The U.S. Food and Drug Administration (FDA) approved two new HIV drugs this past summer. Atripla is a combination in one pill of three drugs from two different HIV drug classes (the non-nucleoside Sustiva and the nucleosides Emtriva and Viread, which are also available as a two-in-one combination pill called Truvada). Prezista is an HIV protease inhibitor that must be taken with another HIV drug, Norvir.

Atripla

Atripla is one of the greatest achievements of HIV therapy. Atripla is a complete HIV regimen in one pill. And you only have to take it once a day. Other HIV treatment combinations are once daily, but never before just one pill. In addition, the three drugs in Atripla are all heavy hitters in the world of HIV, potent and tolerable. They are all among the drugs listed in U.S. treatment guidelines as “preferred” for first-time therapy. The achievement also overcame two important barriers: the scientific problem of getting the drugs to combine in the same pill (an earlier formulation failed), and the reluctance of pharmaceutical companies to work together. Here, Bristol-Myers Squibb (Sustiva) and Gilead Sciences (Truvada) did just that. Moreover, the two companies agreed to do what advocates requested—make the drug cost neutral. In this case, that means that the new drug does not cost more than the drugs (Sustiva and Truvada) taken separately (approximately $1,000 a month), despite the greater convenience, single co-pay, and development cost. Kudos to BMS and Gilead for their outstanding work. (One cynical medical provider, however, suggested that the formula had been approved much earlier, but was held up by company lawyers hammering out profit shares.)

While Emtriva and Viread are extremely tolerable drugs, Sustiva has a long list of potential central nervous system and psychiatric side effects, including vivid dreams or nightmares, insomnia, dizziness, and depression. Nevertheless, people have said it’s like taking candy compared to other anti-HIV meds, and those who do experience side effects may see them go away after a few months. Sustiva may also cause people to test positive for marijuana (a confirmatory test is needed), and it cannot be taken by women if there’s a chance of becoming pregnant. Because it is very important to take HIV drugs as directed, to prevent the virus from mutating and thus getting beyond the grasp of medications, treatment advocates want people to remember something simple about the once-a-day Atripla: Take… each… dose.

Prezista

Prezista (formally known as TMC-114) was created to work for people with drug resistance to the HIV protease inhibitors (as stated above, this is when the virus mutates and gets beyond the grasp of one or more medications). The drug has long created excitement for its effectiveness in this hard-to-treat group. In Positively Aware’s 2006 HIV Drug Guide, Dr. Dan Berger, a Prezista-funded researcher, wrote, “The take home message should be that TMC-114 has shown very good safety and tolerance… It has also shown to be highly active against a wide range of resistance mutations or multi-drug resistant strains that was unprecedented, compared to other drugs studied for patients with advanced disease or resistance. Finally, a significant increase in CD4 T-cell counts were also seen in the studies of patients on TMC-114.”

As with other new protease inhibitor drugs on the market, Prezista (generic name darunavir), was studied against other PI combinations. All PIs were boosted with a small dose of Norvir, and Prezista doses must be taken with that drug. The FDA reported that approval was based on two studies, in which 70% of people on Prezista “achieved a virologic response [greater than one log drop in viral load],” compared to 21% of the study participants on the other drug combinations. Forty-five percent had undetectable (less than 50) viral load compared to 12.1% for the other groups, and T-cell increases were 92 vs. 17. Results are from 24 weeks of study, which is still early in research. The most common side effects of Prezista/Norvir were diarrhea, nausea, and headache. In addition, about 7% experienced skin rashes ranging from mild to serious (Prezista is a sulfa drug). In addition to the usual continuing study of drugs brought to market under accelerated approval, Prezista will be studied for pediatric use, drug-drug interactions, and appropriate doses in people with liver impairment. Prezista, discovered and developed by Tibotec Pharmaceuticals, is the first HIV drug to be marketed by Johnson & Johnson.

The AIDS Treatment Activists Coalition (ATAC) applauded Tibotec Pharmaceuticals for not pricing Prezista higher than the two most recently approved HIV protease inhibitor drugs. The group said that the $25 a day cost is $9 less than that of Aptivus and only 25 cents higher than Reyataz. Tibotec originally planned to price the medication at $34 a day, said the group in a press release. ATAC noted that, “The price of prescription drugs has gone up radically over the last ten years. In 1996, when the first highly effective anti-HIV combination therapy became available, treatment for a single individual cost at least $12-15,000 a year per person for a typical 3-drug cocktail. Today, a single drug can cost this much or even twice this amount.”

A study of Aptivus in people taking anti-HIV medication for the first time was stopped due to inferior performance at 60 weeks. An Aptivus combination was being compared to a Kaletra combination. Earlier, at 48 weeks, Aptivus was found to be non-inferior (an FDA-established goal) to Kaletra. Aptivus came to market based on effectiveness seen in people who were heavily treatment-experienced, with drug resistance.

The FDA in June approved EHIV, a test for all known types of HIV: HIV-1, HIV-2, and a subtype of HIV-1. Previously, people with HIV-2 were testing negative in the U.S. because tests only looked for HIV-1, the vast majority of types in the country. HIV-2 is primarily found in West Africa. The company behind the test, Bayer, reported that EHIV is also the first fully automated HIV test, eliminating manual lab work.

In July, the U.S. Department of Health and Human Services (DHHS) updated its perinatal treatment guidelines. A section devoted to drug resistance was added. Care needs to be taken with HIV drugs during pregnancy to avoid limiting future treatment options for both the mother and child (if necessary). To see the guidelines, visit www.AIDSinfo.nih.gov. Call 1-800-HIV-0440 (448-0440) or write AIDSinfo (or “Guidelines”), P.O. Box 6303, Rockville, MD 20849-6303 to request a free copy.

Advocates have long pointed out that condom usage helps lower the risk—but not completely—of the very common sexually transmitted infection HPV (human papilloma virus), which can lead to cancer. The virus can be transmitted from skin-to-skin contact, as from the unprotected testicles. People infected with abstinence madness, however, pushed for stringent wording on condom packages and government Web sites to the effect that really, condoms don’t work against HPV. That’s why a recently published study in the prestigious New England Journal of Medicine (NEJM) gathered so much press attention. The study in the June 22 edition reported that young women engaging in condom-protected sex for each intercourse were 70% less likely to get HPV than women whose partners used condoms less than 5% of the time.

Meantime, the FDA also approved the first vaccine to protect against HPV, Gardasil, for use in girls and women ages 9 to 26, preferably before intercourse has taken place. The abstinence folks are against this too.