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News from ICAAC 2013

Promising clinical trial results for a number of antiretroviral treatments, and further evidence for anal dysplasia screening, were presented at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, USA, last week.

Trials highlight effective drugs with fewer side effects

Stribild

The results from two phase 3 trials indicate that Stribild, the single daily pill that combines elvitegravir, cobicistat, tenofovir, and emtricitabine, is as effective in controlling HIV in the over 50s as it is in younger adults.

People over 50 gained fewer CD cells on treatment, however this was not thought to be a significant difference. The rate of serious adverse events did not differ greatly between the two age groups. These are important results that contribute to knowledge of best treatment options for an ageing global population of people with HIV.

Stribild and Comparison Combinations Have Similar Efficacy in Over-50s and Under-50s  National AIDS treatment Advocacy Project (NATAP) report

Raltegravir Top PIs and NNRTIs in Retrospective Look at Cancer Patients  NATAP report

Tenofovir

Another study found that substituting Tenofovir alafenamide (TAF) for tenofovir disoproxil fumarate (TDF) in Stribild is just as effective as TDF, with fewer adverse effects on kidney function and bone density. This is because the TAF formulation is more concentrated in HIV-infected cells, but levels on the blood are much lower than is the case for TDF.

Tenofovir is used in several combination pills including Truvada, (approved in the US for pre-exposure prophylaxis (PrEP)), so if TAF is approved for use it will be a welcome improvement to these combinations. Phase 3 trials are underway.

New tenofovir formulation works equally well with less effect on kidneys and bones AIDSmap report

TAF Comparable to TDF in Once-Daily Pill for ART-Naive: 48-Week Results NATAP report

Dolutegravir

Dolutegravir, an integrase inhibitor approved for use by the US Food and Drug Administration in August, has continued to perform well in clinical trials.

The FLAMINGO trial shows that dolutegravir achieved better viral suppression than darunavir/ritonavir, with fewer adverse effects, in adults who had not previously been treated with antiretroviral therapies.

Dolutegravir Superior to Darunavir at 48 Weeks in Open-Label ART-Naive Trial NATAP report

Pregnancy

A US study of 65 HIV-positive pregnant women found little difference in the experience of side effects between high-dose atazanavir/ritonavir (ATV/r) or lopinavir/ritonavir (LPV/r).

The study was undertaken becuase there is little evidence on adverse effects related to high dose protease inhibitor (PI) for pregnant women, although higher doses have become standard because the drug concentration can fall during pregnancy.

The main adverse effects with ATV/r were hyperbilirubinemia (high levels of the waste product bilirubin) and vaginal bleeding or discharge. The most common adverse effects with LPV/r were nausea or vomiting, hyperbilirubinemia and transaminitis (high levels of liver enzymes).

Adverse Event Rates Similar With High-Dose ATV/r and LPV/r During Pregnancy NATAP report

Cancer

Raltegravir

A retrospective analysis of the effectiveness of antiretroviral therapy (ART) in people with HIV on chemotherapy for cancer has found that the integrase inhibitor raltegravir (Isentress) may be the best treatment choice.

The US study, which looked at the records of 154 people with different kinds of cancer on various ART regimens, found that people on raltegravir were six times more likely to achieve sustained suppression on HIV than those on protease inhibitor-based regimens (PIs).

People on  non-nucleoside reverse transcriptase inhibitor (NNRTIs) were nine times more likely to achieve viral suppression than people on PIs; however mortality was significantly higher than among people taking raltegravir.

The researchers recommended prospective studies be undertaken to help define optimum treatment regimens for HIV-positive people on chemotherapy.

Raltegravir is a good choice for people with HIV undergoing cancer chemotherapy AIDSmap report

Anal cancer and women

A Spanish study has found that one in five women with HIV, and two thirds of HIV-positive men who have sex with men (MSM), have anal dysplasia. Anal dysplasia may be a precursor to anal cancer.

The researchers recommend that although rates of anal cancer are lower among women than among MSM, these findings indicate a need for routine screening for abnormal anal cells in HIV-positive women.

One in 5 HIV+ Women in Spanish Group Has Anal Dysplasia, Predicted by Warts NATAP report

Anal cancer and men who have sex with men

The same study found that infection with  human papillomavirus (HPV) type 39 is the only independent predictor of grade 2 or 3 anal intraepithelial neoplasia (AIN) or anal cancer among HIV-positive MSM.

The researchers called for systematic and comprehensive screening of HIV-positive MSM.

HPV-39 Predicts AIN and Anal Cancer in Spanish Group of Men with HIV NATAP report


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This page was published on 16 September, 2013