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News and Literature Reviews

August 2005


Errata

In the IDCR, "An HIV-Infected Inmate with an abnormal Cervical Pap Test" case study, one error occurred. On page five, column one, paragraph three, the last sentence should read "Of note, moderate to severe cervical dysplasia is considered a symptomatic condition of HIV since it may indicate a defect in cell-mediated immunity and has a clinical course that may be complicated by HIV (AIDS surveillance case definition 1993). If the inmate described in the case has cervical intraepithelial neoplasia (CIN) grade 2 or CIN 3 detected on colposcopy, she would meet the case definition for Stage B HIV infection and should then be offered ART." Corrected PDF version available at www.idcronline.org.
CDC. MMWR. 1992; 41:1-9


High Rates of ART Prevalence, Unrecognized Infection Among MSM

During June 2004-April 2005, 2,261 men sampled from five National HIV Behavioral Surveillance (NHBS) cities were surveyed regarding their sexual and drug-use behaviors, HIV testing behavior, and use of HIV prevention services. Of the 2,261 men sampled, 78% had one or more male sex partner; of these, 25% tested positive for HIV. HIV prevalence among African-Americans, Caucasians and Hispanics was 46%, 21% and 17%, respectively. Unrecognized infection was 64%, 18%, 11% and 6% among African-Americans, Hispanics, Caucasians and multiracial persons, respectively.
CDC. MMWR. 2005; 54(24):597-601.


Induction/Maintenance Redux?

Markowitz, et al. conducted a randomized, 96-week study to determine if a four-drug induction followed by a three-drug maintenance as initial ART therapy reduces HIV RNA rapidly, while allowing patients to later switch to a more simplified, effective and tolerable regimen. During the 48-week induction period, 448 patients were treated with one fixed-dose tablet of ABC (300 mg)/3TC (150 mg)/ZDV (300 mg) twice daily plus EFV (600 mg) once daily. After the induction phase, study participants were randomized to continue 4-drug therapy or discontinue EFV. At 96 weeks, no significant differences were noted for an HIV RNA level <50 copies/mL. Drug-related adverse events were more commonly reported for 4-drug therapy than for ABC/3TC/ZDV and a greater proportion of patients receiving ABC/3TC/ZDV than 4-drug therapy reported perfect adherence. Study authors concluded that after induction with ABC/3TC/ZDV plus EFV, simplification to ABC/3TC/ZDV alone maintained virologic control, reduced ART-associated adverse events and improved adherence.
Markowitz, et al. JAIDS. 2005; 39(3):257-64.

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Moderate, but Climbing, Rates of ART Resistance in ART-Naive Patients

Kaplan-Meier estimation was used in analysis of data from the UK Collaborative HIV Cohort (UK CHIC) study to assess the proportion of patients who experience viral load failure, defined as two consecutive viral load values >1,000 copies/mL at least six months after ART initiation, or one value followed by the initiation of at least one new drug, by a given time. By Kaplan-Meier estimation, viral load failure occurs in 21%, 30%, and 38% of patients by two, four, and six years after ART initiation, respectively. Kaplan-Meier estimates of the percentage of patients demonstrating at least one resistance mutation two, four, and six years after ART initiation was 9%, 19%, and 27%, respectively. Factors associated with a greater risk of resistance mutations included younger age, unknown HIV exposure, viral load greater than 100,000 copies/mL at ART initiation, and CD4 cell count less than 200 cells/mm3 at ART initiation.
Phillips, A. AIDS. 2005; 19(5):487-94.


Tipranavir Approved for Treatment-Experienced Patients

Tipranavir was approved by the Food and Drug Administration on June 22, 2005 for treatment-experienced patients. The recommended dose is 500 mg (two 250 mg capsules), co-administered with 200 mg ritonavir, twice daily. Tipranavir should be taken with food; bioavailability is increased with a high fat meal. Consideration should be given to separating tipranavir/ritonavir dosing from antacid administration to prevent reduced absorption of tipranavir. Tipranavir is associated with hepatotoxicity and clinical hepatitis, and is contraindicated in patients with moderate to severe hepatic insufficiency.
FDA News. (n.d.). Retrieved July 8, 2005.


New Approval, Old News to AIDS Providers

On July 6, 2005, the Food and Drug Administration approved Megace ES (megestrol acetate), a concentrated oral suspension for the treatment of anorexia, cachexia or unexplained, significant weight loss in AIDS patients. The approval was based on pharmacokinetic studies demonstrating bioequivalence between 625 mg of Megace ES and 800 mg of megestrol acetate oral suspension. Megace ES is taken once-daily at a 625 mg dose.
Par Pharmaceuticals Featured Products. (n.d.). Retrieved July 14, 2005.


Clinicians Should Monitor for Nephrotoxicity in TDF-Treated Patients

Tenofovir disoproxil fumarate (TDF), a nucleoside reverse transcriptase inhibitor (NRTI) approved for the treatment of HIV disease, may cause nephrotoxicity in TDF-treated patients with prolonged use, particularly in patients with advanced HIV disease, diabetes, or decreased renal function at baseline. While TDF has not been associated with nephrotoxicity in clinical trials, adefovir dipivoxil, a related NRTI, has caused proximal renal tubular dysfunction at a dosage of 60-120 mg/day. Clinicians should assess renal function prior to initiating TDF therapy and continue to monitor renal function in all TDF-treated patients.
Gallant J, et al. Clin Infect Dis. 2005; 40: 1194-98.


