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FDA Warns Of Potential Harmful Interactions Between Anti-HIV Drugs Invirase And Norvir – The U.S. Food and Drug Administration (FDA) has announced that, when used together, Invirase (saquinavir) and Norvir (ritonavir) can cause potentially life-threatening heart problems. The drugs can lead to conditions known as torsades de pointes, a type of heart arrhythmia, and heart block, which is a problem with the electrical signals in the heart. Symptoms include lightheadedness, dizziness, and abnormal heartbeat. Patients at high risk for these problems include those with preexisting heart conditions, such as abnormal heart rate or abnormal heart rhythms. The FDA encourages patients who are concerned about their antiretroviral regimen to talk to their doctor. Anyone experiencing symptoms can report them to the FDA’s MedWatch program. The FDA has updated the prescribing information for Invirase to include the new warning. For more information, please see the FDA website.

Shionogi-ViiV Healthcare Announces Phase 3 Clinical Trials For New Once-Daily Integrase Inhibitor – Shionogi-ViiV Healthcare has announced the initiation of Phase 3 clinical trials for its new once-daily integrase inhibitor, S/GSK1349572. Integrase inhibitors are a relatively new class of antiretroviral drugs; currently, the only approved integrase inhibitor is Isentress (raltegravir). The Phase 3 trials will include two studies. One will examine the effectiveness of the drug in patients who are treatment experienced but have never received integrase inhibitor-based antiretroviral therapy. The second trial will study the drug’s effectiveness in people who are treatment naïve. Both trials will compare the tolerability, safety, and efficacy of S/GSK1349572 to that of Isentress. For more information, please see the ViiV Healthcare website.

Cytheris Announces Phase 2 Clinical Trial For New Drug Targeting Latent HIV – Cytheris, a small French pharmaceutical company, has announced the initiation of a Phase 2 clinical trial for its new drug CYT107, which targets the latent viral reservoirs in people with HIV. The study will examine the effectiveness of CYT107 in combination with Isentress (raltegravir) and Selzentry (maraviroc). CYT107 is designed to activate HIV-infected cells that are infected with latent HIV – HIV that lies dormant and can start multiplying again if antiretroviral therapy is stopped. The researchers hypothesize that once these cells are activated, the latent virus reservoirs can be reduced or eliminated by administering Isentress and Selzentry. The clinical trial will be conducted in France, Spain, Italy, and the United Kingdom. For more information, please see the Cytheris press release (pdf).

NeurogesX Plans Expansion Of Pain Drug Qutenza To Include HIV-Associated Neuropathy – NeurogesX, a small San Francisco-based pharmaceutical company, has announced plans to apply for an expansion for the use of its drug Qutenza (capsaicin) to include HIV-associated neuropathy. HIV-associated neuropathy is a neurological condition that can be caused by HIV or antiretroviral drugs that damage nerve cells, causing pain, tingling, and numbness. Qutenza is a skin patch currently approved to help with pain from postherpetic neuralgia, a lingering complication of the viral infection shingles. NeurogesX plans to submit a supplemental New Drug Application to the FDA for Qutenza early next year. The application will include clinical data from two recently completed Phase 3 studies examining the effectiveness of Qutenza in patients with HIV-associated neuropathy. For more information, please see the NeurogesX website.

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ViiV Healthcare Expands HIV/AIDS Patient Assistance Program – Starting January 1, 2011, ViiV Healthcare, a collaboration between GlaxoSmithKline and Pfizer, will be expanding its Patient Assistance Program by raising the maximum household income cutoff for enrollment to five times the federal poverty level ($54,150). Additionally, ViiV will be participating in the Welvista program, which provides antiretrovirals to people on AIDS Drug Assistance Program waiting lists. ViiV has also said it will extend its Patient Savings Card program, which provides $100 monthly rebates on its medications, for another two years. It also plans to make the card available in Puerto Rico. The following anti-HIV medications are available through ViiV Healthcare: Combivir (zidovudine/lamivudine), Epivir (lamivudine), Epzicom (abacavir/lamivudine), Lexiva (fosamprenavir), Rescriptor (delavirdine), Selzentry (maraviroc), Trizivir (zidovudine/lamivudine/abacavir), Viracept (nelfinavir), Ziagen (abacavir), and Retrovir (zidovudine). For more information, please see the ViiV Healthcare website.

CDC Releases Updated Statistics On HIV/AIDS Risk By Race And Gender – The U.S. Centers for Disease Control and Prevention (CDC) released new statistics last week that indicate the lifetime risk of contracting HIV is approximately 0.4 percent for Asian-Americans, 0.6 percent for Caucasians, 2 percent for Latinos, and 4.6 percent for African-Americans. On average, men are nearly three times more likely to contract HIV as women. The statistics were calculated from data on rates of HIV diagnosis from 37 states and Puerto Rico. For more information, please see the report on the CDC website.

AIDS.gov Launches “Facing AIDS” For World AIDS Day – To commemorate World AIDS Day on December 1, AIDS.gov is raising awareness through its “Facing AIDS” campaign. Interested individuals are encouraged to download a “Facing AIDS” flier from the website and share why they are facing AIDS. After taking a photo of themselves holding their signs, participants can upload their images to the Facing AIDS Flickr group. To spread the word, all participants are encouraged to share their photos online with family and friends. For more information and additional instructions on how to participate, please see the AIDS.gov website.

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The National Alliance of State and Territorial AIDS Directors (NASTAD) announced last week that the AIDS Drug Assistance Programs Crisis Task Force (ACTF) has negotiated new drug pricing agreements with Gilead Sciences and ViiV Healthcare.

The agreements extend price freezes and provide lower drug prices to struggling AIDS Drug Assistance Programs (ADAPs) nationwide.

Additionally, Gilead has agreed to provide assistance to more people through its own patient assistance program and eliminate certain out-of-pocket expenses for patients with private insurance.

“We remain focused on developing solutions that ensure that individuals living…

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This past Tuesday, GlaxoSmithKline (GSK) and Pfizer launched a joint venture called ViiV Healthcare, a new company dedicated to addressing international HIV/AIDS needs. The company plans to balance drug development and research with patient needs issues, such as accessibility of HIV medication.

The partnership seeks to build upon completed and ongoing research in both companies. By combining forces, GSK and Pfizer hope to effectively share the risks and costs associated with drug research. Additionally, by focusing solely on HIV, they hope to produce the greatest impact for HIV/AIDS patients.

ViiV…