AIDS and the new drug intiatives

AIDS and the new drug Initiatives

Adeze Ojukwu

Saturday, December 6, 2003

News about AIDS is always discomfiting. The reports are even more depressing considering the severe toll on the African continent which, again, is often attributable to poor governance and the monopolistic tendencies of the pharmaceutical industry.

But cheerily, relief may be on the way for millions of AIDS victims with the launching of the new fixed dose combinations of treatment tagged 3 by 5 strategy. At this year’s World AIDS Day 2003, marked last Monday, December 1, the World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS (UNAIDS) released ‘a detailed and concrete plan to reach the 3 by 5 target of providing antiretroviral treatment to three million people living with AIDS in developing countries and those in transition by the end of 2005.’

'This is a vital step towards the ultimate goal of providing universal access to AIDS treatment to all those who need it.’

According to a release the world’s apex health coalition is adding three new generic products for first-line AIDS treatment to its list of medicines meeting WHO standards of quality, safety and efficacy. The products are fixed-dose triple therapy combinations containing the following:

· lamivudine,

· stavudine

· nevirapine.

It was learnt that ‘their introduction in the list of quality medicines will increase choice and competition, thus contributing to make AIDS treatment progressively more affordable.’ This is obviously a welcome development for millions of AIDS patients especially in Africa and other poor regions.

‘The 3 by 5 strategy recommends simplified AIDS treatment regimens so that countries can quickly expand access to antiretroviral medicines,’ said Dr Vladimir Lepakhin, WHO Assistant Director-General for Health Technology and Pharmaceuticals.

‘These new products will help the countries which are hardest-hit by the AIDS epidemic get easy-to-take AIDS medicines to the people who need them most urgently.’

Mr Lepakhin explained that single-pill combinations of antiretrovirals are a major breakthrough for AIDS treatment in poor countries as they improve the reliability and security of supplies, which has so far been one of the major obstacles to access. “From a therapeutic point of view, they reduce the number of pills, are easier to take and promote greater patient compliance. They also ensure that the right dosage of each substance is given to the patient.’

It was gathered that as part of the 3 by 5 strategy, WHO and its partners have set up the AIDS Medicines and Diagnostics Service (AMDS), a new mechanism created to make sure that the supply of safe, effective and affordable medicines of good quality are more easily accessible. The WHO Pre-qualification Project will work with the AMDS to assess the quality, safety and clinical efficacy of HIV medicines distributed in developing and transition countries.

At present, the pre-qualification list contains over 50 single-drug, two-drug, and three-drug combinations, including the three newly qualified products. In assessing products and their manufacturers, In simple terms the Pre-qualification strategy provides a rigorous review process and ongoing quality monitoring. One of the benefits of this initiative is that it limits the entry of substandard and counterfeit medicines into the supply channels.’

In addition, the project helps build local regulatory and production capacity by involving local experts in the evaluations. Pre-qualification also respects intellectual property rights while reflecting the highest public health standards. The project, which partners with UNICEF, UNAIDS, the UN Population Fund (UNFPA) and receives support from the World Bank, has been running for two years. It will keep adding products and suppliers to its list, as and when they are found to meet the set standards the organization stressed.

‘We are involved in a dynamic process,’ explains Jonathan Quick, WHO’s Director of Essential Drugs and Medicines Policy. ‘We expect that the list will grow steadily as more companies take an interest in participating and countries expand their HIV/AIDS programs. The highest attainable standard of health is one of the fundamental rights of every human being, without distinction of race, religion, political belief, economic or social conditions’ Constitution of WHO,’ he added.

With the 3 by 5 target to distribute antiretroviral treatment to 3 million people in 50 poor countries by the end of 2005, WHO, countries, and other partners -- according to officials -- need to train 100,000 health workers, develop health systems, and build infrastructure and standards.

Meanwhile, the newly launched program has an estimated funding gap of US$ 5.5 billion over current commitments.

Nevertheless, UNAIDS Executive Director, Dr Peter Piot expressed optimism that the challenge must be met. ‘We must meet the challenge of expanding access to HIV treatment. This requires overcoming the formidable barrier of creating sufficient operational capacity – a key area where UNAIDS Cosponsor WHO must play a critical role. We have adopted a target of 3 million people on antiretroviral treatment by 2005 – a massive challenge, but one we cannot afford to miss,’ he said.

