by Enid Vázquez

• Intelence safety update
• New once-a-day regimen in the works
• New naïve study
• Gardasil still available
• Gardasil for boys and men
• Circumcision doesn’t help gay men—for now
• CDC factsheet on HIV therapy and transmission
• BROTHERS, a national black male study
• New online program for the post-incarcerated
• OI guidelines for exposed and infected children updated
  
• AIDS Activists Issue Grades to Drug Companies
  

Intelence safety update

In August, Tibotec Therapeutics, with the U.S. Food and Drug Administration (FDA), issued a Dear Healthcare Professional letter regarding Intelence (etravirine). It includes an important safety update regarding severe skin and hypersensitivity reactions.

The warning on the drug label has been strengthened to include reports of hypersensitivity reactions, which sometimes occur with hepatic (liver) failure, and fatality due to toxic epidermal necrolysis (TEN), which is a life-threatening skin disorder that usually results from medication use.

Rash is associated with the HIV non-nucleoside class of drugs, including Intelence, Sustiva, and Viramune. Severe skin reactions, such as TEN, can be dangerous and even fatal. The hypersensitivity (allergic reaction) seen with Intelence has rash as one of its symptoms. The rash is usually seen within the first six weeks of treatment. Remember, however, that allergic reactions can occur at any time.

According to the letter, “Discontinue Intelence immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise [not feeling well, as with a flu], fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema [water accumulation], hepatitis, and eosinophilia [increased levels of the white blood cell eosinophil, usually a sign of an allergic reaction]).” In addition, the levels of liver transaminases should be monitored.

The letter also noted that, “Overall, the cases referenced above, within clinical and post-marketing experience, illustrate the importance of clinical vigilance and familiarity with the signs and symptoms of severe skin rash and hypersensitivity reactions. Additionally, they also underscore the importance of immediate discontinuation of Intelence in cases where severe rash or hypersensitivity reaction is suspected [emphasis in the original].”

View the letter at www.TibotecTherapeutics.com.

New once-a-day regimen in the works

Since its approval in 2006, Atripla has become a top-selling HIV drug in the U.S., which makes sense because it’s a full regimen (“cocktail”) in one pill, taken only once a day. Now another full regimen in one pill is on its way.

In July, Gilead Sciences and Tibotec Pharmaceuticals announced a “license and collaboration agreement” to combine HIV medications from the two companies. The best-selling Truvada from Gilead would be combined with Tibotec’s TMC278 (rilpivirine), a medication that’s still in clinical study. The new one-pill regimen could hit the market within two years. In the past, powerful HIV drug combinations consisted of roughly a dozen pills taken twice a day.

Truvada already has a track record here, since it’s combined with Sustiva, from Bristol-Myers Squibb, to create the super-successful Atripla. Like Sustiva, TMC278 is from the non-nucleoside analog class of HIV medication. Truvada is itself a combination drug, consisting of two HIV nucleoside analog medications, Viread and Emtriva. Atripla raised the bar for HIV therapy in one more way; at the time, cooperation between pharmaceutical companies was very rare.

HIV regimens generally consist of at least three medications from at least two different drug classes. Combining medications helps increase adherence (taking treatment correctly) and lower the cost of co-pays for the patient.

New naïve study

People with HIV who have never taken antiviral medicine—also referred to as “treatment-naïve”—are eligible for a new national study. The Adult AIDS Clinical Trials Group (AACTG) is enrolling treatment-naïve people for a large study comparing three popular HIV regimens currently on the market. For years now, due to the success of antiviral treatment, HIV studies have had the luxury of looking at drugs that are already on the market. Instead of an experimental drug, standard-of-care treatment is provided and studied. This research aims to get a better understanding of when and how to best use HIV therapy, and to compare the regimens to each other in pursuit of this knowledge.

