HIV Medications of the Future

Jennifer Devinney, RPh, HIV Clinical Pharmacist

Over the past decade, research in the area of HIV therapies has greatly expanded. In 1996, Crixivan® (indinavir) became the medication to be granted the fastest FDA approval. A rigorous FDA approval process, which normally takes years, was shortened to only 42 days. In the past month, Kaletra™ (lopinavir/ritonavir) was approved by the FDA, increasing the number of antiretroviral therapeutic options to 16. As we begin the new millennium, there are many HIV therapies currently undergoing various phases of investigation. It is impossible to determine exactly when new medications will be approved for widespread use. However, it is important to keep abreast of the types of agents under investigation in order to maintain active participation in your health care.

Understanding and sharing information about your condition will enable you and your healthcare provider to select the best possible therapeutic regimen for you. For instance, if you have experienced problems with your drug therapy in the past, such as resistance or difficulty tolerating agents because of side effects, one of the new medications may offer you a more favorable alternative.

Before discussing the medications currently under investigation, lets review the different phases of the drug approval process and the type of information being examined through each of these phases.

The 6 Steps to Bring a New Drug to the Market

1. Clinical trials begin with preclinical drug evaluations in the laboratory using test tubes and animal specimens.

2. After the new drug has met both potential effectiveness and toxicity requirements, an Investigational New Drug (IND) application is filed with the FDA. The IND application grants a company permission to begin testing the new medication in humans.

3. Phase I clinical trials involve the use of the drug in healthy individuals to determine safety and dosing ranges.

4. Phase II trials examine the effectiveness of the new agent in patients with the condition that the drug is aimed to treat.

5. The final phase of investigation prior to FDA approval are the Phase III clinical trials, which focus on long-term effectiveness, safety, and adverse effects in large numbers of patients.

6. After the three phases of clinical trials have been completed, a New Drug Application (NDA) is submitted to the FDA for approval to market the new medication.

The entire investigation process can take as long as ten years, but many of the investigational antiretroviral agents are being marketed through an accelerated process. Testing continues even after the drug has been approved for marketing to ensure optimal safety and efficacy.

Patients who have used up all of their treatment options with available antiretroviral medications may be eligible to receive investigational medications through special programs known as Expanded Access, Compassionate Use, and Treatment IND programs. Some programs will only accept calls from physicians, so you may need to contact your doctor in order to get information about these programs.