HIV-AIDS

 

 

America’s pharmaceutical research companies are testing 109 medicines and vaccines to treat or prevent HIV/AIDS and related conditions, according to a report released by the Pharmaceutical Research and Manufacturers of America (PhRMA).

The report found that of the 109 products in development, 29 are vaccines and 57 are antivirals. These drugs are either in human clinical trials or await approval by the U.S. Food and Drug Administration.

 

Thirty-one medicines to treat HIV/AIDS have been approved since the virus that causes AIDS was first identified more than 20 years ago. The first such medicine was developed in 1987, just four years after the virus was identified. 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. (Click here to see full report.)

 

Despite that progress, AIDS remains a devastating and growing worldwide 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 new people were infected with HIV, and 2 million died from the disease.

 

The U.S. Centers for Disease Control and Prevention estimates that more than 1 million Americans were living with HIV infection at the end of 2006.

From 2000 to 2007, pharmaceutical research 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 building 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 5 million patients nationwide. Since its launch in April 2005, the PPA bus tour has visited all 50 states and more than 2,000 cities.

SELECTED MEDICINES AND VACCINES IN DEVELOPMENT FOR HIV/AIDS*

Engineering Resistant Cells:  An antisense gene therapy in development that targets gene expression and uses two novel technologies to boost immune responsiveness against HIV. One technology involves inserting genetic material into blood cells to slow down the growth of the virus. The second involves inserting new genes into target cells, then integrating the gene into the chromosome of the cell. The cells containing the new genes are then transferred to the patient.

 

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

Changing the Genetics of HIV:  A second 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.

 

Preventive Vaccines:  A gene-based vaccine in development has shown to generate a broad spectrum of immune responses in patients and is designed to protect against the three most common types of HIV-1 virus found in the world.

 

Vaccine HIV Treatment:  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.

 

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.

 

Meeting the Need for Pain Relief:  Painful HIV-associated neuropathy is a frequent neurological complication of HIV/AIDS. It usually occurs in the feet and hands and can be a side effect of the disease and certain HIV medications. A topical medicine in development that is a synthetic form of the naturally-occurring ingredient that makes chili peppers hot, has shown to significantly reduce the pain over several weeks. Currently there are no approved medications for painful HIV-associated neuropathy in the United States.

 

*From Medicines in Development for HIV/AIDS, 2008, PhRMA