The U.S. Food and Drug Administration (FDA) has approved the manufacture of Norvir (ritonavir) HIV protease inhibitor drug in bottles of 30 capsules. They will continue to be available in bottles of 120. Norvir is not taken as a sole protease inhibitor, but used in small doses to boost the levels of other HIV protease inhibitors.

The FDA in May granted traditional approval to Trizivir, a triple HIV drug combination in one pill. All anti-HIV drugs have come to market based on fast-track approval based on 24-week data. Full approval is contingent upon continued testing out to 48 weeks, with certain requirements. Few of the HIV medications have traditional approval. Trizivir came to market in 2000 with accelerated approval (a designation for meds serving unmet needs). Trizivir is made up of Retrovir (generic name AZT or zidovudine), Epivir (3TC or lamivudine), and Ziagen (abacavir).

The manufacturer of Fortovase (saquinavir) HIV protease inhibitor announced that commercial distribution of the drug will be discontinued by February 15, 2006. Roche Pharmaceuticals will continue to manufacture its original formulation of Fortovase, Invirase (the hard-gel form of saquinavir), in 200 and 500 mg capsules. Ironically, Fortovase was developed to improve saquinavir’s absorption, but it was found that Invirase, when taken with Norvir, has the improved absorption plus a better side effect profile. Invirase has to be taken with Norvir.

Although the product label on the HIV protease inhibitor drug Lexiva (fos-amprenavir) says it should be taken “with caution” with the acid reflux drug Nexium, a study found no effect on the blood concentration levels of Lexiva
when the two medications were taken together. Lexiva manufacturer GlaxoSmithKline conducted the pharmacokinetic study due to concerns that drugs like Nexium, called “proton pump inhibitors,” may lower concentration levels of Lexiva. Acid reflux drugs are commonly taken by people on HIV medications. The results were presented in April at the 6th International Workshop on Clinical Pharmacology of HIV Therapy, in Quebec.

The FDA in March approved the once-daily drug Baraclude (entecavir) for hepatitis B. In a study of 68 persons co-infected with HIV and hep B taking Epivir, Baraclude significantly dropped levels of hepatitis virus. Moreover, 34% of the 51 individuals in the Baraclude group vs. 8% of the placebo (fake drug) group achieved ALT normalization during the first 24 week, placebo-controlled part of the study (at which point everyone received Baraclude, out to 48 weeks). Epivir is an HIV drug that also treats hep B, so its use might lessen the effectiveness of Baraclude, but it didn’t do so.

From George Martinez, TPAN member and HIV transplant advocate: “I want to share with you a bit of information that has rocked my boat. I received a call from an individual who has HIV and liver disease who recently switched local medical providers and will be evaluated at Northwestern Memorial Hospital, where I received my transplant. I am confident that the medical staff at NMH will give him a thorough evaluation and will prepare him for potential surgery. He has great spirits and would like to help this cause with his example once he gets to feeling better.

“His previous primary care physician told him a few months ago that he was not eligible for a liver transplant, because he has HIV/AIDS. This was a clear indication to me that this physician is not aware of what is going on in his own backyard. I know that transplantation in HIV is new in the country, let alone here in Chicago.

“I guess I feel that the need for getting the message out about the NIH Study is very important. I can see for myself, here in Chicago (Rush University Medical Center and University of Chicago are on the multi-site study list, and Northwestern Memorial Hospital will do transplants on people with HIV) that publicity and advertising are critical to helping save lives. I will not let patients be told that they will die when a life-saving option is available.”

The U.S. Government Accountability Office (GAO) criticized the FDA for not changing the labeling on spermicide products containing nonoxynol-9 (N-9). The substance was formerly thought to have protective ability against HIV. Research found the opposite: it irritates the lining of the genitals, making it easier for HIV infection to occur. A GAO report released in April stated that the FDA’s inaction put people at risk for HIV.

Last year, TheBody.com asked more than 600,000 people who visit their website to send in their votes for TheBody.com’s first HIV Leadership Awards program. After months of poring over countless nominations, a distinguished panel of judges selected 73 outstanding professionals and inspiring people with HIV.

“The result, I think, is a snapshot of some of the best in HIV care,” states Bonnie Goldman, Editorial Director of TheBody.com. “Winners of TheBody.com’s HIV Leadership Awards work in a multitude of settings, including prisons, universities, hospitals, clinics, military hospitals and large agencies. Many of our winners have been deeply involved since the epidemic’s earliest years.”

Three individuals from Chicago made the grade, including Bethsheba Johnson of the Luck Care Center; Chad Zawitz, M.D. of Cermak Health Services, who practices at Cook County Jail; and former TPAN staffer and Positively Aware contributor Carlos A. Perez.