Risk Factors for TDF-Induced Nephrotoxicity

Antoniou, et al conducted a retrospective study of 172 HIV-infected ARV treatment-experienced adults to describe the incidence and potential risk factors for TDF-associated nephrotoxicity. Baseline viral load, serum creatinine (SCr) and creatinine clearance (CrCl) were 374 log10 copies/ml, 81.5mmol/L and 101ml/min, respectively. During follow-up, 4% of patients developed grade 1 increases in SCr, no patient developed grade 2 or higher nephrotoxicity and 8.7% of patients had a 1.5-fold or greater increase in SCr relative to baseline. The median SCr at baseline among patients who had a 1.5-fold increase in SCr was significantly lower than that of patients who did not (62µmol/L vs 82µmol/L). The median CrCl at baseline among patients with a 1.5-fold increase was significantly higher than that of patients without the increase (117mL/min vs 100ml/min.) In univariate analysis, only baseline SCr and baseline CrCl were associated with the development of a 1.5-fold or higher increase in serum SCr relative to baseline. Study authors concluded that while baseline SCr and CrCl were significantly associated with nephrotoxicity, clinically significant nephrotoxicity was rare. Study authors were unclear why the results would suggest that patients with seemingly healthier kidneys at baseline were more predisposed to developing this complication.
Antoniou T, et al. HIV Medicine. 2005; 6:284-90.


HCV and Arthritis -- Treat With IFN?

Extrahepatic manifestations associated with HCV, including arthritis, are well known. However, HCV-related arthritis in the absence of clinical, biochemical and histological evidence of liver disease is not common. Abbasi, et al reported on a patient with a history of an abrupt onset of bilateral painful swelling of small joints in the hands, elbows, knees and ankle joints, which had persisted for four weeks. Swelling decreased significantly within two weeks after initiation of 300 mu interferon alfa 2b three times weekly. Swelling disappeared completely after six weeks of IFN therapy and HCV RNA titers were undetectable at six months. Study authors concluded that this extrahepatic condition may have been the direct result of HCV infection.
Abbasi J, et al. Med Sci Monit. 2005; 11(7):37-9.


Cultural Competence: Applied to Corrections

While the United States has witnessed dramatic improvements in sciences and technologies in HIV medicine, disparities in access to care persist among ethnic, racial and gender minority populations.

To this end, the National HIV Advisory Council on HIV Health Disparities convened on June 23-25 in San Juan, Puerto Rico in preparation for the Summit on National Guidelines for Culturally and Linguistically Appropriate Healthcare Services in HIV for Ethnic and Gender Minority Communities, which will be held in Washington DC during May 2006. The mission of the Summit Meeting is to create national guidelines for clinical approaches and research, public policy, and prevention and education programs that address disparities in HIV treatment. The Council anticipates the implementation of these guidelines by clinical and research institutions, funding and public policy agencies, community-based education, prevention, testing and counseling programs, in hopes of supporting the creation of culturally and linguistically appropriate HIV/AIDS services for the ethnic and gender minority populations they serve.

During the three-day event that took place this past June, the Council discussed and evaluated current guidelines and documented evidence on cultural competency and healthcare literacy. Guidelines will be published for three core areas: clinical and research practices, public policy and funding, and community-based education and prevention programs. National and international experts and stakeholders will evaluate these guidelines during the May 2006 Summit and dissemination of the guidelines will begin in fall 2006.
National HIV Advisory Council on HIV Health Disparities Summit Committee Planning Meeting. San Juan, Puerto Rico. June 23-25, 2005.


CA Prison Goes Into Receivership

The California prison health care system recently went into receivership after U.S. District Judge Thelton Henderson of San Francisco ordered that a receiver take control of California's prison health care system and correct what he felt were unacceptable conditions. Henderson's decision came after testimony from medical experts citing that 64 preventable deaths of inmates occur per year in the CA system, while numerous others are injured. Currently, there are 164,000 inmates in California's 33 state prisons and $1.1 billion is spent per year by the state on prison health care. As of yet, Judge Henderson has not appointed a permanent receiver.
Sterngold, J. San Francisco Chronicle. Accessed July 3, 2005.


HIV Care at Limestone Correctional Facility

The New York Times (NYT) recently reported on alleged inadequate medical care of HIV-infected inmates at the Limestone Correctional Facility, located in Huntsville, Alabama. From 1999 to 2002, 36 male inmates with HIV and AIDS died, prompting inmates to sue and the government to promise change. The local company charged with the medical care of the inmates at Limestone was fired and Prison Health Services (PHS) was hired. PHS then hired Dr. Valda Chijide, an infectious disease specialist, who was suspended after three months of work for reasons PHS would not disclose, after which she quit. PHS has reduced the number of inmate deaths (four during its' two years working at Limestone,) but according to the NYT, there is still much work to be done.
Von Zielbauer, P. New York Times. Accessed August 5, 2005.



  
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This article was provided by Brown Medical School. It is a part of the publication Infectious Diseases in Corrections Report.
 

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