens are made into pills taken orally that do not degrade in the digestion process of the stomach, but trigger immune responses in the underlying mucosa-associated immune cells in the lining of the small intestine.
Some 90% of the immune cells in the human body are made up of lymphocytes and monocytes in the lining of the mucosal surfaces. So there are ten times more CD4 and CD8 lymphocytes residing in the mucosal lining than in the blood where only 2% of lymphocytes are present. According to Immunitor, these intestinal cells are the front-line defence against HIV and are the first to be destroyed or disabled by the virus.
Once mucosal immunity has failed, the common and often fatal symptoms of HIV/AIDS appear, such as diarrhoea and respiratory infections. V1 works on the premise that HIV/AIDS is a disease of mucosal immunity, so targeting antigens at mucosal surfaces is a valid clinical approach.
Public opinion on V1 came sharply into focus when Thai clinics began giving out the pink pills free of charge to AIDS patients at mass rallies organised in schools, police stations, sport stadiums and Buddhist temples. There was opposition to these actions by a number of workers in conventional medical practices, despite the fact that they have no effective treatment to offer to patients with HIV/AIDS.
V1 is extensively subject to toxicity studies both in vitro and in vivo. So far, studies by the Thai government and independent private laboratories have proved it exhibits no toxicity. Five mammalian cell lines tested at the highest dose of 10mg/ml showed no sign of cytotoxicity. The extrapolated dose of V1 that would cause death in humans is 2 200 pills per day, as against the recommended daily dose for adults of one or two pills per day.
Recently published data from Immunitor shows that 40 AIDS patients on a six month trial of V1 treatment increased their CD4 and CD8 cells counts by a mean average of 51 cells (19%) per microlitre of blood. Increase in body weight was 2.2 kg on average. But some patients'weight increased by as much as 30 kg, which is an important gain in the treatment of AIDS.
These encouraging results led Bourinbaiar and Jirathitikal to evaluate V1 therapy in the treatment of terminally ill AIDS patients in intensive care wards in Thai hospitals. They approached 117 patients and 53 decided to take V1 while 64 declined treatment. All patients were bedridden and had been receiving palliative care. None of the patients had access to conventional anti-retroviral drugs, but some had been treated with antibiotics. All the patients in the non-V1 group were dead by week 9. In contrast 30 out of the 53 in the V1 group were alive and able to resume normal activity.
After 20 months on V1, 18% of patients who started with almost zero CD4 counts were still alive. It was also noted that patients receiving V1 seldom developed opportunistic infections, which further suggests that V1 improves mucosal immune responses to infections.
A retrospective analysis by Bourinbaiar and Jirathitikal of 650 HIV positive patients who had taken V1 for an average of twenty-three weeks showed significant results. In total, 496 (76%) were able to increase their body weight or at least maintain weight on the V1 regime; 389 (59%) gained 4.2 kg, while 107 (17%) remained unchanged and 159 (24%) lost weight. Everyone participating in the trial was able remain on it and suffered no serious side effects .
A further study took place whereby V1 was administered to the HIV-negative relatives of terminally ill AIDS patients over a median period of twenty-four days. Their blood was then transfused into the AIDS patients who experienced an improvement in their health. Results showed that increases in CD4 and CD8 counts were statistically significant .
V1 is currently licensed as a food supplement by the Thai Food and Drug Federation (FDA) and is produced for R&D purposes. A one months supply costs around $20-£30 per person, but it is given freely to poor patients in public hospitals wherever possible. So far 65 000 Thais infected with HIV have been given the treatment.
Costs for V1 contrast strikingly with those of more established combination therapies or "cocktails" consisting of three-drug antiretroviral treatments of HIV/AIDS. A recent HIV Cost Services Utilization Study Consortium Analysis estimates that in the USA, 33 500 HIV infected adults seen twice a year for medications and blood tests spend $6.7 billion or $22 000 per patient per year .
Apart from the economic viability of V1, there may be other advantages when considering its use as a safe therapy for the developing world. It has broad-spectrum activity against many HIV subtypes and is stable in ambient tropical temperatures for three years, making refrigeration unnecessary. And no special skills or syringes are needed to administer the pill .
Immunitor is not disclosing the medicinal properties of V1, but instead recommend a cocktail of V1 and certain generic drugs as alternative and inexpensive treatments for HIV/AIDS. They cite examples of five compounds: gramicidin (the first antibiotic to be isolated), cimetidine (Tagamet), warfarin, (a common anti-coagulant), levamisole (an animal de-wormer), originally developed for animal use, but latterly became a useful drug in treating colon cancer in humans, and acetaminophen (Paracetamol). Immunitor says these unapproved drugs are all highly effective against HIV/AIDS and are incredibly cheap in comparison to approved combination therapies . (See Alternative AIDS Therapy from Cheap Generics, this series)
Clinical trials of V1 are ongoing and phase III trials are scheduled for Africa with results pending. It is registered in Ghana and licenses have been applied for in several other African states. Immunitor hopes to build a vaccine plant to supply large amounts of V1 to Africans at low cost. This would meet a critical demand for affordable and available HIV/AIDS treatment in the Continent.
Much attention is centred on the high rates of infection and death, 95%, caused by HIV/AIDS in the developing world. But until recently the intimate association between the pandemic and poverty has been played down in the application of strategic approaches for HIV/AIDS. In his recent letter to The Times newspaper Prof. Kenneth Stuart, the medical advisor to the Commonwealth Secretariat, highlighted the need to recognise the role of poverty in effective treatments for HIV/AIDS. He says "The more the gap widen between rich and poor the greater the number of people who are left stranded in the backwaters of progress." So not only are people in poverty traps deprived access to helpful technologies and medicines their ability to acquire knowledge is diminished along with their human rights .
The report "Thailand Social Monitor: Poverty and Public Policy" says 16 per cent of the country's population, or about 10 million people, are now living on less than the minimal income of Bt900 per person per month, which constitutes the country's poverty line .
"Poverty is re-emerging as one of the nation's most serious problems," said Ian Porter, the World Bank's country director for Thailand at the launch of the new report, which was jointly prepared by the National Economic and Social Development Board, the Thailand Development Research Institute and international experts .An international AIDS conference will be held in Bangkok in July 2004.
Article first published 03/04/04
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