It is recalled that in 2001, partners within UNAIDS and other organizations along with scientists at WHO calculated that under optimal conditions 3 million people living in developing countries could be provided antiretroviral therapy and access to medical services by the end of 2005.

‘Nevertheless, treatment enrolment in afflicted countries continued to lag. On 22 September 2003, the leaders of UNAIDS, WHO, and the Global Fund to Fight AIDS, Tuberculosis and Malaria joined together to declare the lack of access to antiretroviral drugs to be a global health emergency.’

"Preventing and treating AIDS may be the toughest health assignment the world has ever faced, but it is also the most urgent," said WHO’s Director-General, Jong-wook. The lives of millions of people are at stake, he noted sadly. The statistics and data remain daunting:

· 40 million people around the world are infected with HIV, and AIDS epidemic shows no signs of abating according to UNAIDS.

· Five million people became infected with HIV worldwide and 3 million died this year alone - that's 8,000 people every day.

· WHO estimates that six million people worldwide are in immediate need of AIDS treatment.

· 30 million people have died in two decades. 40 million more people are infected. ·

· In poor countries, 6 million people with HIV/AIDS need immediate ART. Less than 8% get it. ·

· Worst hit is sub-Saharan Africa. With 28.5 million people infected, HIV/AIDS has destroyed communities, health care systems and put a shadow upon the future of entire countries.

But the question is: Why antiretroviral therapy(ART)?· WHO believes ART prolongs lives, making HIV/AIDS a chronic disease, not a death sentence.

Affluent countries have seen a 70% decline in HIV/AIDS deaths. ART will help calm fears and change attitudes towards HIV.
ART, as part of a prevention plan, can significantly reduce HIV transmission. ART, once very costly, is now much more affordable.
ART can reduce overall health care costs and restore quality of life.

The 3 by 5 target is hinged on five critical areas:

· Simplified, standardized tools to deliver antiretroviral therapy,

· A new service to ensure an effective, reliable supply of medicines and diagnostics,

· Rapid identification, dissemination and application of new knowledge and successful strategies,

· Urgent, sustained support for countries, ·

· Global leadership, strong partnership and advocacy, \

The 3 by 5 target is to distribute antiretroviral treatment to 3 million people in 50 poor countries by the end of 2005.· To do so, WHO, countries and other partners need to train 100 000 health workers, develop health systems and build infrastructure and standards. 3 by 5 has an estimated funding gap of US$ 5.5 billion over current commitments.

"Described as the largest AIDS project, the 3 by 5 framework is a plan of action by a broad alliance of nations, institutions, and committed people, including those living with HIV/AIDS,” said Dr. Jack Chow, Assistant Director-General of WHO for HIV/AIDS, Tuberculosis and Malaria. Collaborating Dr. Piot stressed the need "for all concerned to work to reach the 3 by 5 target as rapidly as possible. The lack of HIV treatment is without a doubt a global emergency." His words: "We firmly believe that we stand no chance of halting this epidemic unless we dramatically scale up access to HIV care. Treatment and prevention are the two pillars of a truly effective comprehensive AIDS strategy."

One of the benefits of this initiative is that it limits the entry of substandard and counterfeit medicines into the supply channels. The world no doubt is eagerly looking forward for the successful implementation of this initiative especially in Nigeria and other endemic where political and socio-economic instability tend to mar very lofty projects such as this.

In the USA, 700,000 women are raped or sexually assaulted each year with 14.8 percent of women reporting having been raped before the age of 17.

In a study of nearly 1,200 ninth-grade students in Geneva, Switzerland, 20 percent of girls revealed they had experienced at least one incident of physical sexual abuse.

In Peru, a study of 12 to 16 year-olds giving birth found that 90 percent of them were pregnant from rape, often incest.

A study conducted in Tanzania found that HIV-positive women were over two and half times more likely than HIV-negative women to have experienced violence perpetrated by their partners. Tragically, young women are particularly vulnerable to coerced sex and consequently they are increasingly being infected with HIV/AIDS.

Despite this gloomy picture, the UNIFEM boss said "there is hope," given the success already recorded in a few countries that have complied with international and regional agreements in addition to legal, social and health services available to women today -- which did not exist some 15 years ago in several parts of the world.

Nevertheless, the overwhelming impact of violence against women especially the health implications notably death and disability of victims underscores the overriding urgency to end this social scourge.