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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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The United States Department of Health and Human Services has released an updated version of its “Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.”

The guidelines contain updated recommendations in several areas, including diagnosis of HIV in infants, start of antiretroviral therapy, selection of antiretrovirals, and adherence to antiretroviral therapy in children and teenagers.

The guidelines now also include a rating system to indicate the strength of each recommendation, and formatting changes have been implemented to improve readability. For example, a section on drug side effects in…

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The National Institutes of Health (NIH) released new guidelines last week regarding treatment for pregnant HIV-positive women and prevention of mother-to-child transmission of HIV.

The guidelines include updates on preferred regimens for prevention of HIV transmission during pregnancy.

According to the report, fewer than 200 children are now born with HIV in the United States each year, as a result of efforts to limit mother-to-child transmission.

Transmission of HIV from a pregnant woman to her baby can occur during pregnancy, labor, or while breastfeeding after the baby is born. To…

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The Food and Drug Administration (FDA) last week announced the addition of updated drug interaction information to the prescribing information of all currently approved HIV protease inhibitors.

Protease inhibitors are a class of antiretroviral drugs that prevent HIV from replicating by blocking a necessary protein called protease.

Drugs in this class include Aptivus (tipranavir), Crixivan (indinavir), Invirase (saquinavir mesylate), Kaletra (lopinavir/ritonavir), Lexiva (fosamprenavir), Norvir (ritonavir), Prezista (darunavir), Reyataz (atazanavir), and Viracept (nelfinavir).

Although some of the drug interactions had been known for specific protease inhibitors, the added information…

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Brand Name:	Invirase
Generic Name:	saquinavir mesylate
Company:	Hoffman-La Roche
FDA Clinical Phase:	Approved in 1995 for the treatment of HIV-1 infection

Description

Invirase (saquinavir mesylate) is part of a class of anti-HIV drugs known as Protease Inhibitors (PIs). By inhibiting the action of protease, an enzyme, Invirase ensures that replicated viruses cannot infect other CD4 cells. CD4 cells, also known as T cells, are a special type of white blood…