Top 10 HIV and Hepatitis Stories of 2009

		SUMMARY: For our last web posting of 2009, HIV and Hepatitis takes a look at some of the top HIV and viral hepatitis stories covered during the past year. Some were major news stories (such as disappointing results from 2 large HIV prevention trials), while others were broader themes running throughout this year's coverage (such as the shift to earlier antiretroviral treatment and an increased emphasis on HIV and aging). The past year also saw a global recession that put international and domestic HIV/AIDS funding at risk, and a debate over health care reform in the U.S. that will have major implications for people with HIV.

By Liz Highleyman

1. New Guidelines Recommend Earlier Treatment
Evidence continued to accumulate over the past year showing the benefits of earlier initiation of antiretroviral therapy (ART), including more complete CD4 cell recovery and prolonged survival. On November 30, the World Health Organization issued new global guidelines calling for treatment initiation at 350 cells/mm3 and use of more tolerable drugs. The following day, the U.S. Department of Health and Human Services also released revised guidelines, raising its ART threshold to 500 cells/mm3 and promoting raltegravir (Isentress) to a preferred first-line option.

2. FDA Approves Raltegravir and Maraviroc for First-line Therapy
The U.S. Food and Drug Administration (FDA) this year approved 2 new drug classes for first-line antiretroviral therapy for treatment-naive HIV patients. The first integrase inhibitor, raltegravir (Isentress) was approved on July 8, and the first CCR5 antagonist maraviroc (Selzentry) got the go ahead on November 20. With the addition of these drugs, patients starting treatment now have a wider array of effective and well-tolerated choices.

3. Two New Pharmaco-enhancers Rival Ritonavir
This year saw the debut of 2 new pharmaco-enhancing agents that may one day be used instead of ritonavir to boost drug levels in the body. Gilead Science's GS 9350 is included in an experimental "quad" coformulation (along with efavirenz, tenofovir, and emtricitabine) that offers a complete antiretroviral regimen in a single once-daily pill. Sequoia Pharmaceuticals' SPI-452 is being studied as a booster for both HIV protease inhibitors and the hepatitis C virus protease inhibitor boceprevir. Neither agent is itself active against HIV.

4. Prevention Trials of HIV Vaccine and Microbicide Prove Disappointing
The field of HIV prevention saw 2 major setbacks in 2009. In September, the U.S. Military HIV Research Program announced that a prime-boost combination of the ALVAC and AIDSVAX vaccines reduced the risk of HIV infection by 31% in a Phase 3 clinical trial in Thailand. Further analysis of the data, however, indicated that the vaccine offered at most a modest protective effect with minimal statistical significance. Adding to the disappointment, researchers revealed in December that the vaginal microbicide gel PRO 2000, which had appeared promising in an earlier trial, was ineffective at preventing HIV infection among women in Africa.

5. Treatment as Prevention Moves to the Fore
In light of recent disappointing vaccine and microbicide data, researchers and advocates are placing increased emphasis on wider use of antiretroviral therapy to lower viral load and thereby reduce the risk of HIV transmission. In the wake of a study suggesting that universal HIV testing and treatment could halt the epidemic within 50 years, the World Health Organization called for universal ART access for HIV positive people as part of a global HIV prevention strategy. More controversial is the prospect of HIV negative people using antiretroviral drugs like tenofovir (Viread) as pre-exposure prophylaxis (PrEP).

6. Growing Awareness of HIV and Aging
A growing body of evidence indicates that ongoing HIV replication wreaks havoc throughout the body well before advanced immune suppression sets it. Some researchers think HIV somehow accelerates the aging process, perhaps by causing persistent immune activation and inflammation. The latest treatment guidelines from the European AIDS Clinical Society (EACS) emphasize management of age-related conditions. HIV and Hepatitis.com offers a comprehensive CME module looking at HIV and aging.

7. Long-awaited Policy Changes on HIV Visitor Ban and Needle Exchange
On October 30, as he signed legislation reauthorizing the Ryan White CARE Act, President Barack Obama announced that the government is lifting its long-standing ban on HIV positive visitors and immigrants; the policy will become effective in early January 2010. In another piece of welcome news for advocates, the U.S. House and Senate ended the year by passing a joint spending bill that eliminates a ban on use of federal funds for needle exchange as part of a strategy to prevent transmission of HIV and viral hepatitis.

8. Oral Hepatitis C Drugs Continue to Show Promise
Given the suboptimal efficacy and side effects of interferon-based therapy for hepatitis C virus (HCV), patients and providers are eagerly awaiting specifically targeted antiviral therapies ("STAT-C") that target different steps of the HCV lifecycle. The 2 furthest advanced HCV protease inhibitors, telaprevir (formerly VX-950) and boceprevir (formerly SCH 503034), continue to demonstrate good safety and efficacy in combination with pegylated interferon. And for the first time, researchers this year presented promising early data from INFORM-1, a trial of an all-oral regimen consisting of the HCV polymerase inhibitor RG7128 plus the HCV protease inhibitor RG7227 (also known as ITMN-191) without interferon or ribavirin.

9. HCV Sexual Transmission among HIV Positive Gay Men
Outbreaks of apparently sexually transmitted acute hepatitis C among HIV positive men who have sex with men, first reported in Europe, are now occurring in U.S. cities. The Centers for Disease Control and Prevention (CDC) recently released a new hepatitis C fact sheet for gay and bisexual men that recognizes sexual transmission as a risk factor. Researchers studying a cohort of New York men who were HIV positive at the time of HCV infection have reported unusually rapid liver fibrosis progression, but good outcomes of early treatment suggest that routine HCV screening for HIV positive men may be beneficial.

10. A New Swine Flu
Finally, many HIV positive people had their eye on a different disease this year, a novel strain of H1N1 influenza A, widely referred to as "swine flu" (though it is actually a hybrid of swine, avian, and human strains). First confirmed in Mexico in April, the flu soon reached pandemic levels. The CDC includes immune-compromised people on its vaccine priority list, though evidence to date does not indicate that people with HIV are at elevated risk of H1N1 complications or death. After months of shortage, H1N1 vaccine is now more widely available, even as the flu pandemic appears to be on the wane; experts warn, however, that the future trajectory of the epidemic is impossible to predict.