This study, A5257, will compare three popular HIV drugs: Isentress, boosted Reyataz, and boosted Prezista. (“Boosted” means given with a small dose of another HIV drug, Norvir.) The three medications will be given with a backbone of Truvada. (See the Positively Aware Annual HIV Drug Guide, March/April 2009, for more information on these medications.) Individuals must have a viral load greater than 1,000 and no major drug-resistance mutations. The study will screen for this. In Chicago, the study takes place at Rush University Medical Center. Contact study coordinator Valerie Neuhauser, RN, for information at (312) 942-7761 or e-mail her at Valerie_Neuhauser@rush.edu.

Gardasil still available

Also at Rush, Gardasil is still available at no charge to HIV-positive women through research study A5240. E-mail Joan_A_Swiatek@Rush.edu or call (312) 942-6017 for eligibility and enrollment information. The vaccine against the very common sexually transmitted infection HPV (human papilloma virus) is currently FDA-approved for girls and young women ages 13 to 24, but it has been shown to be effective in women up to age 45. That research, however, did not include HIV-positive women, a group at greater risk of HPV complications, including cervical cancer (cancer of the lower end of the uterus or womb).

Gardasil for boys and men

In September, an advisory panel for the FDA recommended the approval of Gardasil for boys and men, ages 9 to 26, primarily to prevent genital warts, which are caused by HPV. Left untreated, warts can lead to cancer. Because gay men, HIV-positive or negative, have higher than average rates of anal cancer, health advocates have been interested in Gardasil’s potential for helping men. The FDA usually approves recommendations made by its advisory panels.

Circumcision doesn’t help gay men—for now

Circumcision might help straight men from becoming infected with HIV, but a new report says it wasn’t helpful for gay guys. Still, the report adds that further findings might change that one day.

Previously, clinical studies in African countries found substantial decreases in HIV infection—as much as 65%—in circumcised men having sex with HIV-positive women. In the new report, CDC researchers looked at data collected for a VaxGen HIV vaccine study during 1998—2002. Because of the previous reports from Africa, researchers looked to see whether circumcision had an impact on the men who became infected during the time they participated in the vaccine study.

The researchers reported that having a foreskin (being uncircumcised) did not add a statistically significant risk for HIV infection for the men having unprotected insertive anal sex (top) with an HIV-positive partner. They went on to write, “Additional studies with more [incidents of] HIV infections or that include a larger proportion of uncircumcised men may provide a clearer answer as to whether circumcision is associated with lower rates of HIV infection among MSM who engage in insertive anal sex with HIV-infected partners.”

The report was presented at the 2009 National HIV Prevention Conference, held by the U.S. Centers for Disease Control and Prevention (CDC) in Atlanta in August.

CDC factsheet on HIV therapy and transmission

Have you heard about the use of HIV medications to prevent transmission of HIV? Keeping track of all the reports is difficult. In August, the U.S. Centers for Disease Control and Prevention (CDC) issued another of its fabulous factsheets, this one titled “Effect of Antiretroviral Therapy on Risk of Sexual Transmission of HIV Infection and Superinfection.” Read it at www.cdc.gov.

BROTHERS, a national black male study

The HIV Prevention Trials Network (HVTN) is now enrolling black men who have sex with men (MSM) in a national study designed to look at ways to reduce the high rate of infection in this population. The BROTHERS (Broadening the Reach of Testing, Health Education, Resources and Services) Project will look at various prevention strategies. These include HIV testing, counseling, and treatment referrals for HIV and other sexually transmitted infections and providing a peer health “navigator” to help black MSM (including transgender people born male or male-identified) who are HIV-positive or at high risk of infection obtain health care and services. The study takes place in six cities: Atlanta, Boston, Los Angeles, New York City, San Francisco, and Washington, D.C. In Los Angeles, the UCLA Center for Health Promotion and Disease Prevention (CHPDP) will follow 400 black MSM over two years. According to a UCLA press release, “The study’s researchers also hope to capture information that will allow for a better understanding of black MSM—their lives and experiences, their risks, their attitudes, the prejudices they face, and their strengths, and how it all relates to risk for HIV infection.”

For more information on study eligibility and a site near you, call (866) 449-8252 toll-free.

