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Completion of a recent study in 868 HIV/HCV co-infected patients provided evidence for the benefits of pegylated-interferon combination therapy in this population, achieving a 40% sustained viral response. Datamonitor's Shamim Kazmi says this tangible treatment strategy could fulfill a high unmet therapeutic need in this niche group... In recent years, hepatitis C (HCV) infection has become the most important chronic disease to infect HIV patients in the developed world. In 'Stakeholder Opinions: HIV/HCV Co-infection' Datamonitor provides the epidemiology of HCV and HIV infections in the seven major markets, along with a review of the HIV/HCV co-infected patient population. Treatment of both mono-infection and co-infection is evaluated, with a view to potential niche market penetration. Analysis of current companies within the HIV and HCV market sectors is provided and recommendations for future directions are determined. Niche populationEffective management of the HIV/HCV co-infected population is notoriously difficult. This is chiefly due to the exacerbation of the hepatitis C disease state by HIV co-infection, accelerating the progression of liver disease. The growing incidence of HIV/HCV co-morbidity is a perturbing trend, with an estimated 30-40% of HIV-positive individuals co-infected with the hepatitis C virus. This is often a difficult sector to treat. Historically, interferon-based therapeutics for this niche population have resulted in a poor treatment response and a high rate of adverse side effects. Moreover, many efficacious antiretroviral drugs used to treat the HIV infection are highly hepatotoxic, aggravating the HCV co-infection and consequently increasing the patient's mortality. Treatment options for this niche sector have lacked appropriate focus for three key reasons. Firstly, unlike HIV therapy, HCV treatment access has generally been derived from existing resources. Secondly, the majority of clinical trials for HCV therapeutics have excluded those co-infected with HIV. Finally, HCV genotype governs response to treatment therefore presenting further treatment complications. Data supports combination therapyResults from the 72-week APRICOT Trial (AIDS Pegasys Ribavirin International Co-infection Trial) presented at the 11th Conference on Retroviruses and Opportunistic Infections, utilizing Roche's pegylated-interferon drug Pegysus in combination with their ribavirin antiviral Copegus in 868 co-infected patients, has demonstrated the highest ever reported response rate of 40% in this co-morbid population. The sustained viral load rates (SVR) with the combination regimen were superior to the Pegysus monotherapy (20% SVR) and conventional interferon/ribavirin (12% SVR) arms. The results from combination therapy in the less responsive HCV genotype 1 also achieved a four-fold increase in SVR compared to conventional interferon/ribavirin (29% versus 7%). Two additional studies presented at this conference, ACTG-A5071 and RIBAVAC, also investigating the efficacy of pegylated interferon combination therapy using Roche's Pegysus and Schering-Plough's Peg-Intron respectively. Both demonstrated lower response rates than those outlined in the APRICOT trial. However, conclusions drawn from the three trials must be interpreted with caution as differing trial design may have impacted on the outcome of events. Head-to-headThe high rate of relapse observed in the ACGT-A5071 study may have been the result of ribavirin timing and dosage. Similarly the Ribavac study featured a harder to treat HCV genotype 1 population. Therefore direct comparisons from these trials are difficult and do not elucidate the real clinical efficacy of the two pegylated interferon formulations from Roche and Schering-Plough and cannot confer a superior HIV/HCV market potential to either company. A head-to-head comparator trial of Pegysus and Peg-Intron is currently underway and may reveal a superior efficacy and tolerability profile for one of the pegylated interferons conferring an advantageous position in this niche therapeutic market to either company. A favorable outcome for Roche may increase its market share in the HCV therapeutic arena, which is currently dominated by Schering-Plough (92.2%). Specific targeting of this niche population coupled with Roche's strong experience and market presence in the HIV arena will assist in raising its profile in the HCV drug market. Furthermore, the results from all three studies provide a tangible therapeutic strategy, giving renewed hope for successful treatment of individuals co-infected with HIV/HCV. If you found
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