HIV-AIDS

 

 

America’s pharmaceutical research and biotechnology companies are testing 97 medicines and vaccines to treat or prevent HIV/AIDS and related conditions, according to a new report released by the Pharmaceutical Research and Manufacturers of America (PhRMA).

The report found that the 97 products in development include 23 vaccines and 54 antivirals. These drugs are either in human clinical trials or awaiting approval by the U.S. Food and Drug Administration. (Click here to see the full report.)

Thirty-one medicines to treat HIV/AIDS have been approved since scientists first identified the virus that causes AIDS more than 20 years ago. The first HIV/AIDS medicine was approved in 1987, just four years after the virus was identified.

Although the U.S. Centers for Disease Control and Prevention (CDC) estimate that more than 1 million Americans were living with HIV infection at the end of 2006, the increased availability and utilization of newer prescription medicines has helped to reduce the U.S. death rate from AIDS substantially in recent years, according to government statistics. In fact, the CDC estimates that since the introduction of highly active anti-retroviral therapy in 1995, the annual number of deaths in the U.S. due to AIDS has dropped by more than 70 percent.

Despite this progress, AIDS remains a devastating and growing health problem in developing countries, particularly in sub-Saharan Africa, China, India and the Russian Federation. According to the Joint United Nations Programme on HIV/AIDS, in 2007 an estimated 33 million people were living with HIV, 2.7 million were newly infected with HIV, and 2 million people died from the disease.

From 2000 to 2007, America’s pharmaceutical research and biotechnology companies contributed more than $9.2 billion to improve health care in the developing world, according to the International Federation of Pharmaceutical Manufacturers & Associations.

The projects they supported included clinics to treat patients with HIV/AIDS, education and prevention programs, initiatives to prevent mother-to-child transmission of HIV, and donations of medicines for AIDS and related diseases. A number of companies also provide AIDS drugs at reduced prices in many countries. 
 

Help is available to patients in need through the Partnership for Prescription Assistance (PPA), a program sponsored by America’s pharmaceutical research companies. To date, the PPA has helped more than 6 million patients nationwide. Since its launch in April 2005, the PPA bus tour has visited all 50 states and more than 3,000 cities.

SELECTED MEDICINES AND VACCINES IN DEVELOPMENT FOR HIV/AIDS*

Preventive Vaccine – The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that there are 7,500 people worldwide who are newly-infected with HIV every day. Preventing even some of these infections would have a huge impact on the World’s health. A vaccine in development combines two vaccines into one creating a “prime-boost” vaccine. In a prime-boost approach, the one part primes the immune system to attack HIV and the second part strengthens the response. In clinical trials, the combination vaccine cut the risk of being infected with HIV by more than 30 percent.

 

The IFPMA Clinical Trials Portal offers you tools to find Clinical Trials all over the world. Run a search in HIV/AIDS >

Vaccine to Treat HIV – Another vaccine candidate in development is a topical, therapeutic vaccine, administered through a skin patch. The vaccine is comprised of DNA plasmids carrying HIV genes and is designed to stimulate HIV-specific T-cell immune responses that suppress virus replication and destroy and eliminate the HIV-infected cells. The novel mechanism of action makes the vaccine potentially useful for patients with early-stage HIV infection, who are not yet eligible for antiretroviral therapy under current treatment guidelines.

 

Changing the Genetics of HIV – An antisense medicine in development is different than other gene therapies because it uses a genetic delivery vehicle (or vector) derived from HIV-1 itself, removing disease-causing aspects of the virus. The delivery vehicle appears to sustain the expression of genes delivered to the infected cells for a longer period of time – requiring a minimal number of infusions – and may delay the progression of AIDS and restore the patient’s immune system. It appears to bind directly to the HIV RNA and consequently changes the genetics and biology of HIV, including molecular diversity and the ability of the virus to replicate.

 

Blocking a Key Receptor – Studies show that some people are immune to HIV, despite repeated exposure to the virus. Some of these people have a variant of the CCR5 protein that sits on the surface of their cells. To infect a cell, HIV must first bind to the CCR5 receptor. Since it can’t bind to the variant protein, HIV can’t enter the target cells. A next-generation medicine in development uses this knowledge to block HIV by binding to the CCR5 receptor so the virus can’t enter the cell. The medicine has potential to offer more potent and sustained viral suppression in a once-daily dose.

 

Potential New Class of Antiviral – A new class of antiviral medicines being developed are HIV maturation inhibitors. These medicines appear to inhibit viral particles from reaching maturity so they are incapable of infecting other cells. The medicines work by targeting a particular site on the HIV gag protein that plays a role in the last step of viral maturation. In studies the medicines have shown antiviral activity, even against strains that are resistant to currently available anti-HIV treatments.

 

Preventing HIV Transmission – The World Health Organization states that unprotected sex is the predominant mode of HIV transmission. A new topical microbicide would allow women to protect themselves without the use of condoms. The medicine, one in a class of drugs being studied to prevent sexually transmitted diseases, including HIV – has exhibited potential potent antiviral activity following administration.

 

New Approach to Treating Viral Disease – A new monoclonal antibody in development is unique in that it focuses on features found only on infected cells by binding to a basic component of the cell structure that is exposed on the cell surface only when infected with certain viruses or when they are malignant. After binding to the infected cells, the medicine alerts the body’s immune system to attack the infected cells. This makes the infected cell susceptible to the drug treatment, while potentially sparing healthy cells. In addition, the medicine is derived from the human cell and not the virus, which may keep it from being susceptible to drug resistance.

 

*From Medicines in Development for HIV/AIDS, 2009, PhRMA