New online program for the post-incarcerated

Test Positive Aware Network (TPAN) and the AIDS Foundation of Chicago (AFC), in conjunction with the National Library of Medicine (NLM) AIDS Community Outreach Project, are launching an online education and service referral program for Illinois persons living with HIV who have been in the corrections system. The program is called PEERSpeak—Peer Empowerment Education Referral Station—and covers HIV-related issues specific to post-incarcerated people. Individuals will be able to visit the interactive site to learn about HIV basics, disclosure, and treatment, as well as to receive names and contact information of specific organizations providing services to HIV-positive people who have been in the corrections system.

Stay tuned to www.tpan.com and www.aidschicago.org for the launch of the program. For more information, call Joe Benjamin, at TPAN, at (773) 989–9400, ext 238.

OI guidelines for exposed and infected children updated

The National Institutes of Health (NIH) has issued updated Guidelines for the Prevention and Treatment of Opportunistic Infections (OIs) in HIV-Exposed and HIV-Infected Children. Visit www.aidsinfo.gov to see the updated guidelines.

Major changes in the pediatric guidelines include:

• Emphasis on the importance of effective antiretroviral therapy to improve children’s immune function.
• Information on diagnosing and managing immune reconstitution inflammatory syndrome (IRIS).
• Information on the management of antiretroviral therapy in children with OIs, including potential drug-drug interactions.
• New guidance on use of antibiotic drugs to prevent Pneumocystis jirovecii pneumonia (PCP) in infants. With advances in diagnostic testing and effective prevention of mother to child transmission, the new guidelines note that if infants have two negative tests for HIV at early timepoints (one at 2 weeks or older and one at 4 weeks or older), use of antibiotics to prevent this infection may be avoided.
• Updated immunization recommendations for HIV-exposed and -infected children.
• A new section outlining treatments for malaria.
• New recommendations on when to discontinue medication for preventing opportunistic infections.
  

AIDS Activists Issue Grades to Drug Companies

The AIDS Treatment Activists Coalition’s (ATAC) Drug Development Committee released its first annual Pharmaceutical Company HIV/AIDS Report Card on September 10. The Report Card ranks the nine pharmaceutical companies (Abbott Laboratories, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Hoffman La Roche, Merck & Co., Pfizer, and Tibotec) which have HIV/AIDS drugs on the market.

“There’s an opportunity now to kick it up a notch,” said Bob Huff, antiretroviral treatment director of the Treatment Action Group in New York and a board member of ATAC.

Twenty-one members of ATAC, a nonprofit group formed in 2001, researched the drug companies, interviewed executives, and assigned grades assessing performance over the last quarter century, Huff said. The companies were scored on research and development, pricing, patient assistance programs, marketing, and community relations.

The report card graded the drug makers overall with a below-average C-minus and recommended improvements. The highest grade, B, went to both Merck & Co. and Tibotec Pharmaceuticals. Tibotec President Glenn Mattes, in a statement, said, “We have worked purposefully and sincerely in developing our relationship with the HIV community since the company’s inception. The HIV community has played a vital role in helping us to develop our access programs and pricing approach, as well as GRACE, the largest women’s study of its kind. Our partnerships with the community have had a positive impact on the people living with HIV whom we serve.”

Abbott Laboratories received the lowest grade, an F, due in part to its 2003 400% increase in the price of Norvir. An Abbott spokesman, Dirk van Eeden, responded Wednesday, “The HIV community is an important stakeholder for us, so yes, we do take notice of the comments they make.” He added, “We really believe we’ve discovered important medicines and played our part in making sure the patients who need it can get it.”

Lynda Dee, a member of ATAC’s Drug Development Committee, said, “The report’s findings show that some pharmaceutical companies are clearly doing a much better job than others, and the common denominator among those companies who scored higher is their willingness to partner with the HIV advocacy community early on in the course of drug development, as well as implementing its recommendations. The aim of the report card project is to ultimately lay out a clear course of action for companies to take in their HIV/AIDS drug development efforts, which would be a win not only for the companies, but for consumers as well.”

To view the full report card, executive summary, criteria for scoring, and backgrounder with current statistics on the state of the HIV/AIDS epidemic, visit http://atac-usa.org/assets/files/pharmreportcard/PharmReportCard.pdf. 

back to top