. GPO-VIR

 

GPO-VIR

     

 

 

 

 

 

 

 

Ministry begins testing GPO-Vir: Anti-retroviral to be used at 400 hospitals -  December 20, 2002

The Public Health Ministry has begun human trials of GPO-Vir, an anti-retroviral cocktail for treating HIV/Aids that was devised by the Government Pharmaceutical Organisation (GPO).

Under a programme jointly supported by the government and the Global Aids Fund, some 13,000 HIV/Aids carriers at 400 hospitals nationwide will have their health monitored after being given  GPO-Vir.

The drug is a combination of the anti-retrovirals Navirapine, Starvudine and Lamivudine, and has been produced by the GPO since April, he said.

If the trials proved successful, the GPO planned to manufacture 15 million tablets per year, at a cost of 20 baht per tablet.

The ministry was hoping to expand distribution of the drug to 800 hospitals over the next two years under a programme to be jointly carried out with the Mental Health Department, which would provide counselling to patients, Dr Charal said.

GPO chief Thongchai Thavichachart said the drug could be given to patients without resistances to drugs for up to seven years, if taken as directed.

Deviations from the recommended dosage could reduce the drug's effectiveness to two years, he said.

Protocol IB 3102/1  Amendment No. 1, Sept. 02, 2002

PROTOCOL IB3102/1 SUMMARY

Title: Studies of Immune-Based Therapy for HIV/AIDS Using HIV-1 Immunogen (REMUNE®) and Antiviral Drugs, GPO-VIR®,in HIV+ Volunteers

Study Objectives: 

1. To determine the safety and efficacy of Thai Government Pharmaceutical Organization (GPO) antiretroviral drugs, GPO-VIR® and HIV-1 Immunogen with GPO-VIR®, on CD4 cell counts, viral load, adverse events, quality of life and cost-benefit of treatment in HIV-infected volunteers.

2. To determine any drug resistance in the subjects in both treatment arms: (1) GPO-VIR® and (2) Remune® + GPO-VIR® Study Design: 1. Open Label Control Study

3. Concerted effort program to evaluate GPO-VIR® treatment only Arm 1) and HIV-1 Immunogen in combination with GPO-VIR® (Arm 2).

Subject Population: 170 HIV-infected subjects with CD4+ cell counts less than 200 cells/ul, categorized into two (2) subgroups, 85 subjects in each subgroup.

Inclusion Criteria: HIV-1 seropositive by ELISA and Western Blot; 15 years of age or older; non-pregnant females, non-alcoholic, no chronic illness nor mental illness. The subject must be able and willing to sign an informed consent.

Exclusion Criteria: Current treatment for malignancy other than basal cell or squamous cell carcinoma of the skin, non-systemic Kaposi's sarcoma or carcinoma in situ of cervix. Alcoholic, drug addict, pregnancy and imprisonment, chronic illness or mental illness.

Study Duration: One year with interim analysis at Week 12 and Week 28.

Collaborating Institutes:

1. Khon Kaen University,Department of Medicine, Khon Kaen University Khon Kaen, Thailand,PI: Dr. Wisut Sukeepaisarncharoen

2. Mahidol University, Bangkok, Thailand,PI: Dr. Vina Churdboonchart,Department of Pathobiology, Faculty of Science,Dr. Worachart Sirawaraporn.Department of Science, Faculty of Science Asst. Prof. Chaweewon Boonshuyar,Department of Biostatistics, Faculty of Public Health

3. Ramathibodi Hospital, Bangkok, Thailand,Virology and Molecular Microbiology Unit,Department of Pathology, Faculty of Medicine,Mahidol University PI: Dr. Wasun Chantratita

4. Vajira Hospital, Bangkok Metropolitan Authority Bangkok, Thailand PI: Dr. Sang-a-roon Kulpradist

5. Songklanagarind Hospital,Songklanagarind University,Songkla, Thailand PI: Dr. Verapol Chandeying

6. Nakornpathom Hospital, Ministry of Public Health,Nakornpathom Province, Thailand PI: Dr. Oraphin Kamsao

7. The Immune Response Corporation, Carlsbad, California, USA, Investigators: Dr. Dennis Carlo and Dr. Ronald B. Moss.́

THAILAND TO LAUNCH DOLLAR-A-DAY ANTI-AIDS COCKTAIL - 22-O3-2002

BANGKOK  - Thai health authorities said Friday they will begin selling the world's cheapest anti-AIDS drug early next month for less than a dollar a day, in a move applauded by activists.

The Government Pharmaceutical Organisation (GPO) is behind the first locally produced anti-retroviral (ARV) "cocktail" which could end up helping hundreds of thousands of HIV sufferers battle the virus which causes AIDS.

The drug, called GPO-VIR, is a single pill combining Stavudine, Lamivudine and Nevirapine, which are known to inhibit the production of HIV in the body.

GPO director Thongchai Thavichachart told AFP his organisation produced a successful initial batch of 120,000 tablets of the drug on March 18 and will first market it at six GPO outlets in early April.

"We will sell it for 20 baht (46 US cents) per tablet, which is very cheap," he said.

The dosage is set at two tablets per day, making the 1,200 baht (27 dollars) monthly cost the cheapest in the world,
Thailand's public health ministry said.

It would also slash Thailand's current lowest monthly cost of 2,500 baht for ARVs by more than half.

The GPO aims to increase production to three million tablets per month over the next six months to meet demand, Thongchai said.

He noted the GPO has successfully prescribed cocktails of the three separate drugs for three years to more than 2,000 AIDS patients.

GPO, Bangkok's Mahidol University and the Department of Medical Science in the health ministry are to submit a proposal for GPO-VIR testing on up to 16,000 HIV-AIDS patients, he said.

International group Medecins Sans Frontieres (Doctors Without Borders - MSF) welcomed GPO-VIR's launch and said it was considering buying the drugs for use internationally.

"We have used GPO drugs on hundreds of patients in Thailand and we have no reason to believe there is any problem with the quality of GPO-VIR," said the Thailand director of MSF-France Yorgos Kapranis.

"Thailand is the only country in Southeast Asia that is producing affordable generic drugs for AIDS patients," he added.

Thai AIDS activists also voiced their approval.

"This launching of the cocktail pill is a benefit on personal and national levels," said Nimit Tien-udom, director of the AIDS Access Foundation.

A previous Thai concoction touted as a "miracle cure" for AIDS, V-1 Immunitor, was distributed last year to thousands of HIV patients in Thailand before it was declared ineffective by the ministry of health.

Distribution of V-1 Immunitor touched off a storm of controversy among AIDS activists and health officials.

Public Health Minister Sudarat Keyuraphan said in a statement the success of GPO-VIR could reduce expenses for some 695,000 Thai HIV-AIDS patients, some of whom have been paying up to 20,000 baht (460 dollars) monthly for drugs.

An estimated one million of Thailand's 60 million people have been infected with HIV, and one third of those have already died.

More than 180,000 Thais contracted HIV last year and some 68,000 developed full-blown AIDS, according to the health ministry's AIDS division.

Thailand's vocal AIDS activists have long pressed the government for anti-retroviral drugs and HIV treatment to be included in a public health care scheme which allows patients to pay just 30 baht per hospital visit.

 

 

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